The Food and Drug Administration: Budget and Statutory History, FY1980-FY2007

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The Food and Drug Administration: Budget

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RL34334

CRS Report for Congress

Prepared for Members and Committees of Congress

The Food and Drug Administration: Budget and Statutory History, FY1980-FY2007

Summary

Considerable attention has been focused on the ability of the Food and Drug Administration

(FDA) to accomplish its mission with the funds provided by congressional appropriations and

user fees. FDA regulates a wide range of products valued at more than $1 trillion in the U.S.

economy. The agency plays a key public health role. FDA is responsible for the safety of most

foods (human and animal) and cosmetics, and it regulates both the safety and the effectiveness of

human drugs, biologics (e.g., vaccines), medical devices, and animal drugs.

In congressional hearing testimony and at other public venues, former FDA Commissioners,

interest group representatives, and former high-ranking individuals in the agency or in the

Department of Health and Human Services have argued that FDA is underfunded and at risk of

being unable to fulfill all the statutory responsibilities assigned by Congress. Reports by the

Institute of Medicine, the Government Accountability Office, and the FDA Science Board have

made similar observations. The main voices in support of FDA budget levels, past and present,

have been representatives of the various presidential administrations. Calls for cutting the FDA

budget or maintaining it at the current level come from organizations, such as CATO and the

Hoover Institute, that propose limitations on the agency’s authority and, therefore, its need for

funding. Some agency critics have expressed concerns about inefficiencies within FDA and its

ability to manage its resources.

In order to inform the ongoing discussion about FDA, this report presents FDA’s appropriations

history and traces the evolution of the agency’s statutory responsibility. It first provides a 28-year

budget history for the agency along with personnel levels as shown by the number of full-time

equivalent employees (FTEs). This report found that direct congressional inflation-adjusted

appropriations (budget authority) to FDA doubled, and that the contribution of other funds,

mostly user fees, increased more than 12-fold, resulting in an overall budget in FY2007 almost

2½ times that in FY1980. Between FY1980 and FY2006, the latest year with final FTE data, the

agency’s FTE level increased 19% overall, from a less than 1% increase in budget authorityfunded FTEs and an almost fourfold increase in FTEs funded by other sources (mostly user fees).

The report also provides a more detailed examination of the budget and personnel levels for each

of FDA’s major activity areas: Foods, Human Drugs, Biologics, Animal Drugs and Feeds, and

Devices and Radiological Health. Findings include the relationship of user fees to budget

authority, declining funding of research, and summaries of the major laws enacted since FY1980.

Congressional Research Service

The Food and Drug Administration: Budget and Statutory History, FY1980-FY2007

Contents

Introduction ................................................................................................................................1

Agency Scope and Congressional Jurisdiction.............................................................................2

FDA Budget and Personnel .........................................................................................................4

Overall FDA Budget .............................................................................................................4

Comparison of FDA Budget with Other Agency Budgets ......................................................7

FDA Activity-Area Budgets ................................................................................................ 12

Impact of New Statutory Authorities on FDA Budget .......................................................... 14

FDA Regulatory Research................................................................................................... 15

FDA Science Board Report ................................................................................................. 17

Major Activity Areas: Budget and FTEs .................................................................................... 19

Foods.................................................................................................................................. 19

Human Drugs...................................................................................................................... 23

Biologics ............................................................................................................................ 27

Animal Drugs and Feeds ..................................................................................................... 30

Devices and Radiological Health......................................................................................... 34

Other Activities and Responsibilities ................................................................................... 37

Toxicological Research ................................................................................................. 37

Headquarters and Office of the Commissioner............................................................... 38

Field Activities: The Office of Regulatory Affairs.......................................................... 38

Concluding Comments.............................................................................................................. 38

Figures

Figure 1. FDA: Budget and FTEs................................................................................................6

Figure 2. Budget Authority for FDA, CDC, and NIH...................................................................8

Figure 3. FDA Budgets for FY1980 and FY2006, by Major Activity Area and Type of

Funding ................................................................................................................................. 14

Figure 4. FDA Research in Five Activity Areas (Constant FY2000 $) ........................................ 16

Figure 5. Foods: Budget and FTEs(Constant FY2000 $)............................................................ 23

Figure 6. Human Drugs: Budget and FTEs (Constant FY2000 $)............................................... 24

Figure 7. Biologics: Budget and FTEs (Constant FY2000 $)...................................................... 29

Figure 8. Animal Drugs and Feeds: Budget and FTEs(Constant FY2000 $) ............................... 32

Figure 9. Devices and Radiological Health: Budget and FTEs (Constant FY2000 $).................. 36

Tables

Table 1. Summary of Increase in Total Budget and FTEs, FY1980 and FY2006 (Constant

FY2000 $) ............................................................................................................................. 13

Table 2. Foods Statutory Authorities in 1980 and 2007 .............................................................. 21

Table 3. Human Drugs Statutory Authorities in 1980 and 2007 .................................................. 26

Congressional Research Service

The Food and Drug Administration: Budget and Statutory History, FY1980-FY2007

Table 4. Biologics Statutory Authorities in 1980 and 2007......................................................... 30

Table 5. Animal Drugs and Feeds Statutory Authorities in 1980 and 2007................................. 33

Table 6. Devices and Radiological Health Statutory Authorities in 1980 and 2007 ..................... 37

Table A-1. Actions Taken to Address FDA Budget Data Limitations .......................................... 44

Table A-2. FDA Appropriations, Overall and by Major Program, Budget Authority and

Other Funding, FY1980 through FY2008, Unadjusted for Inflation ........................................ 46

Table A-3. Full-time Equivalents, Overall and by Major Program, Budget AuthorityFunded and Other-Funded, FY1980 through FY2008 ............................................................. 48

Table A-4. Selected Public Laws Since 1848 Significantly Affecting FDA Activities ................. 50

Appendixes

Appendix. Methodology............................................................................................................ 42

Contacts

Author Contact Information ...................................................................................................... 57

Congressional Research Service

The Food and Drug Administration: Budget and Statutory History, FY1980-FY2007

Introduction

There is growing debate about whether the Food and Drug Administration (FDA) has the ability

to accomplish its mission with the resources provided by congressional appropriations and

industry user fees. FDA plays a central role in protecting the public health in the United States by

regulating most of the food supply and vitally important medical products, including drugs,

devices, and biologics that affect American lives on a daily basis. A 2006 report on drug safety by

the Institute of Medicine (IOM) made the following observation in a chapter devoted to FDA

resources:

The Food and Drug Administration lacks the resources needed to accomplish its large and

complex mission today, let alone to position itself for an increasingly challenging future....

There is little dispute that FDA in general is ... severely underfunded.1

Several individuals who previously held high-ranking positions in FDA or the Department of

Health and Human Services (HHS) have organized advocacy groups to lobby for increased

funding for the entire agency.2 These groups present data to support their position that FDA has

fallen behind in overall funding in the last 25 years. They warn that the agency is at risk of being

unable to adequately fulfill the many statutory responsibilities that Congress has assigned it.

While the call for more resources has been heard from many quarters, including some in

Congress, some agency critics are concerned about inefficiencies within FDA and that it needs to

do a better job managing what resources it does have.3

In general, former FDA Commissioners and interest groups argue that FDA is underfunded for its

mission. Calls for cutting the FDA budget or maintaining it at the current level come from

organizations, like CATO and the Hoover Institute, that propose limitations on FDA’s authority

and, therefore, the need for funding. The main voices in support of FDA budget levels, past and

present, have been representatives of the various presidential administrations. Over the last 25

years, incumbent FDA Commissioners, when asked during congressional hearings about the

adequacy of the FDA budget, have testified that the budget is sufficient to accomplish the job

before the agency. However, in non-congressional venues, those same Commissioners have

expressed concerns about the constraints on FDA resources and that the agency’s core budget has

not increased in concert with its rising responsibilities. They have expressed concern about

whether the agency can continue to be considered the world’s premier consumer protection

agency when it is forced to focus its priorities based on the current level of resources that it

receives. 4

Institute of Medicine (IOM), The Future of Drug Safety: Promoting and Protecting the Health of the Public, Alina

Baciu, Kathleen Stratton, Sheila P. Burke, Editors, Committee on the Assessment of the US Drug Safety System, Board

on Population Health and Public Health Practice (Washington, DC: National Academies Press, 2006), p. 193.

The Coalition for a Stronger FDA, at http://www.fdacoalition.org/the-coalition-for-a-stronger-fda, and the FDA

Alliance, at http://www.StrengthenFDA.org. In December 2007 the boards of these two groups announced their

intention to merge; details of the merger have not been finalized (“Coalitions Lobbying for More FDA Money Are

Merging,” FDA Week, vol. 13, December 14, 2007).

IOM, The Future of Drug Safety, 2006, p. 81; and Representative Rosa DeLauro, “Statement on FDA Science Board

Report,” December 3, 2007, at http://delauro.house.gov/release.cfm?id=697.

Andrew C. von Eschenbach, “State of the FDA,” Food and Drug Law Journal, vol. 62, 2007, pp. 423-427; and Jane

E. Henney, “Remarks of the Commissioner of Food and Drugs,” Food and Drug Law Journal, vol. 54, 1999.

Congressional Research Service

The Food and Drug Administration: Budget and Statutory History, FY1980-FY2007

This report examines FDA’s appropriations history and traces the evolution of the agency’s

statutory responsibilities. The information is presented to help inform the ongoing discussion

about FDA. CRS takes no position on whether the agency has the necessary resources to meet its

statutory responsibilities.

The report first provides an overview of FDA’s budget and personnel levels from FY1980 through

FY2007.5 That is followed by a more detailed examination of the budget and personnel level over

the same period in each of the agency’s major activity areas. For each activity area, the report also

summarizes the major pieces of legislation that have been enacted since FY1980. Unless noted

otherwise, all budget data have been adjusted for inflation to permit comparison across the 28year period under investigation. The information presented in this report is intended to facilitate

an examination of the impact that administrations’ budget requests and congressional decision

making have had on the ability of FDA to accomplish its public health mission.

Agency Scope and Congressional Jurisdiction

FDA regulates a wide range of products valued at more than $1 trillion in the U.S. economy.

About 25% of American consumer dollars are spent on these FDA-regulated products.6 As one of

the agencies within HHS that comprise the Public Health Service, 7 FDA is responsible for the

safety of most foods (human and animal) and cosmetics. FDA also regulates both the safety and

the effectiveness of human drugs, biologics (e.g., vaccines), medical devices, and animal drugs.

The Federal Food, Drug, and Cosmetic Act (FFDCA), as amended, is the principal source of

FDA’s authority. 8 The agency also derives some of its authority from certain provisions in other

laws, most notably the Public Health Service (PHS) Act. Under the PHS Act, FDA licenses

biological products9 and performs other activities, such as setting standards for mammography

quality. 10 An extensive list of the public laws that significantly affect FDA activities is in Table A4 in the Appendix.

In addition to statutory responsibilities that directly involve product regulation, the FDA must

also comply with statutory requirements affecting all or most federal executive agencies,

regarding such matters as information management, strategic planning, performance

measurement, financial management, property management, and human resources management.11

Additional requirements apply only to those agencies, including FDA, that have regulatory

Congress had not acted on FDA appropriations for FY2008 at the time this report was being prepared. Except for

Figure 4, the figures in this report do not include FY2008 budget or FTE levels.

Food and Drug Administration (FDA), “Frequently Asked Questions (FAQs),” at http://www.fda.gov/opacom/faqs/

faqs.html.

CRS Report RL34098, Public Health Service (PHS) Agencies: Background and Funding, by (name redacted),

coordinator.

P.L. 75-717, 1938, currently 21 U.S.C. § 301 et seq.

PHS Act § 351, 42 U.S.C. § 262.

PHS Act § 354, 42 U.S.C. § 263b.

For a listing of these laws, see CRS Report RL30795, General Management Laws: A Compendium, by (name redac

ted). Examples of general management laws with which FDA must comply include the Government Performance and

Results Act of 1993 and the Data Quality Act.

Congressional Research Service

The Food and Drug Administration: Budget and Statutory History, FY1980-FY2007

responsibilities. 12 FDA’s role in implementing provisions of some general federal management

laws is substantial. For example, the agency supports more than 50 advisory committees, most of

which are mandated in statute and are subject to requirements of the Federal Advisory Committee

Act. 13 Also, the agency reports that in FY2006 it processed more than 20,000 information

requests pursuant to requirements of the Freedom of Information Act.14

The congressional authorizing committees that oversee FDA activities are those with jurisdiction

over public health issues: the Senate Committee on Health, Education, Labor, and Pensions, and

the House Committee on Energy and Commerce. Because Medicare pays for FDA-regulated

products, the agency also falls under the jurisdiction of the Senate Committee on Finance and the

House Committee on Ways and Means. Other committees that exercise oversight roles regarding

FDA include the House Committee on Oversight and Government Reform, and the Senate

Committees on Aging, Homeland Security and Governmental Affairs, and the Judiciary.

The House and Senate Appropriations subcommittees on agriculture have jurisdiction over FDA’s

appropriations. This arrangement reflects, in part, the agency’s origin within the Department of

Agriculture as the Bureau of Chemistry in 1862. Since 1940, FDA has administratively been part

of federal health agencies, specifically HHS and its predecessors.15

Advocates for increasing FDA funding point to this jurisdictional separation of FDA

appropriations decisions from the rest of PHS and HHS as a contributing factor to what they see

as underfunding. In 2002, former Acting FDA Commissioner Michael Friedman recommended

moving the FDA budget process from the purview of the agriculture appropriations

subcommittees to the Labor, Health and Human Services, Education and Related Agencies

subcommittees.16 Five years later, former FDA Commissioner Frank Young raised the same

concern and made the same recommendation in congressional testimony. 17 Former FDA

Commissioner Jane Henney made a similar observation in February 2007:

[T]here are other things Congress can do that directly impact this agency’s resources ... if

they really wanted to look long and hard, FDA would no longer be under the purview of the

Agriculture Appropriations Committees. Those people that serve on those committees do it

with honor, but they do it primarily because of their interest in agricultural issues. By the

time the allocations come out and the interest of the agriculture areas are satisfied, there are

very limited resources that the agency [FDA] can ever hope to receive out of that process. If

somebody wanted to do something bold ... it would be looking at appropriations in an area

that is more compatible ... with the interests of the members of that committee particularly

the ones that oversee health issues.18

Examples of regulatory management laws with which FDA must comply include the Administrative Procedure Act

and the Regulatory Flexibility Act of 1980.

5 U.S.C. Appendix. For more information, see “FDA Advisory Committees” at http://www.fda.gov/oc/advisory/

default.htm.

For more information, see FDA, “Freedom of Information Annual Report—FY2006,” at

http://www.fda.gov/foi/default.htm, and 5 U.S.C. § 552.

For histories of FDA and USDA, see their respective websites, at http://www.fda.gov/opacom/backgrounders/

miles.html and http://www.fsis.usda.gov/About_FSIS/Agency_History/index.asp.

Michael A. Friedman, “Strengthening the FDA,” Science, vol. 298, December 20, 2002, p. 2332.

Frank E. Young, statement before the Committee on Oversight and Government Reform, U.S. House of

Representatives, May 1, 2007, p. 5, at http://oversight.house.gov/documents/20070501193917.pdf.

Policy Workshop on Strengthening the FDA, Project on Scientific Knowledge and Public Policy, George

(continued...)

Congressional Research Service

The Food and Drug Administration: Budget and Statutory History, FY1980-FY2007

FDA Budget and Personnel

Overall FDA Budget

The primary indicator of FDA resources is its budget. The agency’s FY2007 total budget is

approximately $2 billion. 19 The total FDA budget, also called the program level, consists of (1)

direct appropriations and (2) other funds (i.e., funding from other sources that are acknowledged

in the appropriations acts). Direct appropriations are the amount of funds that Congress assigns to

the agency from the annual total available for appropriations as set by the budget committees.

Other funds include reimbursables, cooperative research and development agreement (CRADA)

resources, intra- and inter-agency services (such as the Parklawn Computer Center),

mammography fees, color certification fees, export certification fees, prescription drug user fees,

medical device user fees, and animal drug user fees.

FDA annually prepares budget data for Congress that it presents in the Justification of Estimates

for Appropriations Committees (Justification) documents. FDA transmits its draft through HHS to

the White House Office of Management and Budget (OMB). The final Justification documents,

reflecting any HHS and OMB adjustments, are published with the President’s annual budget

request to Congress. The final Justifications are the major source of FDA budget figures and

tables in this report. Like most federal agencies, FDA has, over time, reorganized its structure,

activities, and budget accounting, which makes historical budget analysis a difficult endeavor. For

further information on the difficulties in compiling a budget history of the agency, and the steps

taken to address those problems for this report, see the Methodology section in the Appendix.

Until FY1992, direct appropriations formed over 95% of FDA’s total program level, with other

funds contributing the small remainder. A shift began in FY1992 when Congress authorized: (1)

the assessment and collection of user fees from pharmaceutical manufacturers for the review of

human drug and biologics applications, and (2) fees for the inspection of mammography

facilities. Congress subsequently authorized the collection of user fees for the review of medical

device applications in FY2002 and animal drug applications in FY2004. By FY2007, other funds,

primarily user fees, accounted for almost a quarter of FDA’s total program level budget.

Another indicator of agency resources is personnel, available in the Justification documents as the

number of full-time equivalent employees (FTEs). This is, however, an imperfect measure of

personnel strength because it is not weighted by type of position, pay grade, or responsibility,

each of which would provide a different measure of the agency’s human resources. FDA has

described how adjusting salaries for standard measures of inflation is inadequate because of the

unique elements of its staff expenses, such as higher than average employee salaries, cost of

health and retirement benefits, and resources required for recruitment and retention.20 FTE

numbers do not include contractors and, therefore, provide only a partial measure of workforce

(...continued)

Washington University School of Public Health and Health Services, Washington DC, February 21, 2007, transcript at

http://www.kaisernetwork.org/health_cast/uploaded_files/022107_gwu_workshop_transcript2.pdf.

FDA Operating Plan for FY2007 (March 2007), reflecting final funding levels under P.L. 110-5, Revised Continuing

Appropriations Resolution, 2007.

FDA, PDUFA IV proposal, and “PDUFA Fact Sheet,” January 11, 2007, at http://www.fda.gov/oc/pdufa4/

factsheet011107.html.

Congressional Research Service

The Food and Drug Administration: Budget and Statutory History, FY1980-FY2007

strength. If FDA’s use of non-employee workers has changed during the 28-year period covered

in this report, the numbers of FTEs may be an inaccurate measure of agency personnel strength.

Figure 1 shows the total FDA budget (i.e., program level) for FY1980 through FY2007, all

adjusted to FY2000 dollars.21 The FDA program level is composed of direct congressional

appropriations, what FDA calls budget authority, and other funds.22 Using constant FY2000

dollars allows comparisons of purchasing power over the 28-year period. The stacked bars of the

figure show the two broad sources of budget dollars: direct appropriations and other funds

(primarily user fees). The figure also provides FTE data over the same fiscal years: FTEs funded

by budget authority and total FTEs funded at program level (budget authority plus other funds,

primarily user fees).

As can be seen in Figure 1, inflation-adjusted budget authority was relatively flat from FY1980

to FY1988, began to increase from FY1989 until FY1993 when it leveled off, coincident with the

introduction of user fees in 1993. Figure 1 also shows a decline in budget authority FTEs from

FY1993 to FY2001, although the total FTEs remained relatively constant due to positions funded

by user fees.

Congressional intent in authorizing user fees was that these fees would supplement—rather than

replace—resources provided by Congress to FDA. Level funding from Congress—without

adequate allowances for inflation, mandatory salary and health insurance increases, as well as

other workload-related unfunded mandates—has resulted in declines in FTEs in areas of the

agency that do not receive user fees. A 2002 Government Accountability Office (GAO) report on

the impact of user fees resulting from the Prescription Drug User Fee Act (PDUFA) states that:

According to FDA officials, the agency reduced staffing levels ... to cover the costs of

unfunded pay raises. From fiscal years 1994 through 2001, FDA paid about $250 million to

cover mandatory federal pay raises for which it did not receive increases in its

appropriations. ... [T]his situation reduced the agency’s ability to support activities not

funded by PDUFA. FDA reduced the staffing levels for non-PDUFA activities each year,

leaving the agency fewer resources to perform its other responsibilities. For example, in its

budget justification for fiscal year 2002, FDA reported that inspection of medical device

manufacturers has decreased and the agency does not routinely inspect the manufacturers of

lower-risk products. Although FDA staffing in fiscal year 2001 was about the same as in

fiscal year 1992, about 1,000 more FTEs were allotted to drug and biologic review activities

in fiscal year 2001 and about 1,000 fewer FTEs were allotted to other FDA programs that

ensure food safety, approve new medical devices such as heart valves and pacemakers, and

monitor devices once on the market.23

“Total Non-Defense” deflators were used from Table 10.1, Gross Domestic Product and Deflators Used in the

Historical Tables: 1940-2012, found in Historical Tables, Budget of the United States, Fiscal Year 2008, pp. 192-193.

Direct congressional appropriations and funds from user fees (often called offsetting collections) both provide budget

authority to FDA. The agency, however, refers to congressional appropriations as budget authority, but not user feerelated sources of funding (which also provide budget authority but are referred to as user fees by FDA).

U.S. General Accounting Office, Food and Drug Administration Effect of User Fees on Drug Approval Times,

Withdrawals, and Other Agency Activities, GAO-02-958, September 2002, pp. 17-18.

Congressional Research Service

The Food and Drug Administration: Budget and Statutory History, FY1980-FY2007

Figure 1. FDA: Budget and FTEs

(Constant FY2000 $)

Sources: For FY1980-FY2006, FDA Justification of Estimates for Appropriations Committees documents. FY2007

FTE data are based on an interim continuing resolution used in the FY2008 Justification and therefore do not

reflect final action by Congress. FY2007 budget data reflect the Operating Plan developed after passage of P.L.

110-5, Revised Continuing Appropriations Resolution, 2007.

Notes: Total FTEs = Budget Authority FTEs + User Fee FTEs. Program Level $ = Budget Authority $ + User

Fees $.

Figure 1 also shows that budget authority and FTEs increased markedly between FY2001 and

FY2002, coincident with increased emergency funding following the domestic terrorist attacks.

However, during the FY2002 through FY2007 period, while budget authority remained flat and

other funds increased, FTEs once again declined.

In a related matter, the 2002 GAO report expressed concern about attrition among FDA staff

which it found to be noticeably greater than in similar disciplines at the National Institutes of

Health (NIH) and the Centers for Disease Control and Prevention (CDC).24 The 2002 GAO report

states that:

[T]he agency continues to experience high turnover for reviewers because of the high

demand for regulatory review personnel in the pharmaceutical industry and the higher

salaries that experienced FDA reviewers can obtain in the private sector.... FDA officials

Ibid., pp. 21-23.

Congressional Research Service

The Food and Drug Administration: Budget and Statutory History, FY1980-FY2007

reported that to retain experienced staff with certain skills, they have increased the pay for

approximately 250 [product] reviewers. Specifically, FDA conducted studies of staff

turnover and found that toxicologists, pharmacologists, pharmacokinetists, and mathematical

statisticians were leaving FDA to work in private industry and academia for higher salaries.

Under [federal personnel] regulations, FDA is authorized to pay retention allowance of up to

10 percent of an employee’s basic pay to a group or category of employees in such

circumstances.25

The GAO report also found that “FDA reviewers, particularly those in CBER [Center for

Biologics Evaluation and Research], did not participate in training and professional development

activities ... to ensure that the agency meets PDUFA goals.”26 The 2006 IOM report commented

on the attrition of FDA personnel by stating that “although one explanation for the turnover is that

FDA staff leave for promising opportunities in industry ... it is possible that turnover is indicative

of a less-than-ideal organizational culture that requires attention.”27

A potential indicator of the difficulty FDA has in keeping experienced staff is the agency’s

issuance of retention bonuses to some employees. This practice is controversial and is under

investigation by the House Committee on Energy and Commerce:

The payments ... attracted bipartisan criticism from lawmakers ... [who] say that at the FDA

many of the bonuses went to the highest-paid officials rather than the scientists, inspectors

and doctors most at risk of jumping to the private sector. To critics, the payments bore little

relationship to the agency’s performance and reputation or to the likelihood that someone

might depart. Agency officials disagree and call the program a success.... In 2002, the FDA

lost 12 to 13 percent of its employees, while in 2006, with the bonus program in place, it lost

5 percent.... The bonuses—which are funded in part with fees paid by industry for product

reviews—bring no guarantee of retention.28

Comparison of FDA Budget with Other Agency Budgets

Figure 2 compares the funding, over time, for FDA, NIH, and CDC, the primary federal agencies

with public health duties. In FY1980, CDC and FDA had similar funding and NIH funding was

sevenfold greater than the other two agencies, as shown in Figure 2. Since FY1980, Congress has

increased the budget ninefold for CDC, almost fourfold for NIH and about twofold for FDA (in

FY2000 adjusted dollars). Other regulatory agencies similar to FDA, in that they are sciencebased and health-related, such as the Environmental Protection Agency (EPA), the Occupational

Safety and Health Administration (OSHA), and the Consumer Products Safety Commission

(CPSC), have received flat or declining budgets (adjusted for inflation) over this same time

period. 29

Ibid., pp. 21-22.

Ibid., p. 23.

IOM, The Future of Drug Safety, 2006, p. 81.

John Solomon and Marc Kaufman, “FDA’s Retention Bonuses Rise to the Top,” The Washington Post, August 2,

2007, p. A1.

For EPA, see Figure 1 in CRS Report RL32856, Environmental Protection Agency: Appropriations for FY2006, by

(name redacted) and (name redacted); for OSHA and CPSC, see budget data available on the OMB website at

http://www.whitehouse.gov/omb/budget/fy2008/db.html.

Congressional Research Service

The Food and Drug Administration: Budget and Statutory History, FY1980-FY2007

Figure 2. Budget Authority for FDA, CDC, and NIH

(Constant FY2000 $)

Source: Office of Management and Budget, Budget Authority file, Public Budget Database, Budget of the United

States Government, Fiscal Year 2008. Data available on the OMB website at http://www.whitehouse.gov/omb/

budget/fy2008/db.html.

Note: Does not include FDA offsetting collections (user fees), which have provided an additional 20% to 25% to

the FDA budget in recent years.

Concerns raised in the late 1970s about the cumulative effects of federal regulations on business

resulted in the substantial changes made by the Reagan Administration in the 1980s in “how

federal agencies develop and publish rules, and the degree to which federal regulations were

overseen by the Executive Office of the President.”30 The relatively flat funding experienced by

FDA and other regulatory agencies may in part be due to the Reagan regulatory reform efforts

combined with attempts to control federal spending and shrink the overall size of government.

Former FDA Commissioners, speaking on various public panels, have addressed FDA funding.31

In prepared testimony for a May 1, 2007 hearing before the House Committee on Oversight and

CRS Report RL32356, Federal Regulatory Reform: An Overview, by (name redacted).

Remarks by former FDA Commissioners Jane Henney, Donald Kennedy, and Frank Young at the Policy Workshop

on Strengthening the FDA, the SKAPP Project on Scientific Knowledge and Public Policy, George Washington

University School of Public Health and Health Services, Washington DC, February 21, 2007, transcript at

http://www.kaisernetwork.org/health_cast/uploaded_files/022107_gwu_workshop_transcript2.pdf; and Remarks by

former FDA Commissioners David Kessler and Mark McClellan at “Public Policy Implications of the Food and Drug

Administration Revitalization Act (FDARA),” Center for Congressional and Presidential Studies, American University

(continued...)

Congressional Research Service

The Food and Drug Administration: Budget and Statutory History, FY1980-FY2007

Government Reform, four former FDA Commissioners, Donald Kennedy, Frank Young, David

Kessler, and Jane Henney, all agreed that FDA is underfunded. Dr. Kessler made the following

observations on the funding Congress has provided for NIH, CDC, and FDA.

While Congress has attempted to provide resources for burgeoning public health needs on

other fronts, support for the FDA has faltered in comparison. In 1986, FDA’s budget was

comparable to 97% of the budget for CDC and 8% of the NIH’s budget. By [2006], it had

dropped to 28% of CDC’s budget and 5% of NIH’s. Significantly, while the NIH’s budget to

fund the research that leads to discoveries that ultimately fill the FDA’s drug pipeline has

doubled over the last five years, FDA’s budget has not grown.32

On this same point, former Acting FDA Commissioner Michael Friedman made the following

observations:

It is myopic to fund a minimal FDA when we have doubled the NIH budget roughly every

10 years for the past 40 years ... or when the pharmaceutical industry annually invests more

than $30 billion in research and development. Because regulatory review is the final

common pathway for all translational medicine, this lack of resources is rate-limiting. I

cannot predict everything that our citizens demand from FDA, but I am sure they are not

currently getting it. The issue is not what the FDA “needs;” it is rather what the American

public deserves.33

The 2006 IOM drug safety report notes that over the years various groups have examined the

same questions about the FDA and its budget and have made a variety of proposals and

recommendations to improve the agency that have not been fully implemented. The IOM report

goes on to state that:

A primary obstacle ... may be the chronic underfunding of core FDA activities owing to

inadequate attention to resource needs by Congress and the Office of Management and

Budget.34

Some Members of Congress also have expressed concern over the FDA funding level, and have

voiced their frustration at the inability to obtain clarification from the agency on the adequacy of

the FDA budget. A source of apparent frustration to those Members, including some who serve on

the appropriations subcommittees and have indicated their willingness to increase appropriations

to the agency, are the FDA officials who, year after year, neither ask for increased funding in their

testimony, nor, in response to Members’ questions, acknowledge what some observers perceive to

be the agency’s needs for additional resources. For example, in written testimony regarding the

FY2004 proposed budget, FDA Commissioner Mark McClellan stated:

We believe our budget request will allow FDA to fund ongoing operations at the current

level and also support more than 1,000 recently hired investigators and analytical staff to

fight counterrorism [sic].... The President’s 2004 Budget was developed within a framework

(...continued)

School of Public Affairs and FORA.tv, Washington DC, September 12, 2007.

David Kessler, “FDA’s Critical Mission and Challenges for the Future,” testimony before the U.S. House of

Representatives, Committee on Oversight and Government Reform, May 1, 2007, p. 2, at http://oversight.house.gov/

documents/20070501193354.pdf.

Friedman, “Strengthening the FDA,” 2002, p. 2332.

IOM, The Future of Drug Safety, p. 18.

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The Food and Drug Administration: Budget and Statutory History, FY1980-FY2007

that set a proposed total for discretionary spending in 2004, and each agency and program

request reflects the [George W. Bush] Administration’s relative priority for that operation,

activity or program.35

In contrast to the above testimony which occurred when he was Commissioner, former FDA

Commissioner Mark McClellan made the following statement at a March 2007 hearing of the

Senate Committee on Health, Education, Labor, and Pensions:

First, the FDA will need significantly greater appropriations to improve post-market safety.

The FDA is over-stretched, and a lack of trained staff and technical capabilities to perform

the oversight necessary on thousands of prescription drugs is an even more pressing issue

than providing the FDA with new regulatory authorities.36

Current FDA Commissioner Andrew von Eschenbach provided the following statement when

commenting on the adequacy of the FY2008 budget at a Senate Appropriations Committee

hearing:

These resources are an essential step in building a 21st century FDA that responds to the new

opportunities and new challenges of science and technology. Our budget allows FDA to

strengthen the tools we use to ensure the safety of foods, evaluate new products, and better

predict—earlier and more accurately—the safety and efficacy of drugs, biologics and

medical devices. With these resources, we will work to ensure that Americans enjoy the

benefits of personalized medicine, a safe and wholesome food supply, and the promise of a

better, healthier future.37

The IOM committee that worked on the 2006 drug safety report also was not able to ascertain the

agency’s funding requirements:

Convention dictates that federal agencies do not publicly articulate resource needs that differ

from those offered in the President’s budget, so the [IOM] committee was unable to

understand fully what ... FDA leadership estimate[s] is needed to meet current objectives, let

alone the expanded responsibilities the committee envisions for the future.38

In his May 1, 2007 testimony, former Commissioner Donald Kennedy confirmed this point:

I hope you and your staff will be diligent about pursuing FDA resource needs. But you may

have to rely on grizzled veterans like me, because budget authorities at HHS and OMB

specifically prohibit present officials in the agency from speaking out publicly about the

need for more funding.... [I]t is important that Americans know, when they hear FDA

Written testimony of Mark McClellan, Commissioner of the Food and Drug Administration, in U.S. Congress, House

Committee on Appropriations, Subcommittee on Agriculture, Rural Development, FDA, and Related Agencies,

FY2004 FDA Budget Request, hearing, 108th Cong., 1st sess., March 6, 2003, at http://www.fda.gov/ola/2003/

fy2004budget.html.

Testimony of Mark McClellan, former FDA Commissioner, in U.S. Congress, Senate Committee on Health,

Education, Labor and Pensions, Prescription Drug Safety and User Fees, hearing, 110th Cong., 1st sess., March 14,

2007.

Statement of Andrew von Eschenbach, Commissioner of the Food and Drug Administration, in U.S. Congress,

Senate Committee on Appropriations, Subcommittee on Agriculture, Rural Development, FDA, and Related Agencies,

hearing, 110th Cong., 1st sess., February 27, 2007, at http://www.fda.gov/ola/2007/budget0227.html.

Ibid., p. 199.

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The Food and Drug Administration: Budget and Statutory History, FY1980-FY2007

officials say they are satisfied with their budget allocations, that they have their fingers

crossed underneath the witness table.39

Like all federal agencies, FDA’s budget history reflects both Administration requests and

congressional decisions on appropriations. In general, previous Administrations have not argued

before Congress for increased FDA funding over the years. In some situations, however,

Congress has decided to grant additional funds to agencies above an Administration’s request. For

example, the relevant House and Senate appropriations bill reports demonstrate that Congress has

often chosen to increase NIH funding when an Administration has not requested additional

appropriations. Congress is supported and encouraged in its efforts to increase the NIH budget by

various health and research advocacy groups which promote their individual causes.

Some agencies are able to bypass budget adjustments made by HHS and OMB via alternative

mechanisms. For example, the National Cancer Institute (NCI) at NIH is mandated by the

National Cancer Act of 1971 (P.L. 92-218) “to prepare and submit, directly to the President for

review and transmittal to Congress, an annual budget estimate (including an estimate of the

number and type of personnel needs for the Institute) for the National Cancer Program, after

reasonable opportunity for comment (but without change) by the Secretary, the Director of NIH,

and the Institute’s advisory council.”40 The so-called NCI Bypass Budget received by Congress

describes the increase required to maintain NCI’s present level of operations and the increases

required to expand existing initiatives. 41 Similarly, CDC has prepared a “Professional Judgment”

budget in response to requests from a congressional appropriations committee. 42

A regulatory agency, such as the FDA, may be perceived as an impediment to achieving the goals

of advocacy groups concerned with the expeditious approval of new drugs or devices for the

treatment of specific diseases. However, when drug or device adverse events occur, there is

heightened concern about FDA’s approval process. In general, attention to FDA’s state of affairs

seems to be dependent on reaction to crisis. The public and Congress tend to focus on the agency

when its regulatory processes fail to meet their expectations. This phenomenon is perhaps best

exemplified by the thalidomide episode in 1962.43 However, even significant legislative solutions,

such as the Kefauver-Harris Drug Amendments of 1962 (which required demonstration of

effectiveness prior to drug approval), were not accompanied by an increase in funding for FDA.

In his history of FDA and its regulation of the pharmaceutical industry, Philip J. Hilts, referring to

passage of Kefauver-Harris, reported that:

Unfortunately, when Congress took this step forward, getting serious about science and

testing to protect the public, it did what it had often done before: it voted to give the agency

new duties and responsibilities while failing to provide the money to allow the agency to

Donald Kennedy, testimony before the U.S. House of Representatives, Committee on Oversight and Government

Reform, May 1, 2007, p. 4, at http://oversight.house.gov/documents/20070502110032.pdf.

PHS Act, Section 413(b)(9).

U.S. Department of Health and Human Services, National Institutes of Health, National Cancer Institute, The

Nation’s Investment in Cancer Research: A Plan and Budget Proposal for Fiscal Year 2008, October 2006, NIH

Publication Number 06-6090, p. 40, at http://plan2008.cancer.gov/pdf/nci_2008_plan.pdf.

Centers for Disease Control and Prevention, Professional Judgment for Fiscal Year 2008, April 20, 2007, at

http://www.fundcdc.org/documents/CDCFY2008PJ_000.pdf.

Philip J. Hilts, Protecting America’s Health: the FDA, Business, and One Hundred Years of Regulation, Alfred A.

Knopf, New York, 2003.

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The Food and Drug Administration: Budget and Statutory History, FY1980-FY2007

carry them out. The error would cause years of dissension and trouble, and would not be

remedied for three decades.44

Presumably, the remedy Hilts is referring to is PDUFA and the implementation of user fees by

FDA in 1993. Some critics argue that user fees have not solved FDA’s funding problems and have

led to additional complications for the agency.45 Critics also suggest that the way the agency has

been managed and the resource structure imposed by statute contribute to the agency’s perceived

problems in accomplishing its mission.

FDA Activity-Area Budgets

FDA is organized into six centers, which cover the broad activity areas for which the agency has

responsibility, and two offices that perform agency-wide functions.46 The traditional activity areas

are somewhat parallel to the current centers. FDA’s major activity areas are: Foods; Human

Drugs; Biologics; Animal Drugs and Feeds; and Medical Devices and Radiological Health. This

report focuses on the activity areas rather than the centers, to be consistent with the presentation

in the historical Justification documents. Center names and their activity area responsibilities

have changed over time to reflect shifts in agency organization, but the agency’s activity areas

have stayed fairly constant over the past 25 years.

Although FDA consistently reports its budget recommendations broken out by activity areas, it is

not possible, using the publicly available Justifications, to determine whether these categories

have always included the same activities. Therefore, as with other federal agencies, it is not

always possible to accurately compare categories of budget or staffing over long periods of time.

An example of this, as discussed below, is the changing placement of Biologics in the agency’s

budget. Biologics was encompassed for a time within the Human Drug budget, and FDA’s

Justifications provide no means of separating the two activities. This report contains the most

consistent accounting that was possible from the information provided in the FDA

Justifications.47 For further information on the difficulties in compiling a budget history of the

agency, and the steps taken to address those problems in this report, see the Methodology section

in the Appendix.

The Office of the Commissioner and the National Center for Toxicological Research do not have

direct regulatory responsibilities and, therefore, are only described briefly in this report. Their

funding and personnel are included, however, in the FDA totals. The Office of Regulatory Affairs

(ORA) conducts FDA’s compliance activities, including inspection and enforcement, across all

activity areas. The agency’s budget justification documents allocate ORA funding to each activity

area as “field activities.”

Ibid., p. 165.

Frank E. Young, testimony before the U.S. House of Representatives, Committee on Oversight and Government

Reform, May 1, 2007, p. 4, at http://oversight.house.gov/documents/20070501193917.pdf; and Rena Steinzor and

Margaret Clune, “The Hidden Lesson of the Vioxx Fiasco: Reviving a Hollow FDA,” Center for Progressive Reform,

October 2005, at http://www.progressivereform.org/articles/Vioxx_514.pdf.

The Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH),

Center for Drug Evaluation and Research (CDER), Center for Food Safety and Applied Nutrition (CFSAN), Center for

Veterinary Medicine (CVM), National Center for Toxicological Research (NCTR), Office of the Commissioner (OC)

and the Office of Regulatory Affairs (ORA). The organization tables of FDA overall and its components are available

at http://www.fda.gov/opacom/7org.html.

FDA cited constraints on its staff time and indicated that it would only be able to provide data for recent years.

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The Food and Drug Administration: Budget and Statutory History, FY1980-FY2007

Table 1. Summary of Increase in Total Budget and FTEs, FY1980 and FY2006

(Constant FY2000 $)

Activity Area

Food

Measure

FY1980

FY2006

Budget

$188,967,000

$376,262,000

99.1%

2,408

2,774

15.2%

$143,292,000

$436,454,000

204.6%

2,102

2,947

40.2%

$44,004,000

$169,562,000

285.3%

507

979

93.1%

$46,688,000

$83,914,000

79.7%

516

592

14.7%

$97,427,000

$218,732,000

124.5%

1,399

1,498

7.1%

$675,271,000

$1,597,508,000

136.6%

8,182

9,698

18.5%

FTEs

Human Drugs

Budget

FTEs

Budget

Biologics

FTEs

Animal Drugs & Feeds

Devices & Radiological Health

FDA Totala

Budget

FTEs

Budget

FTEs

Budget

FTEs

% Increase

Source: FDA Justification of Estimates for Appropriations Committees documents.

Note: Detailed unadjusted budget amounts and FTE numbers can be found in this report’s Appendix, Table

A-2, and Table A-3.

Activity area numbers do not add to FDA totals because not all FDA functions are listed in the table.

After adjusting for inflation, FDA’s total budget increased by 136.6% between FY1980 and

FY2006 (see Table 1). Over the same period, total FTEs increased by 18.5%. Each activity area

within the agency reflects a greater increase in budget than in FTEs during the period. As noted

above, tracking FTEs is typically an imperfect measure of changes in an agency’s level of effort

over time. 48 A variety of factors might account for the differing rates of growth of FDA’s budget

and staffing. A precise accounting of the possible causes of these differences was not available in

FDA budget Justifications.49 Further exploration of the reasons for the differing rates of growth in

budget and FTEs is, however, beyond the scope of this report.

Figure 3 compares the FDA budgets for FY1980 and FY2006, displaying the major activity area

budgets relative to each other and to the whole agency. The figure also illustrates the relative

proportions of the activity-area budgets that user fees finance. In FY2006, user fees comprised

41% of the Human Drugs budget, 30% of Biologics, 14% of Devices and Radiological Health,

8% of Animal Drugs and Feeds, and 0% of Foods. The proportion of the total FDA budget

provided in direct appropriations as budget authority was 96% in FY1980 and 80% in FY2006.

See discussion of FTEs beginning on p. 5.

The authors requested further information from FDA which, as of the date of this report, has not been provided.

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The Food and Drug Administration: Budget and Statutory History, FY1980-FY2007

Figure 3. FDA Budgets for FY1980 and FY2006, by Major Activity Area and Type of

Funding

Source: FDA Justification of Estimates for Appropriations Committees documents.

Notes: Total FDA budget without adjustment for inflation was $340 million in FY1980 and $1,863 million in

FY2006. “Animal Drugs” is Animal Drugs and Feeds, and “Devices” is Devices and Radiological Health.

Impact of New Statutory Authorities on FDA Budget

New statutory authorities, assigned to specific FDA activity areas, frequently mandate initiatives

without resources for implementation. The implementation of major new initiatives requires

adequate time and resources to meet congressional intent. Former FDA Commissioner Frank

Young indicated that, while he was Commissioner, there were “mandates for 22 new activities

without accompanying appropriations,” which he categorized as unfunded mandates. 50 He also

attested to the difficulty for the agency in the implementation of new statutory language. In the

case of implementing the Hatch-Waxman Act for the expeditious evaluation of generic drug

products, he stated the following:

[T]here were major problems in the development of procedures within FDA, inadequate

resources available for crafting the regulations, and difficulties in the implementation of the

initial ANDA [Abbreviated New Drug Application] processes. Similarly, there were

Frank E. Young, testimony before the U.S. House of Representatives, Committee on Oversight and Government

Reform, May 1, 2007, p. 6, at http://oversight.house.gov/documents/20070501193917.pdf.

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The Food and Drug Administration: Budget and Statutory History, FY1980-FY2007

substantial budgetary needs for adequate enforcement of procedures, for approval of

products developed by industry during the initial implementation of the act. The agency was

in uncharted water.51

Likewise, implementation of the FDA Modernization Act of 1997 (FDAMA), required the agency

to “develop 42 new regulations, 23 guidances and numerous reports and studies,” many within a

year.52 At the time, HHS Secretary Shalala commented on the complications and costs of carrying

out the effort, which she estimated to be $50 million.53

The $1.58 billion that FDA has collected in prescription drug user fees since FY1993 has helped

the agency improve the timeliness of its drug review process. These benefits may mask what

some FDA advocates see as PDUFA’s distorting effects on within-activity-area budgeting.

Congress included in PDUFA an important limitation, often referred to as a trigger, to ensure that

the user fees would supplement rather than supplant appropriated funds. To collect and spend the

drug user fees, FDA must maintain at least the same level of effort on activities related to human

drug review as it had before PDUFA. That limitation would not affect other parts of the FDA

budget if other funding were to keep pace with both inflation and the needs of the agency.

However, according to FDA documents and the observations of external experts, FDA’s financial

situation has changed over the 15 years since PDUFA began. FDA has had to use directly

appropriated funds to keep the PDUFA-related activities at least constant over time, thereby

diverting those funds from other uses. FDA financial reports, required under PDUFA, have

claimed that this unanticipated PDUFA effect has resulted in “an erosion of core FDA

programs.”54

FDA Regulatory Research

The research program at FDA provides scientific support for regulatory issues addressed by the

agency. Research has been a part of the agency almost from the time of its inception in 1906.55

All five FDA activity areas support research with Foods conducting the largest program in

FY2006, followed by Biologics, Devices and Radiological Health, Animal Drugs and Feeds, and

Human Drugs, which has a very small research program. Research performed in the five FDA

activity areas comprises about 50% of the FY2006 FDA research budget. Other entities within

FDA that perform research are the National Center for Toxicological Research (33%), Office of

Orphan Products (11%), Program Management (3%), and Buildings and Facilities (3%).56 Figure

Ibid.

Jill Wechsler, “The ‘R’ in CDER and CBER,” Pharmaceutical Technology, April 1998, p. 14.

Ibid.

See discussion of “triggers” in “Human Drugs“ section of this report, as well as the FDA White Paper Prescription

Drug User Fee Act (PDUFA): Adding Resources and Improving Performance in FDA Review of New Drug

Applications, at http://www.fda.gov/oc/pdufa/whitepaper11-10/whitepaper11-10.html, and the FY2001 PDUFA

Financial Report, at http://www.fda.gov/oc/pdufa/finreport2001/financial-fy2001.htm, and the FY2000 PDUFA

Financial Report, at http://www.fda.gov/cder/pdufa/financial-fy2000.htm, and the FY1999 PDUFA Financial Report,

at http://www.fda.gov/oc/oms/ofm/accounting/pdufa/1999Report.htm.

The Bureau of Chemistry established a Food Research Laboratory shortly after it was created within the Department

of Agriculture. See the Science Board Subcommittee on FDA Research, “Recommendations to the Science Board of

the Food and Drug Administration,” Final Draft Report, March 13, 1997, Appendix D, “An Abbreviated History of at

Least Four Decades of Efforts to Upgrade the Quality of Science in the FDA,” at http://www.cfsan.fda.gov/~frf/

sxsbrd.html.

FDA research budget data from RAND Corporation RaDiUS database, November 7, 2007. RaDiUS, which stands

(continued...)

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4 shows the amount of support for research within the five FDA activity areas from FY1993

through FY2008.

Figure 4. FDA Research in Five Activity Areas (Constant FY2000 $)

$180,000

Dollars (in thousands)

$160,000

$140,000

$120,000

$100,000

$80,000

$60,000

$40,000

$20,000

1993

1995

1997

1999

2001

2003

2005

2007

Fiscal Year

Foods

Human Drugs

Biologics

Animal Drugs

Devices

Sources: FDA research budget data was provided by Donna Fossum of the RAND Corporation using the

RaDiUS database on November 7, 2007. Data collection for RaDiUS began with FY1993. FDA data collected for

FY2006 through FY2008 were received by RAND from FDA Office of Budget Formulation and Presentation

(OBFP) via Edward King, HHS Office of the Assistant Secretary for Management and Budget, in March 2007.

Amounts for Foods for FY2006 through FY2008 were adjusted per personal communication with Robert Miller,

FDA-OBFP, on November 19, 2007.

The appropriate role of research in fulfilling FDA’s mandate to license and approve safe and

effective products has been a contentious issue at least since the early 1970s.57 At the request of

former Deputy Commissioner for Operations Michael Friedman, a review of FDA research was

conducted in 1996 by a subcommittee of the FDA Science Board. The Chairman of the

subcommittee, Dr. David Korn, stated that “Congress has not been asked to support research

explicitly; [research] has always been buried in the agency’s budget.”58 Dr. Korn suggested that it

would require a major educational effort by industry to convince Congress that research is

essential to the function of FDA because “industry is, in a sense, the FDA’s customer,” and “if the

(...continued)

for “Research and Development in the United States,” tracked all research and development activities and resources of

the government from FY1993 through FY2008. The contract for RaDiUS operations and maintenance has ended and

the database is no longer available. See https://radius.rand.org/.

Charles Marwick, “FDA Funding Problems Imperil Safety of Biological Products in the United States,” Journal of

the American Medical Association, March 25, 1998, pp. 899-901.

Ibid., p. 900.

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The Food and Drug Administration: Budget and Statutory History, FY1980-FY2007

thrust came from industry, it would carry weight with the Congress.”59 The final report of the

subcommittee, dated March 1997, stated that:

The decreasing agency [research] budget is of overarching concern. Although there is

general appreciation of the fact that in times of constrained resources the agency must take

particular care that its mandated regulatory responsibilities are competently discharged, there

is a widely held perception among agency scientists that the research programs do not have

strong advocacy at the highest levels of agency leadership and are front-line targets for

curtailment or elimination as discretionary resources decline. The subcommittee believes

strongly that starving the agency’s base of intramural scientific expertise must inevitably

compromise the quality of review and regulatory activities.60

The role of FDA research and the level of resources required for its support continues to be

identified as an issue for the agency. During the May 1, 2007, congressional hearing, the former

Commissioners specified the lack of financial support for the research program at FDA as a major

concern. Former commissioner Frank Young stated that “research at CBER has been eviscerated

through a recent reorganization and is almost non-existent in CDER. To maintain the expertise

necessary for expeditious but highly competent decisions on new breakthrough products,... it is

essential to have a well trained scientific staff that is given the time to not only maintain scientific

expertise but to pursue career development in their chosen field of science.”61 On this same point,

former commissioner David Kessler stated that:

The erosion of funding has struck hard at the Agency’s ability to support its proud tradition

of groundbreaking research in regulatory science. While in the past, the Agency led the way

in developing new scientific paradigms for approving biologics and assessing food

contaminants—to the benefit of both industry and consumers—resources for FDA to lend its

intellectual firepower to addressing key regulatory questions are increasingly scarce.62

FDA Science Board Report

A report that assessed “whether science and technology at the FDA can support current and future

regulatory needs” was released in November 2007.63 The report was requested by FDA

Commissioner Andrew von Eschenbach in December 2006 and was prepared by the FDA Science

Board, a group of independent advisors. It found that FDA “suffers from serious scientific

deficiencies and is not positioned to meet current or emerging regulatory responsibilities.”64 The

report points at two reasons for the deficiency: the demands on FDA have soared, and resources

have not increased in proportion to the demands. It states that “due to constrained resources and

Ibid., p. 901.

The Science Board Subcommittee on FDA Research, “Recommendations to the Science Board of the Food and Drug

Administration,” Final Draft Report, March 13, 1997, at http://www.cfsan.fda.gov/~frf/sxsbr.html.

Frank E. Young, testimony before the U.S. House of Representatives, Committee on Oversight and Government

Reform, May 1, 2007, p. 3, at http://oversight.house.gov/documents/20070501193917.pdf.

David Kessler, “FDA’s Critical Mission and Challenges for the Future,” testimony before the U.S. House of

Representatives, Committee on Oversight and Government Reform, May 1, 2007, p. 3, at http://oversight.house.gov/

documents/20070501193354.pdf.

FDA Science Board, Subcommittee on Science and Technology, FDA Science and Mission at Risk, November 2007,

at http://www.fda.gov/ohrms/dockets/ac/07/briefing/20074329b_02_01_FDA%20Report%20on%20Science%20and%20Technology.pdf.

Ibid., p. 2.

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lack of adequate staff, FDA is engaged in reactive regulatory priority setting or a fire-fighting

regulatory posture instead of pursuing a culture of proactive regulatory science.”65

The FDA Science Board was specifically asked to review the status of science and technology at

FDA, and not to evaluate the available resources. However, the report states that the status of

science and technology was “so intertwined with two decades of inadequate funding that it was

impossible to assess technology without also assessing resources.”66 The Science Board also

looked at reports on FDA issued by previous review committees, each given a similar charge over

the past 50 years. It found that the concerns outlined in past reports were the same as those in the

present and that FDA has consistently been unable to implement the needed changes. An advisor

to the Science Board, Garret A. FitzGerald, blamed a faction of “congressional majorities and

presidential administrations that has serially stripped the agency of assets.”67

Representative Rosa DeLauro, who in the 110th Congress was appointed chair of the House

Appropriations Subcommittee on Agriculture, Rural Development, FDA, and Related Agencies,

stated that the November 2007 report confirms facts that she believes have been apparent to

Congress and FDA for some time. “[S]cience at the FDA is deteriorating and the agency lacks the

planning, management structure, and resources to restore their scientific capabilities.”68 She

further states that although her subcommittee is working on providing additional funds for the

agency, “money alone will not resolve the problems at FDA—these additional funds need to be

supported by an adequate management structure and a sound plan on how these funds will be

used to ensure that they are not wasted.”69

The FDA Science Board report concluded that “FDA can no longer fulfill its mission without

substantial and sustained additional appropriations,” and that the agency is in danger of “losing its

remaining dedicated staff” if the “chronic underfunding of the agency” is “not addressed

immediately.”70 The report stated that there is “insufficient investment in professional

development [for FDA staff], which means that the workforce does not keep up with scientific

advances.... Inadequately trained scientists are generally risk-averse, and tend to give no decision,

a slow decision or, even worse, the wrong decision on regulatory approval or disapproval.”71 The

report also concluded that funding increases recommended by other groups, such as IOM and the

Coalition for a Stronger FDA, are insufficient to allow all the changes necessary for the agency to

fulfill its mission. “Without a substantial increase in resources, the agency is powerless to

improve its performance, will fall further behind, and will be unable to meet either the mandates

of Congress or the expectations of the American public. This will damage not only the health of

the population of the U.S., but also the health of the economy.”72

Ibid., p. 4.

Ibid., p. 6.

Gardiner Harris, “Advisers Say FDA’s Flaws Put Lives at Risk,” The New York Times, December 1, 2007.

DeLauro Statement on FDA Science Board Report, December 3, 2007, at

http://delauro.house.gov/release.cfm?id=697.

Ibid.

FDA Science Board, Subcommittee on Science and Technology, FDA Science and Mission at Risk, p. 7.

Ibid., pp. 4-5.

Ibid., p. 8.

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The Food and Drug Administration: Budget and Statutory History, FY1980-FY2007

Major Activity Areas: Budget and FTEs

The next sections of this report provide, for each FDA major activity area, a brief description of

the statutory responsibilities in 1980 and an overview of how the agency’s responsibilities have

expanded over the years up through 2007. Juxtaposed with the presentation of increasing

responsibilities for the activity area is a presentation and analysis of the budget and number of

FTEs for the period FY1980 through FY2007.73 The descriptions of FDA’s responsibilities and

resources provide a background against which to examine FDA funding needs. Other CRS reports

examine the particulars of many FDA activities and their funding.74

Foods75

FDA is responsible for promoting and protecting the public’s health in part by ensuring that the

food supply is safe, sanitary, wholesome, and accurately labeled. The agency regulates all foods,

except for meat and poultry which are regulated by the U.S. Department of Agriculture

(USDA). 76 It is also responsible for assuring that cosmetic products are safe and properly labeled.

The agency regulated $417 billion worth of domestic food, $49 billion worth of imported food,

and $60 billion worth of cosmetics in 2001.77 These numbers encompass the economic activity of

about 50,000 food establishments (manufacturers, processors, and food warehouses) and 3,500

cosmetic firms. 78 Not included in these figures are the roughly 600,000 restaurants and

institutional food service establishments and 235,000 supermarkets, grocery stores, and other

food outlets that are regulated by state and local authorities, for which FDA provides guidance,

model codes, and other technical assistance.

Although FDA is responsible for ensuring the safety of the food supply, its role is primarily

reactive since most foods and their ingredients are not subject to prior approval or even review

before they enter interstate commerce. The agency does have responsibility over some product

ingredients that require premarket approval, such as food and color additives. FDA also performs

postmarket monitoring of food labels and investigates food safety problems that arise. The

agency’s surveillance program tests food samples to determine if pesticide residues or heavy

metals are present in unacceptable amounts. It also sets standards for label information to assist

consumers in determining the ingredient and nutrient content of the foods that they are

purchasing. The agency’s current activities related to foods are primarily conducted by the Center

for Food Safety and Applied Nutrition (CFSAN).

The Pure Food and Drug Act of 1906 gave the agency its initial authority to prohibit the interstate

commerce of adulterated or misbranded food products, along with the authority to assess criminal

penalties for violations and seize offending products. The Federal Food, Drug, and Cosmetic Act

Budget size varies across the activity areas within FDA. The budget range shown in each figure reflects a scale

appropriate to allow clear illustrations of the within-activity area budget variation across years.

See listings of CRS products relating to FDA-regulated foods, human drugs, biologics, devices, animal drugs, and

cross-cutting issues at http://apps.crs.gov/cli/cli.aspx?PRDS_CLI_ITEM_ID=2678 and http://apps.crs.gov/cli/

cli.aspx?PRDS_CLI_ITEM_ID=2621.

This section was prepared by (name redacted), Specialist in Food Safety and Nutrition.

CRS Report RS22600, The Federal Food Safety System: A Primer, by (name redacted) and (name redacted).

FDA Science Board, Subcommittee on Science and Technology, FDA Science and Mission at Risk, 2007, p. 11.

See http://www.cfsan.fda.gov/~lrd/cfsan4.html.

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of 1938 (FFDCA), building on the provisions of the 1906 Act, required the agency to promulgate

definitions and standards for foods and informative labeling. It also prohibited false advertising

and the addition of substances that would render the food adulterated. Over the years, several

amendments to the act added authorities that required FDA to establish (1) tolerances (safe levels)

for pesticides on agricultural commodities; (2) premarket approval systems for food and color

additives, and packaging substances; (3) rules for labels to facilitate price comparisons; and (4)

rules to assure that packages contain the amount of product the label claims.

By FY2007, Congress had added a number of new FDA authorities to those that existed before

FY1980 (see Table 2). Under the Infant Formula Act of 1980 (P.L. 96-359) FDA established

requirements for the manufacturing, labeling, and nutrient standards for these products. The

Nutrition Labeling and Education Act of 1990 (NLEA, P.L. 101-535) provided authority for (1)

mandating nutrition labels on most food products, and (2) following the agency’s review,

allowing nutrient content and health claims. In addition, NLEA preempted most state and local

requirements for labeling, giving FDA responsibility for regulating all aspects of nutrition

labeling information. NLEA resulted in the promulgation of a significant number of new

regulations and revisions of old rules for consistency with the new authorities. The Dietary

Supplement Health and Education Act of 1994 (DSHEA, P.L. 103-417), provided specific

authority for the regulation of supplements and placed the burden of proof on the agency to

demonstrate that a supplement already on the market was unsafe and needed to be removed.

The Food Quality Protection Act of 1996 (P.L. 104-170) established a single health-based

standard for pesticides in all foods and provided special safety provisions for infants and children.

After FFDCA provisions were amended by the FQPA of 1996, FDA continued to monitor

pesticide residue levels in food in interstate commerce (which it does through its total diet study)

and enforce tolerances through its food inspection programs, while EPA remains the lead agency

on setting tolerances and related issues. The Food and Drug Administration Modernization Act of

1997 (P.L. 105-115) eliminated premarket approval of food-contact substances (i.e., packaging

materials), replacing it with a notification process, along with expanding procedures for FDA

authorization of health and nutrient content claims under the NLEA statutory standard.

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (P.L. 107188) required all domestic and foreign facilities that manufacture, process, pack, or hold food for

U.S. consumption to register with FDA and maintain records for agency inspection. The act also

required prior notice to FDA of products being imported into the United States and provided the

agency with administrative detention authority and penalties.

The Food Allergen Labeling and Consumer Protection Act of 2004 (P.L. 108-282) required that a

specific statement appear on a food label when any of the most common allergens are present in a

food. In 2006, the Dietary Supplement and Nonprescription Drug Consumer Protection Act (P.L.

109-462) was enacted, which created a system for reporting to FDA any serious adverse events

associated with the use of a dietary supplement, as well as record keeping and inspection

authority that may be necessary in cases of a reported adverse event.

Food safety provisions within the Food and Drug Administration Amendments Act of 2007 (P.L.

110-85) required the creation of a registry for reportable information on foods with safety

problems. It also allowed for the identification of the supply chain of the questionable food item.

Adjusted for inflation, FDA’s foods budget doubled between FY1980 and FY2007; the number of

FTEs increased by 15.2% during the same period. Despite substantial increases in statutory

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authority during the period, FDA’s Foods activity did not gain the authority to collect user fees,

unlike the other activity areas (discussed below).

Table 2. Foods Statutory Authorities in 1980 and 2007

Authorities in 1980

Prohibited interstate commerce in adulterated or misbranded products; provided criminal penalties for violations and authorized

seizures of offending products (P.L. 59-384).

Defined filled milk and considered it adulterated, injurious to health and a fraud (P.L. 67-513).

Required the issuing of valid permits for importation of milk and cream (P.L. 67-625).

Required definitions and standards for foods and informative labeling; prohibited false advertising and the addition of substances that

rendered the food adulterated (P.L. 75-717).

Established premarket approval system for new food additive and packaging substances (P.L. 85-929).

Established premarket approval system for colors used in food, drugs, and cosmetics (P.L. 86-618).

Required rules to prevent non-functional fill of packages and to require legible, prominent label statements for net quantity of

contents (P.L. 89-755).

Required inspection of egg products and established uniform standards for grading eggs (P.L. 91-597).

Limited authority to regulate the composition and promotion of dietary supplements (P.L. 94-278).

Authorities Added Between 1980 and 2007

Required rules for reporting, quality control, recall, exemption labeling and nutrient content for infant formulas; amended for

additional recall, microbiological testing and record retention requirements (P.L. 96-359).

Required assistance with food transportation inspections (P.L. 101-500).

Mandated nutrition labeling and review of nutrient content and health claims; preempted state and local requirements, transferring

to FDA the regulation of all aspects of nutrition labeling information (P.L. 101-535).

Provided specific authority to regulate dietary supplements and placed the burden of proof for safety on FDA for products already

on the market; required rules for notification for statements of nutritional support, ingredient and nutrition information, petition

process and review of new dietary ingredients, and good manufacturing practices (P.L. 103-417).

Required a single health-based standard for all pesticides in raw and processed foods; provided special pesticide safety standards for

infants and children; limited consideration of benefits and allowed civil penalties for tolerance violations; required tolerance levels

reevaluation in a decade; required endocrine testing, the right to know, and national uniformity of tolerances. Required FDA to

monitor pesticide residue levels on foods it regulated in interstate commerce and enforce tolerance levels through its inspection

programs (P.L. 104-170).

Eliminated premarket approval of food contact substances and substituted a notification process contingent on funding to cover

FDA’s cost; expanded procedures for authorizing health and nutrient content claims without reducing the statutory standards (P.L.

105-115).

Required all domestic and foreign facilities that manufacture, process, pack or hold food for U.S. consumption to register and

maintain records for inspection for any product believed to be adulterated; required prior notice of products being imported into

the United States; provided administrative detention authority and penalties for credible evidence that a product presents a threat of

serious adverse health consequences or death to humans or animals (P.L. 107-188).

Required a specific statement about most frequent allergens to appear on the label when any of those allergens are present in a food

(P.L. 108-282).

Reclassified as controlled substances any product containing an anabolic steroid or a precursor that would be converted to a steroid

in the body (P.L. 108-358).

Required the reporting to FDA of any serious adverse events that result from the use of a dietary supplement or nonprescription

drug; provided record keeping requirements and inspection authority needed for an investigation (P.L. 109-462).

Required the creation of a registry for reportable information on foods with safety problems that allows for identification of the

supply chain of the reportable food (P.L. 110-85).

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In Figure 5, changes in the foods budget and FTEs reflect certain events and policy initiatives

during the 28-year period. The budget was relatively flat through the 1980s with requests

primarily for mandatory costs and no program increases. The increase in budget and FTEs in the

early 1990s reflect the considerable amount of work required to implement NLEA and the

simultaneous CFSAN reorganization. Food safety activities also contributed to the modest

increase in FTEs and funding. The subsequent drop off of FTEs from FY1992 to FY1997

represents both deficit reduction efforts and a shift in FTEs to elsewhere in the agency as noted in

the 2002 GAO report. The new CFSAN building opened in College Park, MD, in 2001;

construction costs were part of the budget increases from 1997 until 2001. Increases in both

funding and FTEs in the late 1990s also signaled President Clinton’s food safety initiative.

Increases in the FY2002 budget and FY2003 FTEs represent increased agency attention to the

food supply following the domestic terrorist attacks and subsequent passage of the Public Health

Security and Bioterrorism Preparedness and Response Act of 2002. However, the increases did

not continue. The foods budget has remained flat, while the number of FTEs has decreased since

FY2002. Another reorganization of the foods portion of the agency occurred after 9/11 as a result

of a reordering of the Center’s work and priorities. Recent concerns about food safety problems

have drawn attention to both the foods budget and FTEs.79

For more information, CRS Report RS22779, Food Safety: Provisions in the Food and Drug Administration

Amendments Act of 2007, by (name redacted).

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Figure 5. Foods: Budget and FTEs(Constant FY2000 $)

Sources: For FY1980-FY2006, FDA Justification of Estimates for Appropriations Committees documents. FY2007

FTE data are based on an interim continuing resolution used in the FY2008 Justification and therefore do not

reflect final action by Congress. FY2007 budget data reflect the Operating Plan developed after passage of P.L.

110-5, Revised Continuing Appropriations Resolution, 2007.

Notes: Total FTEs = Budget Authority FTEs. Program Level $ = Budget Authority $.

Human Drugs80

No manufacturer may offer a prescription or over-the-counter drug for sale in the United States

without first obtaining FDA’s approval. The agency’s Center for Drug Evaluation and Research

(CDER) works with a manufacturer throughout the application process, from permitting human

clinical trials of an Investigational New Drug (IND), to evaluating for evidence of safety and

effectiveness the data from those trials that are part of a New Drug Application (NDA). Up to a

drug’s approval, CDER wields tremendous influence, as the law authorizes, on required studies

for the decision to grant marketing approval (hence, known as “premarket approval” or

“premarket review”), wording and layout of materials for the prescribing clinician and the patient,

and other aspects of the drug’s labeling.

Once a drug is on the market—a period known as both “postmarket” and “postapproval”—FDA

continues its activities to ensure the product’s safety and effectiveness, although the law does not

This section was prepared by (name redacted), Specialist in Drug Safety and Effectiveness.

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provide the agency with postapproval authority equivalent to its preapproval function. FDA staff

examine the results of studies conducted and submitted by manufacturers; review adverse event

reports from manufacturers, clinicians, and consumers; follow the scientific literature regarding

other drugs with similar mechanisms of action; and review labeling, packaging, and promotional

items to both consumers and clinicians. CDER staff also analyze data that the manufacturer

submits and look for trends in large databases of pharmaceutical use. 81

Figure 6 illustrates the resource history of the FDA Human Drugs program from FY1980 through

FY2007. Between FY1980 and FY2007, the total inflation-adjusted funding available for FDA

human drug activities increased 234% (that is, it more than tripled) and the number of FTEs

increased 34%.82

Figure 6. Human Drugs: Budget and FTEs (Constant FY2000 $)

Sources: For FY1980-FY2006, FDA Justification of Estimates for Appropriations Committees documents. FY2007

FTE data are based on an interim continuing resolution used in the FY2008 Justification and therefore do not

reflect final action by Congress. FY2007 budget data reflect the Operating Plan developed after passage of P.L.

110-5, Revised Continuing Appropriations Resolution, 2007.

Notes: From FY1983 through FY1987, the appropriations acts and the FDA-produced budget justifications

included funding for biologics activities in the human drug activities totals. Therefore, Figure 6 shows a peak in

those years and Figure 7 shows a concomitant trough for biologics. Total FTEs = Budget Authority FTEs + User

Fee FTEs. Program Level $ = Budget Authority $ + User Fees $.

For further information, see CRS Report RL32797, Drug Safety and Effectiveness: Issues and Action Options After

FDA Approval, by (name redacted).

Table A-2 in the Appendix displays the actual numbers (not adjusted for inflation). Using the unadjusted numbers,

FDA’s budget increased almost eightfold (690%) between FY1980 and FY2007. When the dollar figures are adjusted

to indicate comparable purchasing value, the increase diminishes to more than threefold (234%).

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The Food and Drug Administration: Budget and Statutory History, FY1980-FY2007

Beginning in FY1994, user fees have made up an increasing proportion of FDA’s budget for

human drug activities. While total funding has increased over the period, this has been entirely

due to the increase in user fees. Congressional appropriations have remained essentially flat.

Separating FTEs by funding source shows that the overall increase in personnel comes solely

from the user fees first collected in FY1993 and that the overall increase in FTEs obscures a 19%

decrease in congressionally funded (budget authority) personnel from FY1992 to FY2007.

The 1992 Prescription Drug User Fee Act, in providing FDA with an additional source of

funding, explicitly stated that the funds were to supplement, not supplant congressional

appropriations. The law included complex formulas, known as “triggers,” to enforce that goal.

FDA may collect and use fees only if the direct appropriations for the activities involved in the

review of human drug applications and for FDA activities overall remain funded at a level at least

equal to the pre-PDUFA budget, adjusted for inflation as specified in the statute.83

These triggers, in particular, and the relative contributions of appropriations and user fees to

FDA’s budget for human drugs have implications for budget planning both within the human

drugs activity area and in agency-level decisions across all activities.

The drug-related tasks for which FDA is responsible have evolved along with the social,

economic, scientific, and technologic developments in the United States. Even before there was a

Bureau of Chemistry in the Department of Agriculture (established in 1862, the ancestral origin

of the current FDA), Congress passed legislation to “prevent the importation of adulterated and

spurious drugs and medicines.” The 1906 Food and Drugs Act heralded the future influence of the

federal government on drug (and food) regulation to protect the public’s health. Many laws

followed (see brief descriptions in the Appendix, Table A-4). Among the most significant are:

the 1938 FFDCA, which required that drugs be safe; and the 1962 Kefauver-Harris Amendments

to the FFDCA, which required that drugs also be effective.

Subsequent laws addressed many issues for FDA, such as aiming to boost pharmaceutical

research and development; to speed the approval of new medicines, including by supplementing

FDA resources with user fee revenue; and to encourage research in pediatric drugs.84 Between

FY1980 and FY2007, Congress added to FDA’s responsibilities new areas (or expanded existing

ones) that involved scientific, legal, and enforcement expertise (see Table 3). Most recently, the

FDA Amendments Act of 2007 (P.L. 110-85) amended dozens of FFDCA sections. These

included human drugs provisions to reauthorize certain programs (such as the assessment,

collection, and use of prescription drug user fees); to enhance FDA’s authority in ensuring safety

and effectiveness over a product’s life (both pre- and postapproval). It required the Secretary to

maintain an Internet website with extensive drug safety information. New authorities include civil

monetary penalties for failure to comply with certain postmarket study, labeling, and television

advertisement requirements; mandates and incentives for pediatric drug research and labeling;

and requirements for making available to the public material such as minutes of agency-industry

performance goal negotiations, pediatric assessment findings and reviews, reviews of adverse

event reports, and advisory committee recommendations on action.

For further information, see CRS Report RL33914, The Prescription Drug User Fee Act (PDUFA): History,

Reauthorization in 2007, and Effect on FDA, by (name redacted).

For further information, see CRS Report RL33986, FDA’s Authority to Ensure That Drugs Prescribed to Children

Are Safe and Effective, by (name redacted).

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Table 3. Human Drugs Statutory Authorities in 1980 and 2007

Authorities in 1980

Inspect drugs from abroad for quality, purity, and fitness for medical purposes (30th Congress; predates use of the

current public law numbering format).

Regulate interstate commerce in food, drink, and drug products; prohibit adulteration and misbranding (P.L. 59-384),

including false statements of curative or therapeutic effect (P.L. 62-301).

Review evidence of safety (P.L. 75-717) and effectiveness (P.L. 87-781) before approving a drug for interstate

commerce.

Require records of shipments; inspect manufacturing, processing, packing, or holding facilities, including equipment,

materials, containers, and labeling (P.L. 75-717, expanded by P.L. 83-217).

Certify batches of color additives (P.L. 75-717); promulgate regulations for the listing of color additives in or on drugs

(or other FDA-regulated products) based on conditions, uses, and labeling to assure safe use (P.L. 86-618).

Enforce enhanced labeling and packaging requirements (P.L. 75-717).

Test and certify each batch of insulin (P.L. 77-366) and penicillin (P.L. 79-139) for strength, quality, and purity;

promulgate regulations covering, among other things, standards and tests.

Regulate certain drugs as prescription-only (P.L. 82-215).

Regulate prescription drug advertising (P.L. 87-781).

Regulate all antibiotics (P.L. 87-781).

Enforce enhanced regulations covering manufacture, recordkeeping, inspections, prescription refills, of depressant and

stimulant drugs; authorized to appoint expert advisory committees (P.L. 89-74).

Enforce enhanced labeling requirements (P.L. 89-755).

Notify Attorney General when a submitted new drug application involves a drug with an abuse potential (P.L. 91-513).

Authorities Added Between 1980 and 2007

Provide incentives for pharmaceutical manufacturers to develop drugs, biotechnology products, and medical devices

for the treatment of rare diseases and conditions (P.L. 97-414).

Investigate tampering with packaged consumer products (P.L. 98-127).

Review generic drug applications (P.L. 98-417).

Promulgate and enforce enhanced regulations on the distribution of drug samples (P.L. 100-293, expanded by P.L.

102-282).

Assess and collect fees from the pharmaceutical manufacturers and use the resulting revenue to support its review of

new drug applications (P.L. 102-571, P.L. 105-115, P.L. 107-188, P.L. 110-85).

Establish fast track approval process for drugs that would treat life-threatening conditions (P.L. 105-115).

Streamline the drug review process and provide a means for resolving controversial scientific issues (P.L. 105-115).

Enforce refined requirements regarding the dissemination of information about “off-label” uses of drugs or devices

not yet approved by the FDA, patient access to investigational therapies, international harmonization and national

uniformity in the regulation of nonprescription drugs and cosmetics (P.L. 105-115).

Conduct regulatory functions under a mission statement that will obligate it to maintain a public health protection

role while seeking to expedite the marketing of regulated products (P.L. 105-115).

Grant a manufacturer an additional six months of marketing exclusivity in exchange for completing FDA-requested

studies of use in children (P.L. 105-115; expanded by P.L. 107-109, P.L. 110-85).

Establish program allowing pharmacists and drug wholesalers to import lower-priced prescription drugs from specific

countries. [Not implemented due to trigger requirement.] (P.L. 106-387, P.L. 108-173).

Require a pediatric assessment of safety and effectiveness as part of an application to market a new active ingredient,

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new indication, new dosage form, new dosing regimen, or new route of administration for a drug or biologic, or, if

the Secretary considers it necessary, for an approved drug or licensed biologic (P.L. 108-155, expanded by P.L. 11085).

Study the use of technologies to provide prescription drug information to the blind and visually impaired (P.L. 108173).

Expedite review of countermeasures to chemical, biological, and nuclear agents that may be used in a terrorist attack

(P.L. 108-276).

Biologics85

Biologics are medical preparations made from living organisms. Examples of such products

include traditional biologics (such as vaccines, blood, blood products, antitoxins, and

allergenics86) and human therapeutic agents produced by the biotechnology industry (such as

insulin, interferon, growth hormone, and epoetin). FDA ensures the purity and effectiveness of

biologics by (1) issuing a license for each new product that is shown to be safe, pure, and potent

and (2) inspecting manufacturing facilities to assure the product continues to be safe, pure, and

potent. Unlike most chemically synthesized drugs (e.g., aspirin) with a known structure, biologics

are often complex mixtures that are not easily identified or characterized. Biologics might also be

living entities, such as cells and tissues. Biologics may be isolated from a variety of natural

sources (human, animal, or microorganism) or may be produced by biotechnology methods and

other cutting-edge technologies. FDA is also responsible for the safety of the nation’s blood

supply and routinely examines blood bank operations for record keeping and testing of donations

for contaminants.

Regulatory responsibility for biologics was first delegated in the early 1900s to the Hygienic

Laboratory, a precursor of the National Institutes of Health (NIH). 87 In 1972, regulatory authority

for biologics was transferred from the NIH Division of Biological Standards to the FDA Bureau

of Biologics. 88 During the early 1980s, the FDA merged the Bureau of Drugs and the Bureau of

Biologics to form the National Center for Drugs and Biologics. In 1984, all of the “National

Centers” within FDA were redesignated simply as “Centers.” In 1987, the FDA’s Center for

Drugs and Biologics was split into the Center for Drug Evaluation and Research (CDER) and the

Center for Biologics Evaluation and Research (CBER). CBER continues to use NIH facilities and

buildings until the expected move in 2012 to the new FDA headquarters in White Oak, MD.

Because biotechnology products frequently cross the conventional boundaries between biologics,

drugs, and devices, determining the jurisdictional status of these new products has been difficult

for both the FDA and industry. Some products have had characteristics that met multiple statutory

and scientific definitions. In 1991, the FDA published an Intercenter Agreement between CBER

and CDER. In general, the agreement stated that traditional biologics as well as most

biotechnology products, would be regulated by CBER.89 In 2002, however, the FDA announced

This section was prepared by (name redacted), Specialist in Biomedical Policy.

Allergenics are extracts used to diagnose and treat allergic reactions such as hay fever.

The NIH Almanac—Historical Data: Chronology of Events, at http://www.nih.gov/about/almanac/historical/

chronology_of_events.htm.

Donna Hamilton, “A Brief History of the Center for Drug Evaluation and Research,” FDA History Office, November

1997, at http://www.fda.gov/cder/about/history/Histext.htm.

Except for a small set of biologics (hormones, such as insulin, human growth hormone, and a few medical enzymes)

that would continue to be regulated by CDER. These biologics have historically been regulated as drugs under the

(continued...)

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its intention to reorganize review responsibilities, consolidating review of new pharmaceutical

products under CDER; CBER retains review responsibility for vaccines, blood safety, gene

therapy, and tissue transplantation. 90 On June 30, 2003, responsibility for most therapeutic

biologics was transferred from CBER to CDER.91 Remaining at CBER are traditional biologics

such as vaccines, allergenic products, antitoxins, antivenins, venoms, and blood and blood

products, including recombinant versions of plasma derivatives (clotting factors produced via

biotechnology).

Figure 7 shows the total FDA budget for Biologics, composed of budget authority and user fees,

for FY1980 through FY2007, adjusted to FY2000 dollars. It also provides FTE data over the

same years: FTEs funded by budget authority; and total FTEs funded at program level (budget

authority plus user fees). The impact on funding and FTEs of the FDA reorganization in the 1980s

can be clearly seen in Figure 7. Although budget authority and FTEs for biologics were rising in

the late 1980s and early 1990s, the graph shows that both decline and then remain flat coincident

with the introduction of user fees in 1993. Budget authority and FTEs increased between FY2001

and FY2003, coincident with increased emergency funding following the domestic terrorist

attacks. The drop in biologics funding and FTEs from FY2003 to FY2004 is due to the

reorganization of review responsibilities for therapeutic biologics. Following the reorganization,

budget authority and FTEs for biologics have remained relatively flat.

(...continued)

Federal Food, Drug, and Cosmetic Act rather than licensed under the Public Health Service Act.

FDA Press Release, “FDA to Consolidate Review Responsibilities for New Pharmaceutical Products,” September 6,

2002, at http://www.fda.gov/bbs/topics/NEWS/2002/NEW00834.html.

Federal Register, vol. 68, no. 123, June 26, 2003, pp. 38067-38068. Examples of products transferred to CDER

include monoclonal antibodies; proteins intended for therapeutic use (interferons, thrombolytic enzymes);

immunomodulators (other than vaccines and allergenic products); and growth factors, cytokines, and monoclonal

antibodies intended to alter production of blood cells. See Transfer of Therapeutic Products to the Center for Drug

Evaluation and Research http://www.fda.gov/cber/transfer/transfer.htm; Approved Products Transferring to CDER

http://www.fda.gov/cber/transfer/transfprods.htm; and Therapeutic Biological Products http://www.fda.gov/cder/

biologics/default.htm.

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Figure 7. Biologics: Budget and FTEs (Constant FY2000 $)

Sources: For FY1980-FY2006, FDA Justification of Estimates for Appropriations Committees documents. FY2007

FTE data are based on an interim continuing resolution used in the FY2008 Justification and therefore do not

reflect final action by Congress. FY2007 budget data reflect the Operating Plan developed after passage of P.L.

110-5, Revised Continuing Appropriations Resolution, 2007.

Notes: For FY1983 through FY1987, FDA managed Biologics activities and Human Drugs activities in one

Center. The Justifications for those years provide only combined dollar and FTE numbers, which are included in

Figure 6(Human Drugs) and not in Figure 7 (Biologics). Total FTEs = Budget Authority FTEs + User Fee FTEs.

Program Level $ = Budget Authority $ + User Fees $.

FDA’s responsibilities related to the approval and regulation of biological products have changed

somewhat between 1980 and 2007 (see

Table 4). In 1980, FDA’s authority with respect to the approval of biological products was

governed primarily by Section 351 of the Public Health Service Act (P.L. 78-410). In addition,

because most biological products also meet the definition of “drugs,” they are subject to

regulation under the FFDCA (P.L. 59-384). FDA also regulates medical devices involving

biologics under various medical device laws. Examples include devices used in blood banks to

produce various blood products, such as automated cell separators, empty plastic containers and

transfer sets, and blood storage refrigerators and freezers.

By 2007, the passage of additional laws had created more responsibilities and authorities for FDA

in the area of biologics. The Pediatric Research Equity Act of 2003 (P.L. 108-155) requires a

pediatric assessment of safety and effectiveness as part of an application to license a new

biologic, or, if the Secretary considers it necessary, for an already licensed biologic. The Project

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Bioshield Act of 2004 (P.L. 108-276) requires FDA to provide an expedited review of vaccines

and other countermeasures to bioterrorism agents.

Congress is also currently considering proposed legislation that would expand the agency’s

regulatory activities by opening a pathway for the approval of so-called follow-on biologics,

which are similar, but not identical, to the brand-name products made by the pharmaceutical or

biotechnology industry.92 The new regulatory pathway would be analogous to the FDA’s authority

for approving generic chemical drugs under the Drug Price Competition and Patent Term

Restoration Act of 1984 (P.L. 84-417), often referred to as the Hatch-Waxman Act. FDA

personnel have been actively involved for some time in working with Congress on this potential

new responsibility.

Table 4. Biologics Statutory Authorities in 1980 and 2007

Authorities in 1980

Licenses new biological products that are shown to be safe, pure, and potent and inspects manufacturing facilities to

assure the product continues to be safe, pure, and potent (P.L. 78-410).

Regulates medical devices involving blood products or other biologics (P.L. 75-717).

Regulates biological products (P.L. 87-781).

Regulates advertising of biological products (P.L. 87-781).

Authorities Added Between 1980 and 2007

Assesses and collects fees from biologics manufacturers and uses the resulting revenue to support the review of new

biologic products (P.L. 102-571, P.L. 105-115, P.L. 107-188).

Collect user fees for premarket device review (P.L. 107-250, P.L. 108-214, P.L. 109-43).

Requires a pediatric assessment of safety and effectiveness as part of an application to license a new biologic, or, if the

Secretary considers it necessary, for a licensed biologic (P.L. 108-155).

Expedites review of countermeasures to agents that may be used in a terrorist attack (P.L. 108-276).

Animal Drugs and Feeds93

The FDA Center for Veterinary Medicine (CVM) regulates animal feeds (such as livestock feeds

and pet foods), and veterinary drugs and devices. 94 CVM is responsible for premarket approval of

veterinary drugs, based on a sponsor’s demonstration of safety and effectiveness. CVM regulates

veterinary devices, but does not require their premarket approval.95 Veterinary biologics are

regulated by the USDA. 96 Much of CVM’s authority is based in FDA’s general authorities in the

FFDCA, such as the authority to take enforcement actions if a regulated product is adulterated, to

For further information, see CRS Report RL34045, FDA Regulation of Follow-On Biologics, by (name redacted).

This section was prepared by (name redacted), Specialist in Public Health and Epidemiology.

See http://www.fda.gov/cvm/.

FDA can take appropriate regulatory action if a veterinary device is misbranded, mislabeled or adulterated. Also,

firms that manufacture radiation-emitting veterinary devices must register their products under the radiological health

regulations, administered by the FDA Center for Devices and Radiological Health (CDRH). See FDA CVM, “How

FDA Regulates Veterinary Devices,” May 2003, at http://www.fda.gov/cvm/regofdevices.htm.

Veterinary biologics, such as vaccines and clinical laboratory tests, are regulated by the USDA, Animal and Plant

Health Inspection Service, Center for Veterinary Biologics. See http://www.aphis.usda.gov/animal_health/

vet_biologics/.

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require facility registration, and to conduct inspections. For example, animal feed is included in

the definition of “food” in Section 201 of the FFDCA, and must meet the same general standards

of safety as human food, pursuant to Sections 401 et seq. of the act. Additional specific

requirements may also be applied to CVM-regulated products.

Though USDA and FDA-CFSAN have primary responsibility for the safety of products intended

for human food, 97 CVM is responsible for some specific aspects of the safety of human foods

derived from animals, such as determining tolerances (safe levels) of certain chemicals in meat

and poultry, and evaluating the food safety aspects of animal clones and their offspring. Also,

before CVM approves an animal drug, its use in animals must be shown to be safe for humans as

well. Drug sponsors must demonstrate that a method is available to detect and measure any drug

residues left in edible tissues of food-producing animals. Farmers and veterinarians who use

drugs on food-producing animals must adhere to guidelines about how much time must elapse

before a treated animal can be slaughtered, or before its milk can be marketed, and any other

constraints or warnings that are stated on the drug label.

Figure 8 shows the total FDA budget for animal drugs and feeds, composed of budget authority

and user fees, for FY1980 through FY2007, adjusted to FY2000 dollars.98 Figure 8 also provides

FTE data over the same period: FTEs funded by budget authority; and total FTEs funded at

program level (budget authority plus user fees). During that time, the budget in adjusted dollars

increased from $46.7 million in FY1980 to $87.6 million in FY2007. FTEs totaled 516 in

FY1980, and 619 in FY2007, though there were fewer than 500 FTEs for most of the intervening

years. Drug user fees provided a small portion of CVM’s overall budget between FY2004 and

FY2007, and made up about 11% of the FY2007 total. (FDA did not have authority to collect user

fees for new animal drug reviews until FY2004.)

The budget for animal drugs and feeds, in adjusted dollars, almost doubled in the three-year

period from FY1999 to FY2002, from $44.3 million to $82.4 million. FTEs increased from 393 to

570 in the same period. (The budget was relatively stable in the years before and after this period

of growth, when adjusted for inflation.) The funding increases largely paralleled increasing

budget requests for those years. Increases were requested to support new statutory requirements

as well as several initiatives, some of which were agency-wide. These initiatives included

activities in food safety, antimicrobial resistance, and postmarket surveillance of drug safety, as

well as efforts to reduce drug review times. They also included a bioterrorism preparedness

initiative, and the expansion of feed safety programs to protect against Bovine Spongiform

Encephalopathy (BSE, or “Mad Cow disease”). In each case, funding was expanded prior to a

related high-profile incident, namely the 2001 anthrax attacks, and the 2003 emergence of BSE in

North America.

Prior to 1980, CVM was responsible for evaluating veterinary drugs for approval based on

demonstrations of safety and efficacy, and for assuring the safety of animal feeds and feed

additives. Several laws enacted since 1980 were aimed at improving the availability of veterinary

drugs (which are typically not as lucrative for sponsors as are human drugs), clarifying the use of

human drugs in animals, or streamlining the drug approval process. FDA’s authority for animal

See CRS Report RS22600, The Federal Food Safety System: A Primer, by (name redacted) and (name redacted).

Though CVM was called the Bureau of Veterinary Medicine prior to 1984, the Center and the Animal Drugs and

Feeds budget line have, for practical purposes, encompassed the same activities for several decades, and references to

each are used interchangeably.

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products generally begins with the same statutes as those that regulate human drugs and foods

(see Table 2 and Table 3), with additional specific requirements applied in some cases.99 This is

consistent with FDA’s long-standing obligation to assure that veterinary drugs and animal feeds

are manufactured and used in ways that are safe for both animals and humans.

Figure 8. Animal Drugs and Feeds: Budget and FTEs(Constant FY2000 $)

Sources: For FY1980-FY2006, FDA Justification of Estimates for Appropriations Committees documents. FY2007

FTE data are based on an interim continuing resolution used in the FY2008 Justification and therefore do not

reflect final action by Congress. FY2007 budget data reflect the Operating Plan developed after passage of P.L.

110-5, Revised Continuing Appropriations Resolution, 2007.

Notes: Total FTEs = Budget Authority FTEs + User Fee FTEs. Program Level $ = Budget Authority $ + User

Fees $.

Major laws affecting CVM’s regulation of animal drugs and feeds are summarized in Table 5.100

In 1988, the Generic Animal Drug and Patent Term Restoration Act (P.L. 100-670) authorized

abbreviated applications for generic new animal drugs. In 1994, the Animal Medicinal Drug Use

An exception to this general rule is the Dietary Supplement and Health Education Act (DSHEA) of 1994, which

requires that FDA not designate substances added to “food for humans” as food additives or drugs if the product meets

the definition of a dietary supplement. FDA has interpreted that DSHEA does not apply to products added to animal

feeds. Consequently, CVM regulates any animal feed supplement as either a food, food additive, or animal drug,

depending on the intended use, and does not apply the additional dietary supplement category.

100

The Center’s statutory authorities are discussed in greater detail on a public website, “Chronological History of

CVM,” at http://www.fda.gov/cvm/chronological.htm.

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Clarification Act (P.L. 103-396) permitted veterinarians to prescribe, for animals, extra-label uses

of certain approved animal and human drugs, under certain conditions. In 1996, the Animal Drug

Availability Act (P.L. 104-250) granted FDA more flexibility in evaluating and approving new

animal drugs by amending the definition of substantial evidence of effectiveness. Among other

provisions, the law also permitted the use of veterinary drugs in animal feeds, with veterinary

prescription.

In 2002, the Public Health Security and Bioterrorism Preparedness and Response Act (P.L. 107188) required the registration of all domestic and foreign facilities that manufactured, processed,

packed or held animal feeds. 101 In 2003, the Animal Drug User Fee Act (P.L. 108-130) authorized

FDA to collect fees for the review of certain animal drug applications.102 In 2004, the Minor Use

and Minor Species Animal Health Act (P.L. 108-282) authorized, along with other approaches and

incentives for limited-market drugs, the conditional approval for drugs to treat minor animal

species and uncommon diseases in major animal species,103 which allows the sponsor to make a

drug available before collecting all necessary effectiveness data, but after proving that the drug is

safe. In 2007, the FDAAA (P.L. 110-85) required, for pet foods, the development of ingredient,

processing and labeling standards, and a surveillance system to detect disease outbreaks.

Additional provisions that apply to both human foods and animal feeds require, among other

things, that FDA establish a reportable food registry, and that persons in charge of FDA-registered

food facilities report any instances of tainted foods that may harm humans or animals.

Table 5. Animal Drugs and Feeds Statutory Authorities in 1980 and 2007

Authorities in 1980

Prohibits interstate commerce in adulterated and misbranded feeds; provides criminal penalties for violations and authorizes seizures

of offending products (P.L. 59-384).

Review evidence of safety (P.L. 75-717) and effectiveness (P.L. 87-781) before approving an animal drug.

Review safety and effectiveness of animal drugs for intended use, including safety for use in food-producing animals (P.L. 90-399).

Authorities Added Between 1980 and 2007

Authority for abbreviated applications for generic animal drugs (P.L. 100-670).

Authority for veterinarians to prescribe, for animals, extra-label uses of certain approved animal and human drugs, under certain

conditions (P.L. 103-396).

Added flexibility in approving new animal drugs, including an amended definition of substantial evidence of effectiveness. Granted

authority for the use of veterinary drugs in animal feeds, with veterinary prescription (P.L. 104-250).

Requirements for facilities that manufacture, process, pack, or hold animal feed for domestic consumption to register and maintain

records (P.L. 107-188).

Authority to collect user fees for certain animal drug applications (P.L. 108-130).

Conditional approval of veterinary drugs for minor uses or minor species, based on demonstration of safety without all necessary

effectiveness data (P.L. 108-282).

Required, for pet foods, the development of ingredient, processing and labeling standards, and a surveillance system to detect

disease outbreaks. Required, for both human foods and animal feeds, the establishment of a reportable food registry, and mandatory

reporting of instances of tainted foods (P.L. 110-85).

101

The law applied similarly to human food facilities.

102

The law is similar to the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee and

Modernization Act (MDUFMA) for human products.

103

For more information on minor uses and minor species, see http://www.fda.gov/cvm/minortoc.htm.

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Devices and Radiological Health104

FDA is responsible for ensuring the safety and effectiveness of medical devices and eliminating

unnecessary human exposure to man-made radiation from medical, occupational, and consumer

products.105 There are thousands of types of medical devices, from heart pacemakers to contact

lenses. Radiation-emitting products regulated by the agency include microwave ovens, video

display terminals, and medical ultrasound and x-ray machines. FDA reviews requests to research

or market medical devices; collects, analyzes, and acts on information about injuries and other

experiences in the use of medical devices and radiation-emitting electronic products; sets and

enforces good manufacturing practice regulations and performance standards for radiationemitting electronic products and medical devices; monitors compliance and surveillance

programs for medical devices and radiation-emitting electronic products; and provides technical

and other nonfinancial assistance to small manufacturers of medical devices. The agency’s current

activities related to devices and radiological health (DRH) are primarily conducted by its Center

for Devices and Radiological Health. As previously noted, CBER regulates some devices—

specifically those associated with blood collection and processing procedures, as well as with

cellular therapies (e.g., stem cell treatments).

In FY1980, after adjusting for inflation, FDA’s DRH budget was $97,427,000, which supported

1,399 FTEs (see Figure 9). At that time, the agency’s responsibilities with respect to devices were

governed primarily by the Medical Device Amendments of 1976 (MDMA, P.L. 94-295). MDMA

was the first major legislation passed to ensure the safety and effectiveness of medical devices,

including diagnostic products, before they could be marketed. The amendments required

manufacturers to register with FDA and follow quality control procedures in their manufacturing

processes. They also required FDA to conduct premarket review of some products, and to

generate performance standards that devices had to meet before they could be marketed.

Between FY1980 and FY2007, several major pieces of device legislation were passed (see Table

6). Some of these added new types of responsibilities. In 1990, Congress gave FDA the authority

to enforce postmarket requirements for devices, to act on postmarket adverse event reports, and to

recall unsafe devices (P.L. 101-629). In 1992, Congress gave FDA the authority to require that

manufacturers of defective products implement certain consumer accommodations and pursue

penalties for postmarket surveillance noncompliance (P.L. 102-300). In 1997, Congress passed

the Food and Drug Administration Modernization Act (FDAMA), major FDA reform legislation

that tasked the agency with accelerating its premarket review and regulating unapproved uses of

approved devices (P.L. 105-115).

Other legislation contained provisions that could reduce or minimize, rather than simply increase,

the regulatory burden on FDA. For example, while the Mammography Quality Standards Act

(MQSA) added the responsibility of requiring the agency to certify mammography facilities, it

also provided the authority to collect associated certification fees, creating a new revenue stream

(P.L. 102-539). MQSA also allowed certain accredited third-parties to conduct inspections in

order to relieve FDA of some of that responsibility.

104

This section was prepared by (name redacted), Specialist in Public Health and Bioethics.

For further information, see CRS Report RL32826, The Medical Device Approval Process and Related Legislative

Issues, by (name redacted).

105

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In 2002, Congress passed the largest revenue-generating, non-appropriations legislation for

FDA’s DRH-related activities in the 28-year period under examination: the Medical Device User

Fee and Modernization Act (MDUFMA, P.L. 107-250).106 The law gave FDA the authority to

collect user fees for premarket device review, creating another significant source of revenue. It

also accredited third-parties to conduct inspections, a measure designed to reduce FDA’s

regulatory burden. To preclude user fees from supplanting direct appropriations, MDUFMA

contained a “trigger,” requiring a certain amount of DRH-related direct appropriations for the

collection of user fees to continue. In 2005, direct appropriations did not meet the trigger amount.

Congress subsequently reduced the trigger amount so FDA could continue to collect the user fees

(P.L. 109-43).

Between FY1980 and FY2007, congressional appropriations for DRH-related activities generally

followed the agency’s budget requests. As Figure 9 indicates, the number of FTEs and budget

remained relatively flat through the 1980s. Both then increased in the early 1990s. Beginning in

the late 1990s, the budget and FTEs began to track somewhat differently than they had in the

past.107 The flat budget in the late 1990s did not occur with a fairly constant number of FTEs as it

had in the 1980s, but rather with a decrease in FTEs. Likewise, the budget increases that have

occurred thus far in the 2000s have increased the number of FTEs, but not by as much as with

similar budget increases in the early 1990s. Readers should note that the drop in FTEs between

FY2006 and FY2007 apparent in Figure 9 is misleading, as the FTE numbers are based upon a

continuing resolution (which had no allowance for user fees), while the budget numbers are based

upon a cost estimate (which did include user fees).

106

For further information about medical device user fees, see CRS Report RL34571, Medical Device User Fees and

User Fee Acts, by (name redacted).

107

For a general discussion of the relationship between FTE data and budget data, see “Overall FDA Budget“ and

“FDA Activity-Area Budgets“ sections of this report.

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Figure 9. Devices and Radiological Health: Budget and FTEs (Constant FY2000 $)

Sources: For FY1980-FY2006, FDA Justification of Estimates for Appropriations Committees documents. FY2007

FTE data are based on an interim continuing resolution used in the FY2008 Justification and therefore do not

reflect final action by Congress. FY2007 budget data reflect the Operating Plan developed after passage of P.L.

110-5, Revised Continuing Appropriations Resolution, 2007.

Notes: Total FTEs = Budget Authority FTEs + User Fee FTEs. Program Level $ = Budget Authority $ + User

Fees $.

The net result of the changes described above was that, over the 28-year period studied, FDA’s

budget and its number of FTEs dedicated to DRH-related activities increased, although by

different amounts. Adjusted for inflation, the total DRH-related budget has increased by 124.5%.

The number of FTEs increased by 7.1%. Over the same 28-year period, adjusting for inflation,

the budget authority for DRH-related activities increased by 94.2%, while the number of FTEs

supported by the budget authority decreased by 5.1%. User fees, which comprised none of the

device-related budget in FY1980, comprised 13.5% of it in FY2006. User fee-funded FTEs,

which comprised none of the FY1980 budget, comprised 11.3% of the FY2006 budget.

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Table 6. Devices and Radiological Health Statutory Authorities in 1980 and 2007

Authorities in 1980

Regulates devices as drugs (Court interpretation of P.L. 75-717).

Enforces label truthfulness, accuracy (P.L. 89-755).

Ensures safety, effectiveness prior to marketing (P.L. 94-295).

Creates, enforces manufacturing quality control procedures (P.L. 94-295).

Maintains manufacturer registry (P.L. 94-295).

Authorities Added Between 1980 and 2007

Enforces postmarket requirements (P.L. 101-629).

Receives, acts on postmarket adverse event reports (P.L. 101-629).

Recalls unsafe devices (P.L. 101-629).

Orders certain consumer accommodations by defective product manufacturers (P.L. 102-300).

Pursues penalties for postmarket surveillance noncompliance (P.L. 102-300).

Certifies mammography facilities, collects associated fees (P.L. 102-539, P.L. 105-248, P.L. 108-365).

Accelerates premarket review (P.L. 105-115).

Regulates unapproved uses of approved devices (P.L. 105-115).

Collects user fees for premarket device review (P.L. 107-250, P.L. 108-214, P.L. 109-43).

Accredits third parties to conduct inspections (P.L. 107-250).

Enforces new regulatory requirements for reprocessed single-use devices (P.L. 107-250).

Other Activities and Responsibilities

The above analysis focuses on areas in which FDA has product-specific regulatory

responsibilities. However, certain components of FDA’s budget and responsibilities do not fall

within these categories (e.g., toxicological research, and headquarters and office of the FDA

Commissioner) or whose funding is included within each activity area budget (e.g., FDA’s field

activities). While an in-depth analysis of these areas is not included in this report, we have

provided a brief description of each one below.

Toxicological Research

FDA’s activities related to toxicological research are conducted by the National Center for

Toxicological Research (NCTR), in Jefferson, AR. NCTR, which was established by Executive

Order in 1971, does not have an explicit authority in law, and does not have direct regulatory

responsibilities. 108 NCTR conducts peer-reviewed scientific research and provides expert

technical advice and training to support FDA regulatory activities. NCTR uses Interagency

Agreements, CRADAs, informal collaborations, and visiting scientists to advance its research

activities.

108

See http://www.fda.gov/nctr/.

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Headquarters and Office of the Commissioner

The FDA Commissioner has broad authority and responsibility to conduct research to support the

agency’s mission. 109 The Office of the Commissioner (OC) is made up of several components,

including the Ethics Program, Good Clinical Practice Program, History Office, Office of

Combination Products, and Office of Crisis Management, among others.110

As reported in the FY1982 budget Justification, FY1980 funding for the OC was included in

FDA’s Program Management budget line. This line also included funding for the Associate

Commissioners and the general management personnel responsible for the central program

direction and administrative support functions of the agency. As reported in the FY2008 budget

Justification, funding for the OC in FY2006 was included under the title FDA Headquarters and

Office of the Commissioner. It consisted of agency-wide program direction, and administrative

services to ensure that FDA’s consumer protection efforts were managed and that available

resources were put to the most efficient use.

Field Activities: The Office of Regulatory Affairs

The lead office for FDA’s inspection and enforcement activities (which FDA calls “field

activities”) is the Office of Regulatory Affairs (ORA). ORA is comprised of its Headquarters, the

Office of Resource Management, the Office of Regional Operations, the Office of Enforcement,

and the Office of Criminal Investigations.111 In almost every Justification, field activity budget

and FTEs are included in each activity area.

Concluding Comments

This report provides information on changes in FDA’s resources, both budget and FTEs, as well

as the evolution of its statutory responsibilities. Resources and responsibilities are juxtaposed

because, as Congress requires more from the agency, it is important to assess whether FDA has

the necessary financial resources to meet all those statutory responsibilities. The report is

intended to assist Members and their staff in evaluating whether FDA’s resources have fallen

short, and, if so, how to enhance FDA’s performance.

The status of FDA resources and agency performance is important to Congress because each day

FDA-regulated products touch the lives of every American citizen as well as people around the

world. As stated previously, about 25% of American consumer dollars are spent on these FDAregulated products. Among the industries that FDA regulates are some of the most successful and

innovative in the U.S. economy. The agency regulates a wide range of products valued at more

than $1 trillion. Problems with their safety or effectiveness could affect anyone, as is evident from

the following sample of things FDA regulates:

•

the calorie and fat content information on food labels;

•

permissible and required information in televised prescription drug ads;

109

21 U.S.C. § 393(d)(2)(C).

See http://www.fda.gov/oc/.

111

See http://www.fda.gov/ora/about/default.htm.

110

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•

the coloring in foods, medicines, and cosmetics;

•

the purity of ingredients in prepared foods—for people and animals;

•

inspection requirements for mammography and MRI equipment; and

•

antibiotics in the feed fed to animals bred for human consumption.

The data in this report, assembled from the annual material that each President submits to

Congress for the next year’s appropriation, indicate some year-by-year variation, but mostly

illustrate a few trends. For FDA as a whole, comparing FY2006, the most recent year for which

we have parallel data sources for both dollars and FTEs, to FY1980 yields these inflationadjusted findings (see Figure 1):

FDA Budget:

•

almost a doubling of direct congressional appropriations (budget authority);

•

more than an 10-fold increase in other funds, mostly user fees;

•

resulting in an overall budget in FY2006 almost 2-1/2 times that in FY1980.

FDA FTEs:

•

less than a 1% increase in budget authority-funded FTEs;

•

an almost fourfold increase in FTEs funded by other sources, mostly user fees;

•

resulting in an overall 19% increase from FY1980 to FY2006.

Similar relationships are observed in each of the major activity areas that receive user fees (the

Foods program does not have user-fee funds) and are discussed in this report. The human drugs

program, along with biologics, was the first to include user fee revenue in its budget and is a good

example to illustrate the relationship over time between congressionally appropriated dollars and

user fee generated dollars. Again from FY1980 to FY2006, the data show that the human drugs

total budget (program level), which included user fee revenue, more than tripled (a 231%

increase) although the direct congressional appropriations (budget authority) increased by 78%.

The effect of user fees is even more evident in comparing the number of FTEs. The budget

authority funded FTEs decreased by 14%, but the overall human drug FTE level increased by

40% because of user fee funding. For the human drug program in FY2006, user fees contributed

46% of the budget and funded 39% of the FTEs.

In general, Congress has either kept direct appropriations in line with inflation (FY1980-FY1988,

FY1994-FY1997, and FY2002-2007) or increased them gradually (FY1989-FY1993 and

FY1998-FY2001). The exception is FY2002, when Congress increased direct appropriations to

FDA by 23%, along with increases to other public safety agencies in response to the attacks of

September 11, 2001, and the anthrax mailings soon after.

Congress and various administrations have allowed FDA’s research program to diminish and its

many data systems are not meeting the agency’s needs. The context of this report does not allow a

distinction between program decisions made by budget constraints and those made by policy

intent.

The focus of this report is the FDA budget. The discussion does not, therefore, explore other

possible constraints on FDA’s meeting its responsibilities and the public’s expectations. Such

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factors could include the agency’s lack of strong advocates, both externally (such as NIH has with

its patient advocacy groups) and internally (because of chronic vacancies in key leadership

positions, including the Commissioner). Independent of whether the FDA budget is sufficient to

cover agency responsibilities is how FDA manages the resources it does have. The influence of

non-budgetary factors likely complicates agency actions, though analyzing that is beyond the

scope of this report.

From 1980 through 2007, 36 new major statutes were enacted that address FDA activities. 112 This

report does not evaluate the impact of individual statutory requirements on the workload and

resources needs of the agency. However, an examination of the FDA Amendments Act of 2007

(FDAAA, P.L. 110-85) provides examples of the funding issues discussed in this report. Some

news coverage of FDAAA hailed it as “the most sweeping overhaul of the Food and Drug

Administration in a decade.”113 In addition to the widely expected reauthorization of drug and

device user fees and pediatric drug research incentives, FDAAA, among other things, authorized

demonstration grants, including ones for improving pediatric device availability; established

mechanisms for public-private partnerships to support FDA’s mission to accelerate medical

product innovation, translational therapeutics, and enhanced medical product safety; required an

expanded clinical trial registry databank; and strengthened FDA’s authority to require studies and

labeling changes for drugs already on the market.

Implementation of these and other provisions is to involve the development of new regulations

and extensive communication with industry and the public. Carrying out these new

responsibilities will require time and resources. To fund all these provisions, FDAAA authorized

annually an additional $250 million in appropriations and $32 million in user fee revenue. 114

Absent appropriations, these authorizations remain congressional statements of intent.

This report has focused on the presentation of FDA’s financial and human resources and statutory

responsibilities over time. In presenting that information in context, the report also identifies

actions—other than a straightforward increase in direct appropriations—that others have

suggested as possible steps to help FDA’s budget situation. These propose to:

•

Restructure the PDUFA trigger mechanism to minimize its unintended effect of

pulling resources from non-PDUFA activities.

•

Authorize FDA to bypass the HHS and OMB budget offices in submitting its

request for appropriations to Congress.

•

Require, in addition to the OMB-processed budget request, that the FDA

Commissioner submit to Congress a Professional Judgment budget based on his

or her personal expertise and experience.

112

This number is held down by the concatenation of many introduced bills into large packages passed as single items.

For example, FDAAA of 2007 is counted once although it included the Prescription Drug User Fee Amendments of

2007, the Medical Device User Fees Amendments of 2007, the Pediatric Medical Device Safety and Improvement Act

of 2007, the Pediatric Research Equity Act of 2007, and the Best Pharmaceuticals for Children Act of 2007, among

many other items.

113

Drew Armstrong, “Major Elements of the FDA Overhaul,” CQ Weekly: Health, September 24, 2007, p. 2767.

114

FDAAA included other provisions that could (but do not necessarily) affect FDA’s total program level. These are

direction to transfer appropriated funds for specified purposes, authority to assess certain civil penalties, and authority

to appropriate funds for certain grants and contracts.

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•

Move FDA appropriations from the appropriations subcommittees on agriculture

to the Labor-HHS subcommittees, which handle most other agencies involved in

protecting the public’s health.

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Appendix. Methodology

This report tracks, as consistently as possible with publicly available material, the FDA budget

numbers and employee numbers (FTEs) from FY2007 back to FY1980. The goal was to provide

about 25 years of budget and FTE history accompanied by changes in the agency’s statutory

responsibilities. Only limited budget and FTE data are available from bills and reports of the

congressional appropriations committees. Citing constraints on its staff time, FDA indicated that

it would only be able to provide data for recent years. Therefore, this report used data prepared

annually by FDA for Congress at the beginning of each budget cycle and presented in the

Justification documents. The Justifications are prepared initially by FDA and transmitted through

HHS to OMB, often with adjustments made by HHS and OMB. These documents provide

detailed budget and FTE data along with an extensive narrative.

Over the years, changes in agency organization, accounting methods, definitions, and other

conditions resulted in variations in data presentation in the Justification documents. Although

some data inconsistencies found in the documents could be explained, other inconsistencies could

not. This section of the report provides the basic approach used to calculate historical budget and

FTE numbers, highlights inconsistencies among the Justification documents, and describes the

steps taken to make the data as consistent as possible. There may be additional data

inconsistencies that were not found because they were less readily apparent.

The annual Justification documents present first the overall FDA information (narrative, and

budget and FTE data) followed by information for the various activity areas within the agency.

Except as noted below, this report uses data from the Actuals column in tables labeled: All

Purpose Table—Total Program Level; All Purpose Table—Budget Authority; and All Purpose

Table—User Fees. These tables are found at the beginning of each Justification document. The

report also uses activity-specific data from similar tables that are included at the beginning of the

Justification’s narrative section on each activity area.

Overall FDA Budget

The FDA’s total budget, also called the program level, consists of (1) direct congressional

appropriations, referred to by FDA as budget authority, and (2) funds collected or transferred

from other sources, which this report refers to as other funds and which FDA lists under user fees

in recent Justifications. Other funds include all of the financial and FTE resources that are

available to FDA as itemized in the Justifications that are from sources other than direct

congressional appropriations. In recent years, the largest component of other funds comes from

user fees collected under the authority of the Prescription Drug User Fee Act, the Medical Device

User Fee and Modernization Act, and the Animal Drug User Fee Act. Grouped separately in some

years’ Justifications are other fees obtained under the Mammography Quality Standards Act, and

fees collected for color certification, export certification, and Freedom of Information Act (FOIA)

requests. Additional sources itemized in the Justifications include advances and reimbursements;

Parklawn Computer Center FTEs; CRADAs; and P.L. 83-480 (Agricultural Trade Development

and Assistance Act of 1954) funds. Note that overall FDA budget authority includes

appropriations for both “Salaries and Expenses” and “Buildings and Facilities.” (In contrast, as

indicated below, activity-area budgets include only “Salary and Expenses.”)

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Activity Area Budgets

This report follows the order in the FY2008 Justification document in presenting information on

FDA’s five major activity areas: Foods, Human Drugs, Biologics, Animal Drugs and Feeds, and

Medical Devices and Radiological Health. For each activity area, the Justification provides the

amount given by direct congressional appropriations (budget authority) and user fees (a narrower

category than other funds), the total of which is the program level.

The Justification documents do not allocate an amount for Buildings and Facilities to each

activity-area. Buildings and Facilities is recorded as a separate line within the overall FDA

budget. Activity area amounts in this report’s tables and graphs are for Salaries and Expenses.

The report groups remaining FDA activities (Toxicological Research), agency-wide

responsibilities (Headquarters and Office of the Commissioner) and expenditures (Rent,

Buildings and Facilities) into an “Other Activities” category. Tables A2 and A3 in the Appendix

of this report include budget and FTEs for Other Activities within the FDA Total columns, but do

not provide a separate Other Activities column. Budget amounts for Other Activities are included

in Figure 1 and Figure 3, which present overall FDA data.

Inflation Adjustment

Data in Table A-2 in the Appendix are as reported in the Justifications and have not been

adjusted for inflation. For Figures 1 and 2 as well as Figures 4-9, data have been adjusted for

inflation using “Total Non-Defense” deflators from Table 10.1, Gross Domestic Product and

Deflators Used in the Historical Tables: 1940-2012, found on pages 192-193 in: Office of

Management and Budget, Historical Tables, Budget of the United States, Fiscal Year 2008.

Basic Approach

As stated above, this report uses data found in the Actuals column of tables in the Justification

documents.115 Budget and FTE information for each activity area found in the overall summary

tables at the front of the Justification document was compared with information found in the

tables within the activity-area sections of the same document for confirmation. When a

Justification included inconsistent information, Justification documents from the preceding and

succeeding fiscal years were used to resolve the problem. The steps taken to resolve specific

inconsistencies are described below in Table A-1 in the Appendix. The reporting format that

FDA has used within the Justification documents to describe both its overall budget and those of

its various activities has changed over the past 28 years. The format in this report was kept as

consistent as possible with the format found in the FY2008 Justification.

115

Actuals data for a specific fiscal year can be found in the Justification document proposing the agency’s budget two

fiscal years later. For example, the Actuals data for FY2001 come from the FY2003 Justification.

Congressional Research Service

Table A-1. Actions Taken to Address FDA Budget Data Limitations

Fiscal

Year

Limitation in Source Material

Authors’ Decision for Report Presentation

19801982

FTE and budget amounts for Medical Devices and for Radiological Health were reported

separately.

Medical Devices and Radiological Health numbers were added together to

create a category consistent with the current Justification.

19801985

FTE and budget amounts for Foods were separated into three categories: food safety,

food labeling or food economics, and cosmetics.

The three categories were added together to create a category consistent

with Foods in the current Justification.

19801985

For FY1980-FY1985, the Justifications did not have a summary Budget Authority table

that included both Salaries & Expenses and Buildings & Facilities.

Salaries & Expenses and Buildings & Facilities were added together to

obtain the budget authority total for the agency.

19801985

In contrast to the FY2008 All Purpose tables, the Appropriation Summary tables in the

FY1981-FY1986 Justifications contained only direct appropriations (budget authority)

amounts and did not provide amounts for other funds or program level. The “Total

Resources Available” table reported other funds available to FDA. These other funds

amounts are reported only for the request year and the preceding year. The table labels

did not indicate whether the amounts are estimates or actuals.

For FY1980-FY1985, data from the “Total Resources Table” in the

FY1981-FY1986 Justifications were used to construct an other funds

amount.

19831987

Human Drugs and Biologics activities merged in 1983 to form the Center for Drugs and

Biologics which split in 1987 to form CDER and CBER. Justifications reports combined

Human Drugs and Biologics FTE and budget amounts for these years.

Tables and figures in this report include footnotes explaining the absence

of Biologics data and the jump in Human Drugs resources for these years.

19861988

In contrast to the FY2008 All Purpose tables, the Appropriation Summary tables in the

FY1988-FY1990 Justifications contained only direct appropriations (budget authority)

amounts and did not provide amounts for other funds or program level. The “Total

Resources Available” table reported other funds available to FDA. These amounts are

reported as estimates for the request year and the preceding year and as actuals for the

year two years prior to the request.

Amounts labeled Actual in the “Total Resources Available” table were

used to calculate other funds.

The amount labeled “Total” in the “Total Resources Available” table is equal to program

level and the amount labeled “Program Expenses” is equal budget authority. The

“Program Expenses” amount is the same as the amount labeled “Total Appropriation”

or “Total Obligational Authority” in the FDA Appropriation Summary table.

Other funds and budget authority amounts were added to obtain program

level totals.

19891991

In contrast to the FY2008 All Purpose tables, the Appropriation Summary tables in the

FY1991-FY1993 Justifications contained only direct appropriations (budget authority)

amounts and did not provide amounts for other funds or program level. The “Total

Resources Available” table reported other funds available to FDA. These amounts are

reported as estimates for the request year and the preceding year and as an actual

amount for the year two years prior to the request.

In contrast to above, the amounts labeled Actual in the “Total Resources

Available” table were not used to calculate other funds.

19891991

In the “Total Resources Available” table, the amount labeled “Total” is equal to program

level; however, the amount labeled “Program Expenses” is not equal to budget authority.

The “Program Expenses” amount is not the same as the amount labeled “Total

Other funds were calculated by subtracting the amount labeled “Total

Obligational Authority” in the FDA Appropriation Summary table from

CRS-44

Other funds and budget authority amounts were added to obtain program

level totals.

Fiscal

Year

Limitation in Source Material

Authors’ Decision for Report Presentation

Obligational Authority” in the FDA Appropriation Summary table.

the amount labeled “Total” in the “Total Resources Available” table.

19921993

The “FDA Budget Authority by Activity” table in the FY1994 and FY1995 Justifications

contained information similar to that presented in the “All Purpose Tables” of FY2000FY2008. However, the tables in the FY1994 and FY1995 Justifications categorize the

information differently: excluding several items from the recent years’ “User Fee”

category; and omitting a summary equivalent to either “All Purpose—Budget Authority”

or “All Purpose—Program Level” as provided in the FY2000-FY2008 Justifications.

Individual items from the FY1994 and FY1995 “FDA Budget Authority by

Activity” tables were placed in “program level,” “budget authority,” and

“other funds” categories in a manner consistent with their presentation in

the “All Purpose Tables” in the FY2000-FY2008 Justifications.

19941997

The FY1996-FY1999 Justifications contained tables at the beginning of the document that,

although not labeled as such, have formats and information similar to the “All Purpose

Tables” in the FY2000-FY2008 Justifications. The tables are titled “FDA Budget Authority

by Activity” in the FY1996 and FY1997 Justifications and “FDA Congressional Budget

Request” in the FY1998 and FY1999 Justifications.

The “FDA Budget Authority by Activity” tables and the “FDA

Congressional Budget Request” tables were used as the data source.

1993

The overall FDA amount for other funds includes $8,949,000 in Prescription Drug User

Fee Act (PDUFA) fees, but a comparable entry is not included in the budget of Human

Drugs or Biologics (as is the case for FY1994 through FY2008).

The PDUFA user fee amount was included in the other funds category of

the overall FDA budget. In the absence of activity-level data for the

PDUFA fees, the PDUFA user fee amount was not included in the user

fees category of Human Drugs, Biologics, or any other activity area

budget.

2003

The FY2005 Justification reported two different overall FDA budget authority amounts in

the All Purpose Tables. The overall FDA budget authority is $1,390,071,000 in the All

Purpose Table—Budget Authority, and $1,398,350,000 in the All Purpose Table—Total

Program Level, a difference of $8,279,000.

Other sections in the FY2005 Justification indicated that the table labeled

All Purpose Table—Total Program Level likely contained incorrect

amounts for the Offices of External Relations and International &

Constituent Relations. The overall FDA budget authority amount of

$1,390,071,000 from the All Purpose Table—Budget Authority was used.

2004

The FY2006 Justification organized data—including Actual data for FY2004—in a format

different than other Justifications. That year, activity totals did not include amounts for

Office of Regulatory Affairs, but did include rent. In the FY2007 and FY2008 Justifications,

FDA reverted to the previous format for all activities except for Human Drugs and

Biologics.

For Human Drugs and Biologics, FY2004 numbers were reconstructed by

adding in Office of Regulatory Affairs amounts and subtracting rent to

make them consistent with other years. For the remaining activities

(Foods, Animal Drugs and Feeds, and Medical Devices and Radiological

Health), amounts from the FY2008 Justification were used.

2007

FY2007 ended without passage of an Agriculture appropriations bill. The FY2008

Justification used FY2007 amounts from a continuing resolution in effect at the time.

Later, a Revised Continuing Appropriations Resolution was enacted. An FDA Operating

Plan for FY2007 (dated March 2007) reflected the final funding levels under P.L. 110-5,

the Revised Continuing Appropriations Resolution, 2007 but did not contain FTE

numbers.

The FDA Operating Plan was used as the source of budget data. The

FY2008 Justification was used as the source of FTE data.

2008

Amounts for FY2008 in the FDA FY2008 Justification are the President’s Budget Request,

and, therefore, do not reflect any final action by Congress.

Amounts for FY2008 are labeled “Request” in the Appendix tables and

are not included in any graphs.

CRS-45

The Food and Drug Administration: Budget and Statutory History, FY1980-FY2007

Table A-2. FDA Appropriations, Overall and by Major Program, Budget Authority and Other Funding, FY1980 through FY2008,

Unadjusted for Inflation

(dollars in thousands)

FDA

Fiscal

Year

Foods

Human Drugs

Program

Levela

Budget

Authority

Other

Funds

Budget

Authority

Budget

Authority

1980

339,864

324,829

15,035

95,107

72,119

1981

346,294

331,420

14,874

92,373

1982

353,861

341,624

12,237

1983

397,896

391,387

1984

400,502

1985

Animal Drugs &

Feeds

Biologics

Budget

Authority

User

Fees

Budget

Authority

User

Fees

Budget

Authority

User

Fees

22,147

23,498

49,035

76,476

21,638

21,000

58,218

104,253

72,284

23,174

21,499

53,364

6,509

103,294

108,472

—b

22,011

58,836

392,649

7,853

116,000

114,335

—b

23,913

62,568

423,935

414,345

9,590

110,541

130,996

—b

23,427

67,263

1986

412,361

404,361

8,000

109,753

129,609

—b

22,778

65,561

1987

457,351

447,144

10,207

120,449

151,642

—b

24,866

70,972

1988

486,051

477,504

8,547

126,401

117,132

51,379

25,406

74,911

1989

552,447

542,343

10,104

141,211

131,215

60,471

24,452

78,457

1990

611,551

600,979

10,572

161,082

146,519

73,241

30,670

89,365

1991

707,467

688,392

19,075

183,899

176,402

83,086

35,256

104,778

1992

777,850

761,830

16,020

206,304

198,538

90,531

39,000

116,731

1993

824,105

796,869

27,236

204,690

211,647

98,281

38,017

129,025

1994

920,745

875,968

44,777

213,014

214,855

23,108

110,748

16,843

40,318

159,359

1995

948,268

869,230

79,038

216,398

217,940

48,413

104,113

25,651

41,684

157,021

1996

988,341

889,527

98,814

200,941

202,024

50,863

87,315

29,991

36,814

143,717

8,557

1997

997,005

880,743

116,262

191,183

201,079

53,336

96,256

26,384

36,216

147,372

12,449

1998

1,050,299

931,883

118,416

206,249

199,579

63,069

95,479

27,533

41,354

144,329

11,376

1999

1,129,993

985,279

144,714

235,168

200,423

77,876

95,023

29,342

43,253

145,790

13,218

2000

1,213,983

1,048,149

165,834

279,704

215,538

95,696

106,133

34,584

49,593

157,656

12,601

CRS-46

User

Fees

Devices & Radiol.

The Food and Drug Administration: Budget and Statutory History, FY1980-FY2007

FDA

Foods

Human Drugs

Animal Drugs &

Feeds

Biologics

Devices & Radiol.

Fiscal

Year

Program

Levela

Budget

Authority

Other

Funds

Budget

Authority

Budget

Authority

User

Fees

Budget

Authority

User

Fees

Budget

Authority

User

Fees

Budget

Authority

User

Fees

2001

1,278,147

1,099,311

178,836

287,504

218,515

103,965

108,303

38,927

64,070

165,306

12,259

2002

1,536,959

1,354,366

182,593

393,256

254,700

109,644

138,605

39,237

85,643

179,962

13,695

2003

1,627,656

1,390,071

237,585

406,824

274,073

129,775

145,318

48,118

87,659

193,350

23,935

2004

1,678,904

1,401,214

277,690

407,052

292,118

167,474

122,354

44,662

83,458

983

191,143

30,363

2005

1,777,474

1,452,274

325,200

435,517

291,484

190,650

123,109

47,575

90,484

7,538

214,962

29,320

2006

1,862,694

1,493,580

369,114

438,721

297,715

211,190

138,518

59,191

89,580

8,264

220,563

34,478

2007

2,007,727

1,574,194

433,533

457,105

315,138

255,238

144,547

65,738

94,749

9,537

230,710

42,237

2008c

2,084,649

1,640,659

443,990

466,726

324,438

232,358

155,073

60,762

94,809

11,523

240,122

45,254

Sources: FDA Justification of Estimates for Appropriations Committees documents.

Notes: FDA’s foods program budget does not include user fee revenue. Devices and Radiological Products were added for 1980, 1981, and 1982. User Fees in 1992 are

Revolving Fund—Certification Fees. User Fees in 1993 are PDUFA plus Revolving Fund—Certification Fees. Unclear how 1993 PDUFA user fees were allocated.

The FY2007 is Operating Plan for 2007 (Dated March 2007) reflecting funding levels under P.L. 110-5.

Total program level = budget authority (direct appropriations) + other funding (e.g., user fees).

For FY1983 through FY1987, FDA managed Biologics activities and Human Drugs activities in one Center. The Justifications for those years provide only combined

dollar amounts which are included in Human Drugs and not in Biologics.

FY2008 amounts are the Administration request levels.

CRS-47

The Food and Drug Administration: Budget and Statutory History, FY1980-FY2007

Table A-3. Full-time Equivalents, Overall and by Major Program, Budget Authority-Funded and Other-Funded, FY1980 through

FY2008

FDA FTEs

Other

Funds

Food

FTEs

Human Drugs FTEs

Total

Year

1980

7,816

366

8,182

2,408

2,102

1981

7,558

374

7,932

2,319

1982

7,011

374

7,385

1983

7,122

184

1984

7,089

1985

7,024

1986

6,832

User

Fee

Total

2,102

507

2,023

2,496

1,703

7,306

2,257

2,356

188

7,277

2,396

188

7,212

2,164

169

Total

7,001

2,091

Animal Drugs & Feeds

FTEs

Biologics FTEs

User

Fee

User

Fee

Total

507

516

490

499

1,703

410

446

2,356

—a

2,228

—a

2,446

—a

2,406

Total

Devices & Radiological

Health FTEs

User Fee

Total

1,399

499

1,375

446

1,161

450

1,258

—a

458

1,211

—a

426

1,259

2,406

—a

441

1,217

—a

441

1,238

1987

6,794

169

6,963

2,071

2,423

—a

1988

7,039

171

7,210

2,146

1,942

584

441

1,282

1989

7,228

170

7,398

2,377

1,913

674

414

1,263

1990

7,629

185

7,814

2,475

2,026

775

438

1,332

1991

8,267

183

8,450

2,637

2,263

824

483

1,482

1992

8,792

302

9,094

2,793

2,390

898

506

1,604

1993

8,939

200

9,139

2,695

2,449

969

485

1,683

1994

8,963

389

9,352

2,675

2,412

2,490

977

126

1,103

495

1,799

1995

8,811

453

9,264

2,590

2,278

295

2,573

954

158

1,112

468

1,831

1996

8,487

685

9,172

2,348

2,108

351

2,459

804

206

1,010

403

1,603

1,646

1997

8,354

817

9,171

2,226

2,069

446

2,515

861

209

1,070

382

1,619

1,667

1998

8,083

821

8,904

2,239

1,959

470

2,429

841

186

1,027

391

1,507

1,555

1999

7,851

1,059

8,910

2,339

1,846

610

2,456

791

198

989

393

1,432

1,480

2000

7,728

1,102

8,830

2,386

1,838

671

2,509

780

211

991

406

1,426

1,472

2001

7,805

1,184

8,989

2,445

1,824

711

2,535

786

255

1,041

442

1,428

1,473

CRS-48

The Food and Drug Administration: Budget and Statutory History, FY1980-FY2007

FDA FTEs

Other

Funds

Food

FTEs

Human Drugs FTEs

Animal Drugs & Feeds

FTEs

Total

User

Fee

Total

User

Fee

Total

Biologics FTEs

User

Fee

Year

2002

8,311

1,157

9,468

2,734

1,817

700

2,517

894

242

1,136

570

2003

8,940

1,317

10,257

3,167

1,920

776

2,696

947

282

1,229

596

2004

8,567

1,574

10,141

3,082

1,977

972

2,949

792

246

1,038

592

2005

8,181

1,729

9,910

2,943

1,837

1,081

2,918

768

273

1,041

2006

7,893

1,805

9,698

2,774

1,801

1,146

2,947

730

249

2007

7,510

1,529

9,039

2,613

1,703

1,122

2,825

776

2008b

7,987

1,902

9,889

2,702

1,826

1,205

3,031

838

Total

Devices & Radiological

Health FTEs

User Fee

Total

1,407

1,454

596

1,432

1,485

595

1,376

139

1,515

571

610

1,367

149

1,516

979

538

592

1,328

170

1,498

215

991

502

1,235

1,269

263

1,101

561

619

1,359

180

1,539

Source: FDA Justification of Estimates for Appropriations Committees documents.

Note: FDA’s foods program budget does not include user fee revenue.

For FY1983 through FY1987, FDA managed Biologics activities and Human Drugs activities in one Center. The Justifications for those years provide only combined

FTEs which are included in Human Drugs and not in Biologics.

FY2008 based on Administration request.

CRS-49

The Food and Drug Administration: Budget and Statutory History, FY1980-FY2007

Table A-4. Selected Public Laws Since 1848 Significantly Affecting FDA Activities

Public

Law

Title and Brief Description of Law

Activitya

Drug Importation Act (An Act to Prevent the Importation of Adulterated and Spurious Drugs and Medicines, 30th Congress,

Session 1, Chpt. 70; 1848; 237-239) required the Department of the Treasury (U.S. Customs Service) to inspect drugs from abroad for

quality, purity, and fitness for medical purposes.

Drugs

59-384

Pure Food and Drug Act of 1906, administered by the then-USDA Bureau of Chemistry, required the food division to prohibit inters

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