# Animal Drug User Fee Programs

> Briefs, arguments, decisions, and more.

URL: https://www.frixlaw.com/law-library/documents/crs%3ARL34459

## Record

- **Collection:** Congressional research report
- **Document type:** CRS Report
- **Published:** August 4, 2008
- **Citation:** RL34459

## Text

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Prepared for Members and Committees of Congress

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The Animal Drug User Fee Act of 2003 (ADUFA I, P.L. 108-130) gave the Food and Drug
Administration (FDA) initial authority to collect user fees from sponsors for the review of animal
drug applications. ADUFA mirrors fee programs for human drugs and medical devices. Program
authority sunsets October 1, 2008, and FDA would have to lay off staff in its review program if
the program were not reauthorized by then. ADUFA supporters—including companies that make
brand-name animal drugs, and livestock producer groups—considered ADUFA reauthorization to
be “must pass” legislation in the 110th Congress. A coalition of consumer groups opposed the
program and its reauthorization, citing, in particular, concerns about the safety of animal drugs
used in livestock production.
After negotiations with brand-name animal drug companies, FDA made several proposals for the
reauthorization of ADUFA (ADUFA II), including a near-doubling of the total amount of fees to
be collected in the future. The proposed increase would support continued enhancements of
FDA’s review program, further improvements in the timeliness of reviews, and the elimination of
a backlog of pre-approval inspections of foreign manufacturing facilities. FDA presented draft
reauthorizing legislation to Congress in April 2008. H.R. 6432, the Animal Drug User Fee
Amendments of 2008, a bill to reauthorize the program, was introduced on July 8, 2008.
Subsequently, the bill was forwarded without amendment to the full committee by the House
Energy and Commerce Subcommittee on Health, and was marked up by the full committee on
July 16, 2008.
ADUFA does not cover generic animal drugs. FDA has not been able to maintain the statutory
requirement for timeliness of generic animal drug reviews since ADUFA was enacted. FDA
presented a draft Animal Generic Drug User Fee Act (AGDUFA) to Congress in April 2008,
separate from the ADUFA II draft bill. H.R. 6433, the Animal Generic Drug User Fee Act of
2008, was introduced on July 8, 2008. Subsequently, the bill was forwarded without amendment
to the full committee by the House Energy and Commerce Subcommittee on Health, and was
marked up by the full committee on July 16, 2008.
On July 30, 2008, the House passed H.R. 6432, as amended, under suspension. The engrossed
(House-passed) bill incorporated an amended version of H.R. 6432 (ADUFA reauthorization), as
reported, and H.R. 6433 (AGDUFA), as reported, without amendment. On August 1, 2008, the
Senate took up the House-passed measure and passed it by unanimous consent. The measure has
been sent to the President, who is expected to sign it.
This report discusses aspects of ADUFA I, including funding and program performance; FDA’s
ADUFA II and AGDUFA proposals; congressional activity; and relevant issues. Appendix A
provides a summary of ADUFA I. Appendix B describes the FDA process for approval of animal
drugs. This report will be updated to incorporate legislative actions and other events as they
unfold.

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Background ..................................................................................................................................... 1
Overview of ADUFA I..................................................................................................................... 2
Legislative History .................................................................................................................... 2
Covered Products ...................................................................................................................... 3
Covered Activities..................................................................................................................... 3
Fee “Triggers”: Authority to Collect Fees................................................................................. 3
Types of Fees............................................................................................................................. 4
Fee Waivers ............................................................................................................................... 4
Program Performance................................................................................................................ 5
Brand-Name Animal Drugs ................................................................................................ 5
Generic Animal Drugs ........................................................................................................ 6
Program Funding and Financial Reports................................................................................... 8
Sunset Provision...................................................................................................................... 10
FDA Proposal for ADUFA Reauthorization .................................................................................. 10
Timeline .................................................................................................................................. 10
Content .................................................................................................................................... 10
Program Financing.............................................................................................................11
Enhancements to Performance Goals ...............................................................................11
FDA Proposal for Generic Animal Drug User Fees ...................................................................... 12
Congressional Action .................................................................................................................... 13
Hearings .................................................................................................................................. 13
Legislation............................................................................................................................... 13
Overview........................................................................................................................... 13
House Action..................................................................................................................... 14
Senate Action .................................................................................................................... 15
Issues for Congress........................................................................................................................ 15
ADUFA Program Performance ............................................................................................... 16
ADUFA Program Costs........................................................................................................... 16
Animal Drug Safety and Postmarket Review ......................................................................... 16
Antimicrobial Resistance ........................................................................................................ 17

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Table 1. ADUFA I Performance Goals ............................................................................................ 5
Table 2. Animal Drug Program Activities ....................................................................................... 7
Table 3. ADUFA I Funding History, FY2003-FY2008 ................................................................... 9
Table 4. FDA Proposed ADUFA II Funding Levels, FY2009-FY2013.........................................11
Table 5. FDA Proposed AGDUFA Funding Levels, FY2009-FY2013 ........................................ 12
Table A-1. Summary of Provisions in ADUFA I ........................................................................... 19
Table B-1. Terms Used in the Animal Drug Approval Process ..................................................... 22

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Appendix A. Summary of Provisions in ADUFA I ....................................................................... 19
Appendix B. The Animal Drug Approval Process......................................................................... 21

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Author Contact Information .......................................................................................................... 24

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The Animal Drug User Fee Act of 2003 (ADUFA I, P.L. 108-130) was signed by the President in
November 2003. It established a new requirement, effective in FY2004, for FDA to collect fees
from sponsors of brand-name animal drugs in order to reduce the backlog of reviews for those
products, decrease the time required for future reviews, and improve the predictability of the
review process. Representatives of animal drug research and development companies say that an
animal drug can take 7 to 10 years to develop, at a cost of $100 million or more.1 Predictable and
timely review is important to these companies. Companies that make generic animal drugs, which
are not currently covered by a user fee program, want review of their products to be timely and
predictable as well.2 Moreover, veterinarians, animal producers, pet owners, and consumers have
an interest in the safety, availability, and affordability of animal drugs, including their safety when
used in livestock production.
Animal drug user fee authority sunsets October 1, 2008.3 If the program were not reauthorized by
then, FDA would have been prohibited at that time from collecting user fees, and would have to
lay off animal drug review staff. FDA began discussions with animal drug sponsors regarding
ADUFA reauthorization (ADUFA II) in the spring of 2007. In 2008, FDA published its
reauthorization proposal in the Federal Register in February, held a public meeting in March, and
accepted public comments through mid-April. On April 24, 2008, FDA published draft legislation
to reauthorize ADUFA, along with a proposal for a new user fee authority for generic animal drug
reviews. On July 8, 2008, bills were introduced in the House to reauthorize ADUFA (H.R. 6432)
and to establish a user fee program for generic animal drugs (H.R. 6433). Both bills were
forwarded without amendment to the full committee by the House Energy and Commerce
Subcommittee on Health the following day, and were marked up by the full committee on July
16, 2008. On July 30, 2008, the House passed H.R. 6432, as amended, under suspension. The
engrossed bill incorporated an amended version of H.R. 6432, as it was reported by the full
committee, and H.R. 6433, the proposal for generic animal drugs, as it was reported. On August
1, 2008, the Senate took up the House-passed measure and passed it by unanimous consent. The
measure has been sent to the President, who is expected to sign it.
Reauthorization of the existing user fee program was supported by animal drug research and
development companies, livestock producers, and the American Veterinary Medical Association.
Because a sunset of program authority would have been highly disruptive to the animal drug
review process, many supporters felt that ADUFA reauthorization was “must pass” legislation in
the 110th Congress. A coalition of consumer groups opposed the user fee program and its
reauthorization, however, citing concerns about the safety of animal drugs approved for livestock
production.

1

See comments of Dr. Richard Carnavale, Vice President for Scientific and Regulatory Affairs, Animal Health
Institute, at FDA public meeting on ADUFA reauthorization, March 11, 2008, at http://www.fda.gov/cvm/
ADUFA032008Transcript.htm. Many of these companies are members of the Animal Health Institute, the trade
association that represents their interests, at http://www.ahi.org/.
2
Many of these companies have formed the Generic Animal Drug Alliance, at http://www.fda.gov/cvm/
ADUFAIIPresBatliner.htm.
3
The law says that ADUFA user fee authority “shall not be in effect after October 1, 2008” (emphasis added). [21
U.S.C. § 379j-11 note].

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This report discusses aspects of ADUFA I, including funding and program performance; FDA’s
proposed changes for ADUFA II; FDA’s proposal for a new generic animal drug user fee
program; congressional activity; and relevant issues. Appendix A provides a summary of
ADUFA I. Appendix B describes the FDA process for approval of animal drugs. This report will
be updated to incorporate legislative actions and other events as they unfold. References in this
report to “the Secretary” refer to the Secretary of Health and Human Services (HHS).

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The Animal Drug User Fee Act of 2003 (ADUFA I, P.L. 108-130) established, for the first time,
effective in FY2004, authority for FDA to collect fees from sponsors of animal drugs in order to
reduce the backlog of application reviews for those products, and to decrease the time required
for future reviews. The act mirrored many provisions from the existing prescription drug and
medical device user fee programs.4 ADUFA authority is in sections 739-740 of the FFDCA [21
U.S.C. §§ 379j-11 and -12]. With the exception of one technical and one conforming amendment
in 2007, the law has not been amended since its original passage.5 ADUFA I authority sunsets
October 1, 2008, the beginning of the FY2009 fiscal year. A summary of the law is provided in
Appendix A.
The bills that were ultimately enacted in the 108th Congress were H.R. 1260 and S. 313. In its
report on the House bill, the House Committee on Energy and Commerce noted that in 1992,
FDA was required to report to Congress regarding the feasibility of a user fee program to improve
the review process for animal drugs.6 In 1994, FDA reported that inadequate review resources, a
growing workload, and low-quality applications submitted by industry had slowed the approval
process to an unacceptable rate. The FDA report noted that if Congress were to consider
legislation authorizing FDA to impose and collect user fees, approximately $11 million in fees
would be needed annually. The committee reported that as of 2003, the situation had not
improved, and may have worsened.
In its report on the Senate bill, the Senate Committee on Health, Education, Labor, and Pensions
said that animal drug user fee authority should allow FDA to (1) eliminate existing backlogs of
applications within two years; (2) over a five-year period, move toward the goal of completing
the review of 90% of new animal drug applications within 180 days; (3) resolve new and
emerging scientific issues that affect the ability of FDA to make approval decisions; and (4)
achieve an enhanced and predictable review performance.7

4

See CRS Report RL33914, The Prescription Drug User Fee Act (PDUFA): History, Reauthorization in 2007, and
Effect on FDA, by (name redacted), and CRS Report RL34571,
Medical Device User Fees and User Fee Acts, by (name re
dacted).
5
P.L. 110-85, The Food and Drug Administration Amendments Act of 2007, § 109, 121 Stat. 842, September 27, 2007.
6
H.Rept. 108-287, to accompany H.R. 1260, the Animal Drug User Fee Act of 2003, referring to P.L. 102-571, the
Prescription Drug User Fee Act of 1992, § 108(a).
7
S.Rept. 108-51, to accompany S. 313, the Animal Drug User Fee Act of 2003.

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ADUFA I authorizes the collection of user fees for the review of pioneer animal drugs, the socalled “(b)(1)” animal drugs. It does not authorize the collection of fees for ANADAs, the socalled “(b)(2)” generic animal drugs.8 The law requires the Secretary, to the extent practicable, to
segregate the review of ANADAs from that of NADAs, and adopt other administrative
procedures to ensure that review times of ANADAs do not increase because of activities under
the user fee program.

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ADUFA I defines the activities and costs that are allowable under the user fee program, including
those related to personnel, management of information and facilities, and fee collection, for the
review of applications.9 The definitions do not include any postmarket activities, and expressly
prohibit the use of user fees to review advertising and labeling after an animal drug has been
approved.

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Congress established, in ADUFA I, three funding “triggers” that prohibit FDA from collecting
user fees for animal drug review unless certain conditions are met each year. This was done to
ensure that user fees supplement, rather than replace, appropriated funds. Two of the triggers set
FY2003 as a baseline, a minimum level of non-user fee appropriations (adjusted for inflation) that
must be maintained each year. One of these triggers requires that this level be maintained across
the agency. The other requires that it be maintained specifically for animal drug review activities.
The third trigger prohibits FDA from collecting user fees unless an explicit amount for such fees
is authorized in annual appropriations. The triggers are as follows:
•

FDA’s overall appropriation for salaries and expenses for a given fiscal year,
excluding fees, must exceed the agency’s overall appropriation for salaries and
expenses for FY2003 (prior to the user fee program), excluding fees, and
adjusted for inflation.10

•

FDA must spend, for animal drug review, from appropriated funds, an amount
not more than 3% below the amount spent for animal drug review, from
appropriated funds, in FY2003 (prior to the user fee program), under certain
conditions. Under no condition may such amount be more than 5% below the
FY2003 amount. (Amounts in either case are adjusted for inflation).11

•

Fees shall be collected and available for obligation only to the extent and in the
amount provided in advance in annual appropriations acts.12

8

If safety or effectiveness data are required for a request to change an approved generic animal drug application (such
as approval for a new species) it is considered a supplemental animal drug application, and is subject to a user fee under
ADUFA.
9
FFDCA §§ 739(8) and (9) [21 U.S.C. §§ 379j-11(8) and (9)].
10
FFDCA § 740(f)(1), [21 U.S.C. § 379j-12(f)(1)].
11
FFDCA § 740(g)(2), [21 U.S.C. § 379j-12(g)(2)].
12
FFDCA § 740(g)(1), [21 U.S.C. § 379j-12(g)(1)].

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In its annual financial reports to Congress for fiscal years 2004 through 2006 (the most recent
available), as required by ADUFA I, FDA reports that each of the fee triggers was met each year.13

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Experience from the human drug and medical device user fee programs showed that because the
number of applications varies from year to year, basing a user fee program solely on application
fees did not provide predictable funding streams. From the outset, ADUFA I authorized several
types of user fees. The act also authorized the total revenues for each fee type that may be
collected each fiscal year, which are to be adjusted annually for inflation and workload. The act
required the Secretary to set annual fees at least 60 days before the start of each fiscal year and to
publish the fees and methodology in the Federal Register. The types of animal drug user fees, and
the fee amounts for FY2008, are as follows:
•

Application fees: One-time fees for new animal drug applications (NADAs), and
NADA supplements for which safety or effectiveness data are required.14
Supplement fees are half the amount of the NADA fee. The FY2008 amounts are
$172,500 per NADA and $86,250 for a NADA supplement for which safety or
effectiveness data are required.

•

Product fees: Annual fees for each of a sponsor’s products to which ADUFA is
applicable, including approved and pending applications. The FY2008 amount is
$4,125.

•

Establishment fees: Annual fees for each of a sponsor’s manufacturing
establishments, unless the product is not manufactured in the year the fee would
be assessed. The FY2008 amount is $52,700.

•

Sponsor fees: Annual fees for each sponsor of an approved or pending
application. The FY2008 amount is $43,900.15

Sponsor fees apply only if the sponsor has had, since September 1, 2003, a pending NADA,
NADA supplement or investigational new animal drug (INAD) submission. Product and
establishment fees apply only if the sponsor has had, since September 1, 2003, a pending NADA
or NADA supplement. ADUFA I establishes that total revenues for each type of fee should
comprise one-fourth of total fee revenues, but the actual proportion of each type of fee collected
each year typically varies slightly from these projections. FDA publishes information about fee
collections in its annual financial reports to Congress, as required by ADUFA I.

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ADUFA I authorizes the Secretary to waive or reduce fees if he determines that one or more of
the following applies:
•

Assessing the fee would be a barrier to innovation.

13

ADUFA reports are available at http://www.fda.gov/cvm/adufa.htm.
See Appendix B for a description of the FDA approval process for animal drugs.
15
ADUFA fee information is available at http://www.fda.gov/cvm/adufa.htm.
14

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•

Fees would exceed FDA’s present and anticipated future costs for conducting
reviews.

•

The application is intended solely for a minor reformulation of an approved drug
for use in animal feed.

•

The application is intended solely to provide for a minor use or minor species
indication.

•

The sponsor is a small business submitting its first animal drug application. The
law defines a small business as one having fewer than 500 employees, including
employees of affiliates.

Information about the numbers and value of waivers and reductions granted and used is provided
in FDA’s annual financial reports. The most common waivers granted were fees for sponsors of
approved or pending applications for minor use or minor species indications.

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ADUFA I performance goals were developed following consultation between FDA and the
regulated industry, primarily to address the backlog of animal drug reviews and to shorten review
times in the future. The goals were not incorporated in the statute, which instead refers to the
goals as identified in the Secretary’s letter to the chairmen and ranking members of the House
Committee on Energy and Commerce, and the Senate Committee on Health, Education, Labor,
and Pensions.16 Animal drug submissions to FDA vary considerably in their complexity. By
agreement between FDA and the industry, a subset of six submission types were chosen as being
the most meaningful for performance measurement, and are referred to as sentinel submissions.
Table 1 displays the performance goals that apply to the five-year ADUFA I performance period
of FY2004 through FY2008. FDA was to review and act on 90% of sentinel submissions within
the specified amounts of time. The goals were to be phased in to achieve progressive
improvements in the timeliness of review.

. ADUFA I Performance Goals

Table 1

FDA Review Time (days)
Activity
FY2004
FY2005
FY2006
FY2007
The goal is to review and act on 90% of submissions within the stated time.
administrative NADAs and
reactivations
Non-manufacturing supplemental NADAs
and reactivationsa
Manufacturing supplemental NADAs and
reactivationsb
Non-

FY2008

295

270

230

200

180

320

285

235

200

180

225

190

140

120

120

16

This letter, dated November 13, 2003, is published as an appendix in FDA’s annual ADUFA performance reports, at
http://www.fda.gov/cvm/adufa.htm.

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Activity
INAD submissions of study data
INAD submissions of study protocols
Administrative NADAs

Interim backlog goals

FY2004
320
125
90

FDA Review Time (days)
FY2005
FY2006
FY2007
285
100
85

235
80
80

200
60
70

FY2008
180
50
60

Review and act on pending applications, supplemental applications, and INAD submissions within 24 months of
initiation of user fee payments.

Additional interim goals

Fifty percent of FDA incremental review staff recruited and on board by first quarter of FY2006. Total staff increment
on board by end of FY2008.
FDA will review all submissions in accordance with procedures for working within a queue. An application/submission
that is not reviewed within the applicable time frame will be reviewed with the highest possible priority among those
pending.
a. Non-manufacturing supplemental applications are those that require safety and effectiveness data.
b. Manufacturing supplemental applications are typically less complicated, requiring data on manufacturing,
processing, packaging and related activities.
According to the required annual performance reports for FY2004 through FY2006 (the most
recent available), FDA says that all timeliness goals were met or exceeded during each year of
program performance. Also, the agency reports that, as proposed, the submission backlog was
eliminated by the end of FY2004, the goal of having 50% of additional review staff recruited and
on-board by the first quarter of FY2006 was met, improvements were made in staff training and
business systems, and several guidance documents were published.

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Section 512(c)(1) of the FFDCA requires FDA to review and act on abbreviated new animal drug
applications (ANADAs, which are generic animal drug applications) within 180 days of
submission.17 In congressional testimony in June 2008, FDA reported that in FY2007, the average
review time for ANADAs was 570 days, and there was a backlog of 446 of these submissions,
almost double the number in FY2000.18 The review of ANADAs is funded entirely through
appropriations. ADUFA user fee funds may not be applied to generic animal drug reviews.
The Secretary’s letter to congressional committees regarding ADUFA performance goals did not
address goals for the review of ANADAs. ADUFA I requires that the Secretary, to the extent
practicable, segregate the review of ANADAs from the process for user fee-funded reviews and
adopt other administrative procedures to ensure that review times for ANADAs do not increase as
17
The FDA must, within that time, either issue an order approving the application, or offer the sponsor a notice of
opportunity for hearing regarding the agency’s finding, pursuant to FFDCA §512(d)(1), of a basis for withholding
approval. See Appendix B for a description of the FDA approval process for animal drugs.
18
Testimony of Bernadette M. Dunham, Director, FDA CVM, before the House Committee on Energy and Commerce,
Subcommittee on Health, hearing on “Committee Prints on Administration Legislative Proposals on the Animal Drug
User Fee Act Amendments of 2008 and the Animal Generic Drug User Fee Act of 2008,” June 5, 2008, 110th Cong.,
2nd Sess., Washington, DC.

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a result of activities under the user fee program. The act also requires that FDA include, in its
annual performance reports to Congress, information about review times for ANADAs, and about
the required administrative procedures. The annual performance reports do not provide
quantitative information regarding ANADA submissions and review times. They note that FDA
maintains separate staffing and queues for ANADAs, and has defined baseline performance levels
from FY2001 through FY2003, against which to measure current performance. In its annual
performance reports, FDA says that ANADA review times did not increase in FY2004, but did
increase in FY2005 and FY2006, which the agency attributes to understaffing.
Table 2 compiles CVM workload data for the animal drug program overall (i.e., for both brandname and generic drugs) for FY2004 through FY2009, noting the numbers of submissions
received, completed, approved, and pending. It is not valid to directly compare program outputs
for ADUFA activities in Table 2 against the goals in Table 1. Table 2 does not present
information about review times, and it is not possible to know which submissions in Table 2
represent the sentinel submissions to which the performance goals are applied. Also, submissions
acted upon (or not) in a given year are not necessarily subsets of the number of submissions
received that year. Nonetheless, Table 2 (shaded rows) shows a steady increase in the number of
pending ANADA supplements and a decline in the number of them completed each year, neither
of which appears to be explained by the annual number of applications.

Table 2. Animal Drug Program Activities

Submission
FY2004
FY2005
FY2006
FY2007
type
actual
actual
actual
actual
Applications and activities covered by ADUFA I user fee authority
NADAs

FY2008
estimate

FY2009
estimate

Received
Completed
Approved
Pending

15
23
18
3

11
9
7
5

16
13
6
8

21
22
18
7

20
22
19
5

20
23
19
2

Received
Completed
Approved
Pending

408
476
356
156

451
449
319
159

598
561
430
195

605
610
496
187

605
618
540
174

605
627
540
152

Received
Completed
Pending

2,138
2,200
264

1,888
1,767
386

2,193
2,231
351

2,457
2,491
320

2,457
2,491
286

2,464
2,491
259

Received
Completed
Approved

61
55
19

49
46
13

45
43
17

23
37
20

24
35
18

27
32
18

NADA supplements

Investigational new animal drug (INAD) files

Applications and activities not covered by ADUFA I user fee authority
ANADAs

˜—›Žœœ’˜—Š•ȱŽœŽŠ›Œ‘ȱŽ›Ÿ’ŒŽȱ

ŝȱ

—’–Š•ȱ›žȱœŽ›ȱŽŽȱ›˜›Š–œȱ

ȱ

Submission
type

FY2004
actual

FY2005
actual

FY2006
actual

FY2007
actual

FY2008
estimate

FY2009
estimate

Pending

47

50

52

38

27

22

Received
Completed
Approved
Pending

211
195
163
78

116
97
71
99

127
120
80
104

142
88
71
157

143
86
69
214

149
82
69
281

Received
Completed
Pending

170
130
66

335
229
173

191
321
42

145
149
38

160
140
58

160
140
78

ANADA supplements

Generic investigational new animal drug (JINAD) files

Source: Annual FDA Congressional Budget Justifications, FY2006 through FY2009, Animal Drugs and Feeds
sections, Animal Drugs and Feeds Program Activity Data (PAD) tables.

›˜›Š–ȱž—’—ȱŠ—ȱ’—Š—Œ’Š•ȱŽ™˜›œȱ
ADUFA I authorized the following funding levels for its five-year program period, from FY2004
through FY2008, as follows:
•

$5 million for FY2004,

•

$8 million for FY2005, and

•

$10 million for each of fiscal years 2006 through 2008.

Each amount is subject to the inflationary and workload adjustments required by ADUFA I. The
Secretary also has authority, but is not required, to apply a final-year adjustment to the FY2008
amount, to provide up to three months of carryover into FY2009. An adjustment for the full three
months was included in the agency’s FY2008 budget request and was provided in the amount
authorized in FY2008 appropriations.
ADUFA I requires the Secretary to submit to Congress, within 120 days of the end of each fiscal
year, annual financial reports about the user fee program. FDA has published reports for fiscal
years 2004 through 2006.19 The reports address the three funding triggers, each of which has been
met each fiscal year. They also present total costs for the process of review of animal drug
applications, as defined in ADUFA I, and the amounts paid from user fee revenues and
appropriations. These costs are principally borne by FDA CVM, but also, to a lesser extent, by the
Office of the Commissioner (OC) and the Office of Regulatory Affairs (ORA). OC supports
general and administrative functions. ORA supports pre-approval inspections of manufacturing
facilities, investigations of clinical studies, and analytical testing of samples that are counted for
the review process for animal drug applications.

19

See http://www.fda.gov/cvm/adufa.htm.

˜—›Žœœ’˜—Š•ȱŽœŽŠ›Œ‘ȱŽ›Ÿ’ŒŽȱ

Şȱ

—’–Š•ȱ›žȱœŽ›ȱŽŽȱ›˜›Š–œȱ

ȱ

Table 3 presents the funding history for the ADUFA I program period of FY2004 through
FY2008, with FY2003 provided as a baseline. (FY2003 appropriations levels for animal drug
review serve as the baseline for one of the three funding triggers.) User fee funds have grown as a
proportion of total funding for animal drug review, accounting for almost one-fourth of total
funding in FY2006.20 Obligations from direct appropriations grew by about 12% overall between
FY2003 and FY2006. User fee revenues available during the ADUFA I program period totaled
almost $50 million, including the final year adjustment in FY2008 for carryover into FY2009.

. ADUFA I Funding History, FY2003-FY2008

Table 3

(dollars in thousands)

Fiscal Year

Obligations from Direct
Appropriationsa

FY2003

FY2004
FY2005
FY2006
FY2007
FY2008

$32,748
31,774c
34,408
36,637
not published
not published

User Fees/
User Feesb

Total

Total (%)

NA
5,000
8,354
11,318
11,604
13,696d

$32,748
36,774
42,762
47,955
NA
NA

0
13.6
19.5
23.6
NA
NA

Total: ADUFA I
NA
$49,972
NA
NA
Notes: NA is not applicable. User fees were first authorized for FY2004. FDA has published amounts obligated

to the animal drug review program from direct appropriations only for fiscal years 2003 through 2006. Annual
percentages and totals can be calculated only for those years for which there are published amounts for these
obligations.
ADUFA I does not have explicit requirements regarding full-time equivalent (FTE) staffing positions for animal
drug review, and FDA has not published information about these positions that is comparable from one fiscal
year to the next.
a. From FDA Annual ADUFA Financial Reports for FY2004 through FY2006, at http://www.fda.gov/cvm/
adufa.htm#Reports. Includes only direct appropriations, not user fee amounts specified in annual
appropriations acts.
b. Amounts as specified in annual appropriations acts.
c. Though this amount is less than the FY2003 baseline, this trigger in ADUFA I provides that FDA may collect
user fees as long as the amount obligated for animal drug reviews is not more than 3% below the FY2003
baseline, adjusted for inflation. Because of the 3% cushion, this requirement was met in FY2004.
d. Amount reflects, in addition to inflationary and workload adjustments, the final year adjustment, pursuant to
ADUFA I at FFDCA § 740(c)(3) [21 U.S.C. § 379j-12(c)(3)], for carryover into the first three months of
FY2009.

20
User fees made up a larger proportion of total funds available for human drug reviews during the same period. See
Table 2B in CRS Report RL33914, The Prescription Drug User Fee Act (PDUFA): History, Reauthorization in 2007,
and Effect on FDA, by (name redacted). User fees made up a smaller proportion of total funds for medical device reviews.
See Table 4 in CRS Report RL33981, Medical Device User Fee and Modernization Act (MDUFMA) Reauthorization,
by (name redacted).

˜—›Žœœ’˜—Š•ȱŽœŽŠ›Œ‘ȱŽ›Ÿ’ŒŽȱ

şȱ

ȱ

—’–Š•ȱ›žȱœŽ›ȱŽŽȱ›˜›Š–œȱ

ž—œŽȱ›˜Ÿ’œ’˜—ȱ
ADUFA I user fee authority sunsets October 1, 2008. FDA would have been prohibited from
collecting user fees after this date, unless the program were reauthorized.21 If not, absent other
sources of funds, the agency would have to lay off animal drug review staff.22 Personnel
regulations require that federal agencies give staff 60 days notice of an impending reduction in
force (RIF).23 In 2007, as similar authorities for human drugs and devices were about to sunset,
the FDA Commissioner expressed concern to Congress about the potential attrition of staff who
feared losing their jobs, and the desire to avoid having to send the required RIF notice.24

ȱ›˜™˜œŠ•ȱ˜›ȱȱŽŠž‘˜›’£Š’˜—ȱ
’–Ž•’—Žȱ
ADUFA I directs FDA to (1) develop a reauthorization proposal for fiscal years 2009 through
2013 (ADUFA II), in consultation with Congress and stakeholders; (2) publish its proposed
recommendations in the Federal Register; (3) hold a public meeting thereafter; (4) provide a 30day public comment period; and, finally, (5) present its final recommendations to the Congress.
On February 21, 2008, FDA published its proposal for ADUFA II, which was developed based on
a public meeting in April 2007 and discussions with the regulated industry.25 FDA held another
public meeting to present its proposal and receive comments on March 11, 2008. Written
comments were due to the agency on April 14, 2008. FDA’s legislative proposal to the Congress
was published on April 24, 2008.26

˜—Ž—ȱ
According to the Federal Register notice, FDA’s proposed reauthorization would maintain most
of the basic architecture of ADUFA I. The draft ADUFA II legislation, published on April 24,
2008, largely reflects the Federal Register proposal. Significant proposed changes to program
financing and performance goals are discussed in greater depth below.27 The agency’s proposal
21
ADUFA’s requirements for reports to Congress sunset 120 days later, which maintains the annual performance and
financial reporting requirement for FY2008, whether or not the program were reauthorized.
22
FDA estimated that 58 employees would have been affected by such layoffs. See Testimony of Bernadette M.
Dunham, Director, FDA CVM, before the House Committee on Energy and Commerce, Subcommittee on Health,
hearing on “Committee Prints on Administration Legislative Proposals on the Animal Drug User Fee Act Amendments
of 2008 and the Animal Generic Drug User Fee Act of 2008,” June 5, 2008, 110th Cong., 2nd Sess., Washington, DC.
23
See U.S. Office of Personnel Management, “Summary of Reduction in Force Under OPM’s Regulations,” at
http://www.opm.gov/rif/general/rifguide.asp.
24
See “FDA Chief Again Presses Congress On User Fees, Says 1997 Delay Caused Severe Setbacks,”
InsideHealthPolicy.com, September 17, 2007.
25
73 Federal Register 9571-9575, February 21, 2008.
26
FDA, “Animal Drug User Fees,” April 24, 2008, at http://www.fda.gov/oc/opacom/hottopics/adufa_agdufa/
adufareauth.html.
27
The reauthorization proposal also includes several technical changes. FDA has listed the differences between
ADUFA I and its ADUFA II legislative proposal at http://www.fda.gov/oc/opacom/hottopics/ADUFA_AgDUFA/
ADUFAIIsummary.html.

˜—›Žœœ’˜—Š•ȱŽœŽŠ›Œ‘ȱŽ›Ÿ’ŒŽȱ

ŗŖȱ

—’–Š•ȱ›žȱœŽ›ȱŽŽȱ›˜›Š–œȱ

ȱ

does not address matters related to postmarket activities. A separate proposal to establish a user
fee program for the review of generic animal drugs is discussed in a subsequent section of this
CRS report.

›˜›Š–ȱ’—Š—Œ’—ȱ
FDA says that user fees have not kept up with the increase in program costs that result from what
the agency calculates as 5.9% annual inflationary growth in pay and benefits, and rent and rentrelated costs, over the ADUFA I program period. The agency proposes higher levels of fee
revenues for the ADUFA II program period, above those that would result solely from the
inflation adjustments in current authority. Table 4 presents FDA’s proposed authorization levels
for ADUFA II fee revenues, based on the agency’s projections. The recommended levels total $98
million over five years, almost twice the funding level of the five-year ADUFA I program period
(see Table 3). FDA proposes to eliminate the current inflation adjustment provisions for fee
revenues (because such adjustments are incorporated in the proposed revenue targets), and
suggests a number of additional technical changes to fee authority. The agency proposes to leave
the current fee triggers unchanged throughout the ADUFA II program period.

Table 4. FDA Proposed ADUFA II Funding Levels,
FY2009-FY2013
(dollars in thousands)
Fiscal Year

FY2009

FY2010

FY2011

FY2012

FY2013

Total

Authorization of appropriations

15,260

17,280

19,448

21,768

24,244

$98,000

Source:

73 Federal Register 9571-9575, February 21, 2008.

—‘Š—ŒŽ–Ž—œȱ˜ȱŽ›˜›–Š—ŒŽȱ ˜Š•œȱŘŞȱ
FDA proposes to retain the same initial time frames for review throughout the ADUFA II program
period as those in place in FY2008 (see Table 1). Per discussions with industry, the agency
proposes to add an “end review amendment” process. It would allow the agency to work with
sponsors to make minor amendments to a submission, rather than designating the review as
incomplete, which “re-sets the clock” for an additional review cycle.29 Other proposals agreed to
by FDA and the industry include holding public workshops, implementing procedures to
streamline scheduling of foreign facility pre-approval inspections, and discussing the applicability
of pharmacokinetic and pharmacodynamic data in the review process, among others. In addition,
FDA proposes to develop an electronic tool for industry submissions and online review capability
within 24 months of an ADUFA appropriation for FY2009.

28

FDA has published its proposed performance goals and procedures for ADUFA reauthorization at
http://www.fda.gov/cvm/ADUFAIIreauthorization.htm.
29
The process is described in the transcript of the FDA public meeting on ADUFA reauthorization, March 11, 2008
(hereafter referred to as ADUFA meeting transcript), at http://www.fda.gov/cvm/ ADUFA032008Transcript.htm.

˜—›Žœœ’˜—Š•ȱŽœŽŠ›Œ‘ȱŽ›Ÿ’ŒŽȱ

ŗŗȱ

—’–Š•ȱ›žȱœŽ›ȱŽŽȱ›˜›Š–œȱ

ȱ

ȱ›˜™˜œŠ•ȱ˜›ȱ Ž—Ž›’Œȱ—’–Š•ȱ›žȱœŽ›ȱŽŽœȱ
Though ADUFA I required FDA to take steps to ensure that the user fee program did not
compromise the timeliness of generic animal drug reviews, FDA has had difficulty keeping up
with these reviews, and has not generally met the statutory requirement to act on ANADAs within
180 days. (See the earlier section on “Program Performance”.) It is not clear whether this is a
result of the user fee program, a result of a failure of non-fee funding to keep pace with demand
in the generics program (which may have occurred regardless of the user fee program), or other
factors. In its FY2009 budget request, FDA proposed, for the first time, a user fee program to
support reviews of generic animal drugs. At an ADUFA public meeting in 2007, a representative
of the Generic Animal Drug Alliance (GADA) announced the Alliance’s support for a generic
animal drug user fee program.30
On April 24, 2008, FDA published a draft legislative proposal for the Animal Generic Drug User
Fee Act (AGDUFA), accompanied by performance goals for generic animal drug review that
were agreed to in consultation with the industry.31 The agency noted the increasing review times
for generic animal drugs, saying that the workload was likely to grow, because patent protection
on approximately 49 animal drugs will expire between FY2009 and FY2011. The AGDUFA
proposal is similar in design to ADUFA I, including, for example, comparable fee triggers (one of
them requiring maintenance of non-user fee funding for generic animal drug reviews), fee-setting
requirements, workload adjustments, and reporting requirements. Like FDA’s ADUFA II
proposal, the AGDUFA proposal has fixed annual increases instead of the ADUFA I inflation
adjuster. Notable differences between ADUFA I and the AGDUFA proposal include the
following:
•

AGDUFA authority to collect application, product, and sponsor fees, but not
establishment fees.

•

AGDUFA sponsor fees (for which a given sponsor would pay only one fee per
year) that are tiered according to the number of a sponsor’s currently approved
ANADAs.

•

AGDUFA authority to waive or reduce fees only if the drug is intended for a
minor use or minor species indication.

Table 5 presents FDA’s proposed authorization levels for AGDUFA fee revenues for FY2009
through FY2013.

Table 5. FDA Proposed AGDUFA Funding Levels,
FY2009-FY2013
(dollars in thousands)
Fiscal Year

FY2009

FY2010

FY2011

FY2012

FY2013

Total

Authorization of appropriations

4,831

5,106

5,397

5,706

6,031

$27,071

30

Presentation of Stephanie Batliner, representing the Generic Animal Drug Alliance, ADUFA public meeting, April
27, 2007, at http://www.fda.gov/cvm/ADUFA07PM.htm.
31
FDA, “Animal Drug User Fees,” April 24, 2008, at http://www.fda.gov/oc/opacom/hottopics/adufa_agdufa/
adufareauth.html.

˜—›Žœœ’˜—Š•ȱŽœŽŠ›Œ‘ȱŽ›Ÿ’ŒŽȱ

ŗŘȱ

—’–Š•ȱ›žȱœŽ›ȱŽŽȱ›˜›Š–œȱ

ȱ

FDA, “Animal Drug User Fees,” April 24, 2008, at http://www.fda.gov/oc/opacom/hottopics/
adufa_agdufa/adufareauth.html.
Source:

FDA’s proposed performance goals for AGDUFA are similar to those for ADUFA I. The agency
proposes to review and act on 90% of five “sentinel” types of generic animal drug submissions
within specific time frames, which decrease steadily from FY2009 through FY2013. (As noted
earlier, FFDCA §512(c)(1) requires the FDA to act on all such submissions within 180 days.) In
FY2009, the proposed target to act on certain submissions is as long as 700 days (almost two
years). By FY2013, the longest proposed target is 270 days. The agency did not propose any
AGDUFA performance goals regarding the backlog of reviews, or other matters.
In congressional testimony in June 2008, a witness representing GADA testified that according to
its agreement with FDA regarding an animal generic drug user fee program (as reflected in FDA’s
AGDUFA proposal), “the performance goals for AGDUFA do not return generic application
review times to [the statutory requirement of 180 days]. Rather, 270 days is the highest level of
performance that the generic animal drug industry could afford.”32

˜—›Žœœ’˜—Š•ȱŒ’˜—ȱ
ŽŠ›’—œȱ
On June 5, 2008, the House Energy and Commerce Subcommittee on Health held a hearing on
ADUFA reauthorization and the Administration’s ADUFA II and AGDUFA proposals.33
Subcommittee Members in attendance expressed a number of points of view regarding the
forthcoming legislative process. While all of them expressed general support for both proposals,
some stated a preference for efficient passage of a “clean” ADUFA reauthorization, while others
suggested that one or the other proposal could serve as a vehicle for additional subject matter that
was not part of the FDA-industry agreements. Such subject matter included postmarket safety—
in particular, public health concerns about antimicrobial resistance—and certain expansions of
FDA’s enforcement authority that are currently under consideration in the House and Senate.
These matters are discussed in greater detail in the next section of this CRS report, “Issues for
Congress”.

Ž’œ•Š’˜—ȱ
ŸŽ›Ÿ’Ž ȱ
On July 8, 2008, bills were introduced in the House to reauthorize ADUFA (H.R. 6432) and to
establish a user fee program for generic animal drugs (H.R. 6433). Both bills were forwarded
without amendment to the full committee by the House Energy and Commerce Subcommittee on
Health on July 9, and marked up and passed by the full committee on July 16. On July 30, 2008,
32
Testimony of Stephanie Batliner, representing GADA, before the House Committee on Energy and Commerce,
Subcommittee on Health, hearing on “Committee Prints on Administration Legislative Proposals on the Animal Drug
User Fee Act Amendments of 2008 and the Animal Generic Drug User Fee Act of 2008,” June 5, 2008, 110th Cong.,
2nd Sess., Washington, DC, hereinafter referred to as House Subcommittee hearing.
33
House Subcommittee hearing.

˜—›Žœœ’˜—Š•ȱŽœŽŠ›Œ‘ȱŽ›Ÿ’ŒŽȱ

ŗřȱ

—’–Š•ȱ›žȱœŽ›ȱŽŽȱ›˜›Š–œȱ

ȱ

the House passed H.R. 6432, as amended, under suspension. The engrossed bill incorporated an
amended version of H.R. 6432 (ADUFA reauthorization) as reported, and H.R. 6433 (AGDUFA),
as reported. On August 1, 2008, the Senate took up the House-passed measure, and passed it by
unanimous consent. The measure has been sent to the President, who is expected to sign it.

˜žœŽȱŒ’˜—ȱ
H.R. 6432, the Animal Drug User Fee Amendments of 2008, as introduced, would reauthorize
ADUFA, largely in line with FDA’s proposal. Rather than the inflation adjuster in current law, the
bill would authorize a total of $98 million for the program over the five-year period from FY2009
through FY2013, as requested by FDA and depicted in Table 4. The bill would extend, among
other provisions, (1) existing authority for the collection of application, product, establishment,
and sponsor fees (with authority to collect larger aggregate amounts of each type of fee in each
successive fiscal year); (2) the fee triggers; and (3) requirements for annual fiscal and
performance reports. Program authority would sunset on October 1, 2013, and reporting
requirements would sunset four months later, on January 31, 2014. The bill would not explicitly
establish performance goals. Rather, it refers in a finding to goals as laid out in a letter from the
Secretary to the Congress. Upon the bill’s passage, such a letter would presumably be included in
the Congressional Record as stated in the finding, and comport with the goals as published by
FDA in its reauthorization proposal,34 unless the goals were modified during passage.
H.R. 6432, as introduced, contains two provisions that were in neither ADUFA I nor the FDA
reauthorization proposal. The first are new requirements for public involvement in the
reauthorization planning that would begin prior to the FY2013 sunset. Provisions in Section 4 of
the bill would require the Secretary to (1) seek public input before beginning negotiations with
industry to reauthorize the program; (2) hold periodic consultations with other stakeholder groups
(e.g., consumer representatives) during such negotiations; and (3) publish transcripts of all
negotiation meetings between the FDA and the regulated industry. These requirements would be
in addition to the current requirement to seek public input at the conclusion of negotiations with
industry. The second new provision, in Section 5 of the bill, would alter the reporting period for
required drug experience reports (i.e., reports that companies must make to FDA if they are aware
of a product problem or defect), as currently required by regulation. The bill, as introduced,
would not authorize FDA to use program fees for postmarket activities, and would not establish
any new data reporting requirements for industry.
H.R. 6433, the Animal Generic Drug User Fee Act of 2008, as introduced, would establish a new
animal generic drug user fee program, largely in line with FDA’s proposal. The bill would
establish authority to collect application, product, and tiered sponsor fees (but not establishment
fees), and would establish fee triggers, fee-setting requirements, workload adjustments, and
reporting requirements. Rather than using an inflation adjuster, the bill would authorize a total of
about $27 million for the program over the five-year period from FY2009 through FY2013, as
requested by FDA and depicted in Table 5. Program authority would sunset on October 1, 2013,
and reporting requirements would sunset four months later, on January 31, 2014. As with H.R.
6432, the generics bill would not explicitly establish performance goals, but refers to such goals
in a finding.35 Also as with H.R. 6432, the bill would require the Secretary to seek public input
34
FDA has published its proposed performance goals and procedures for ADUFA reauthorization at
http://www.fda.gov/cvm/ADUFAIIreauthorization.htm.
35
FDA has published its proposed performance goals and procedures for AGDUFA at http://www.fda.gov/oc/opacom/
(continued...)

˜—›Žœœ’˜—Š•ȱŽœŽŠ›Œ‘ȱŽ›Ÿ’ŒŽȱ

ŗŚȱ

—’–Š•ȱ›žȱœŽ›ȱŽŽȱ›˜›Š–œȱ

ȱ

before beginning negotiations with industry to reauthorize the program, hold periodic
consultations with other stakeholder groups during such negotiations, and publish transcripts of
all negotiation meetings between the FDA and the regulated industry, in addition to a requirement
to seek public input at the conclusion of negotiations with industry. Finally, as with H.R. 6432,
the bill, as introduced, would not authorize FDA to use program fees for postmarket activities,
and would not establish any new data reporting requirements for industry.
Both H.R. 6432 and H.R. 6433 were marked up and passed by the full House Energy and
Commerce Committee on July 16, 2008. The committee amended H.R. 6432 (ADUFA
reauthorization) to make several technical and minor changes, and two substantive changes. First,
animal drug sponsors would be required to provide annual reports to FDA regarding any of their
animal drugs that contain an antimicrobial active ingredient. Such reports must include specified
information about drug distribution, proposed usage, and other matters, and the Secretary would
be required to publish such information in a manner that is consistent with national security and
business confidentiality concerns. Second, the Secretary would be required to refuse admission to
any imported animal drug that appears to be counterfeit, and to destroy any such items, under
certain conditions.36 H.R. 6433 was amended to make several technical and minor changes, but
no substantive changes.
On July 30, 2008, the House passed an amended version of H.R. 6432 under suspension of the
rules. The engrossed (House-passed) version of H.R. 6432 incorporated, as Title I, an amended
version of the H.R. 6432 ADUFA reauthorization bill that was reported by the full Energy and
Commerce Committee, and, as Title II, all provisions of H.R. 6433 (AGDUFA) as reported,
without any substantive changes. The provisions in House-passed Title I of the bill had been
amended to remove the earlier amendment made by the full committee regarding refusal of
admission and destruction of animal drugs that appear to be counterfeit. The earlier amendment
regarding reporting of information regarding animal antimicrobial drugs was retained. The
House-passed bill also contained, as Title III, two technical corrections to the Food and Drug
Administration Amendments Act of 2007 (FDAAA, P.L. 110-85) that do not apply to animal
drugs.

Ž—ŠŽȱŒ’˜—ȱ
On August 1, 2008, the Senate took up the engrossed (House-passed) version of H.R. 6432
(including reauthorization of ADUFA, the user fee program for generic animal drugs, and the
FDAAA technical corrections) and passed it by unanimous consent. The measure has been sent to
the President, who is expected to sign it.

œœžŽœȱ˜›ȱ˜—›Žœœȱ
This section discusses issues germane to congressional consideration of ADUFA reauthorization
and the establishment of a user fee program for generic animal drugs. Actual consideration of

(...continued)
hottopics/ADUFA_AgDUFA/AgDUFAperfgoals.html.
36
This provision would amend FFDCA § 801(a) [21 U.S.C. § 381(a)] regarding imports.

˜—›Žœœ’˜—Š•ȱŽœŽŠ›Œ‘ȱŽ›Ÿ’ŒŽȱ

ŗśȱ

ȱ

—’–Š•ȱ›žȱœŽ›ȱŽŽȱ›˜›Š–œȱ

these issues in moving legislation is tracked in the previous section of this CRS report,
“Congressional Action”.

ȱ›˜›Š–ȱŽ›˜›–Š—ŒŽřŝȱ
Generally, companies that research and develop animal drugs have been satisfied that ADUFA I
has eliminated the review backlog for brand-name animal drugs, improved the timeliness and
predictability of reviews, and improved communication with FDA throughout the process. The
industry’s focus for ADUFA II was to continue the enhancement of FDA review capacity,
including more support for increasingly complex reviews. Also, at the public meeting in March
2008, both FDA and industry speakers discussed a growing backlog of premarket inspections of
foreign animal drug producing facilities, which has not been remedied by the current user fee
program.

ȱ›˜›Š–ȱ˜œœȱ
The centerpiece of FDA’s reauthorization proposal, as negotiated with industry, was an increase
in user fee revenues to reflect cost growth in excess of authorized inflationary adjustments.38 The
proposal would authorize FDA to collect almost twice as much in animal drug user fees during
the five-year ADUFA II program period (FY2009 through FY2013) as it could during ADUFA I
(FY2004 through FY2008). Much of the growth in program costs that FDA cited is driven by
factors outside of the agency’s control, such as growth in the costs of employee salaries and
benefits, and rents.39
Although a backlog of premarket foreign facility inspections was discussed at the March 2008
public meeting, the FDA proposal did not explicitly address the cost of these inspections. Given
recent concerns about the safety of imported drugs and foods, FDA has been under pressure to
expand its oversight of foreign facilities that manufacture products it regulates. FDA has not,
however, signaled any particular safety concern about foreign plants that manufacture animal
drugs, or any changes to the premarket inspections of these plants that are conducted for purpose
of application review. At present, establishment fees may be assessed for these plants, when
applicable, but the fees are not directly linked to inspection costs, and do not distinguish between
domestic and foreign facilities.

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The aim of drug user fees programs is to speed the evaluation of drugs for safety and
effectiveness, without shortchanging the rigor of the evaluation or compromising the actual safety
and effectiveness of approved drugs. Critics have charged that the user fee program for human
drugs (PDUFA) places too much influence in the hands of industry, and speeds drugs to market
37

See public comments of Dr. Steven D. Vaughn, Director of FDA/CVM/ONADE, and Dr. Richard Carnavale, Vice
President for Scientific and Regulatory Affairs, Animal Health Institute, ADUFA meeting transcript.
38
See public comments of Gary Claywell, Deputy Director, FDA/CVM Office of Management, ADUFA meeting
transcript.
39
Claywell notes that pay and benefit costs grew by 5.9% annually over the ADUFA I program period, while
appropriations grew by 2.6%.

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with inadequate safety review. They note that the industry is actively involved in establishing
performance benchmarks, for example. Also, some feel that consumer confidence in FDA’s
review process is important, and that a perception of conflicts in the user fee programs may
undermine this confidence.40
It has been difficult to measure the effect of PDUFA, if any, on the safety of human drugs, and
unequivocal evidence of such an effect is lacking. The law has, since its second reauthorization,
allowed FDA to carry out certain postmarket safety activities with user fee funds. ADUFA I does
not have a comparable authority. No postmarket activities are listed in the definition of activities
for which fees may be used.41 For animal drugs, postmarket safety concerns arise on occasion,
resulting in withdrawals or label warnings, but noteworthy recent examples preceded ADUFA.
FDA’s proposal for ADUFA II, as negotiated with industry, did not seek authority to use animal
drug user fees for any postmarket activities. It is reported that during ADUFA reauthorization
negotiations, FDA sought to have authority to spend user fees on some postmarket antimicrobial
resistance activities (discussed further below), but drug companies objected.42

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Concerns about the effects of ADUFA on animal drug safety often play out in a different context
than that for the safety of human drugs. Some critics of the law are concerned about the safety of
drugs approved for animal agriculture with respect to public health and the environment, rather
than safety for the treated animal. In particular, they are concerned about antimicrobials (e.g.,
antibiotics) used in food-producing animals, and the risk of transmitting antimicrobial resistant
infections to people through food.43 In general, animal drug companies and livestock producers
are concerned that overly stringent regulation of this class of animal drugs could compromise
their availability and have harmful effects on animal health without an attendant public health
benefit.
FDA has asserted that there is a preponderance of evidence that the use of antimicrobials in foodproducing animals has adverse public health consequences, and that there is little evidence to the
contrary.44 In 2003, FDA published guidance for industry, laying out the agency’s information
requirements and processes for evaluating animal antimicrobial drugs that may pose this risk.45
40

See CRS Report RL33914, The Prescription Drug User Fee Act (PDUFA): History, Reauthorization in 2007, and
Effect on FDA, by (name redacted).
41
FFDCA §§ 739(8) and 739(9).
42
See “Antibiotic Measures That Were Axed From ADUFA May Still Be Included,” InsideHealthPolicy.com, July 9,
2008.
43
Antimicrobial resistance occurs when microbes—usually bacteria, though resistance can also be seen in viruses,
fungi, and parasites—are able to resist the effects of antimicrobial drugs in stopping microbial growth and
reproduction. Microbes have a number of mechanisms to resist antimicrobial drug effects. These mechanisms are often
coded in microbial genes, may be transferred between microbes, and often proliferate when microbes are exposed to
antimicrobial drugs. Antibiotics are a type of antimicrobial drug. For background, see the section “Antimicrobial
Resistance,” in CRS Report RL31853, Food Safety Issues in the 109th Congress, by (name redacted).
44
FDA presents its rationale in its comments on a 2004 Government Accountability Office (GAO) report, “Antibiotic
Resistance: Federal Agencies Need to Better Focus Efforts to Address Risk to Humans from Antibiotic Use in
Animals,” GAO-04-490, April 2004, pp. 88-94.
45
FDA, “FDA Issues Guidance on Evaluating the Safety of Antimicrobial New Animal Drugs to Help Prevent Creating
New Resistant Bacteria,” news release, October 23, 2003, at http://www.fda.gov/bbs/topics/NEWS/2003/
NEW00964.html.

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Review of this class of animal drugs may be more complex than is typical. FDA has not,
however, published information about submissions, review times, outcomes, costs, or other
metrics specific to this class.
A coalition of consumer groups opposed reauthorization of ADUFA, but in the event of its
reauthorization, called for it to authorize the use of ADUFA funds for the following postmarket
activities related to antimicrobial resistance: safety reviews of currently approved antimicrobial
drugs, the collection of veterinary drug use data to support antimicrobial risk assessments, and
enhanced surveillance for antimicrobial resistance related to animal drug use.46

46

See public comments of Brise Tencer, the Keep Antibiotics Working Coalition, ADUFA meeting transcript, and
“Advocates Want Animal Drug User Fees Spent on Post-Market Safety,” FDA Week, April 18, 2008. Groups in the
Coalition include Center for Science in the Public Interest, Food Animal Concerns Trust, Humane Society of the
United States, and Union of Concerned Scientists, among others. The coalition’s comments of April 14, 2008,
regarding ADUFA reauthorization are available at http://www.keepantibioticsworking.org/new/
resources_library.cfm?RefID=102290.

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™™Ž—’¡ȱǯ ž––Š›¢ȱ˜ȱ›˜Ÿ’œ’˜—œȱ’—ȱȱ ȱ
Provision

FFDCA
Section

U.S.C. Section
(Title 21)

Definitions
Types of fees

§ 739
§ 740(a)

§ 379j-11
§ 379j-12(a)

Total fee revenues

§ 740(b)

§ 379j-12(b)

Fee adjustments

§ 740(c)

§ 379j-12(c)

Fee waivers and
reductions

§ 740(d)

§ 379j-12(d)

Effect of failure to
pay fees

§ 740(e)

§ 379j-12(e)

Assessment of fees
(one fee trigger)

§ 740(f)

§ 379j-12(f)

Appropriations
authority (two fee
triggers)

§ 740(g)

§ 379j-12(g)

Collection of
unpaid fees

§ 740(h)

§ 379j-12(h)

Ȭŗşȱ

Table A-1. Summary of Provisions in ADUFA I
Summary
Defines covered types of applications, sponsors, processes, allowable activities, and other matters.
Requires the Secretary to collect animal drug user fees for applications, products, establishments, and product
sponsors. Establishes requirements regarding payment, refunds, and exceptions.
Establishes the total revenues (not the individual fees) that may be collected for each type of fee above, for each fiscal
year from FY2004—FY2008.
Requires the Secretary to make annual adjustments to total fee revenues based on inflation and workload. The
workload adjustment shall not result in annual revenues lower than those authorized in subsection (b), adjusted for
inflation. Requires the Secretary to establish annual fees 60 days prior to the start of each fiscal year, and publish final
fees and methodology in the Federal Register. Authorizes the Secretary, if necessary for FY2008, to set revenues
sufficient for up to three months of operating reserve, for carryover into the first three months of FY2009. Prohibits
the Secretary from collecting total annual revenues that exceed total annual costs.
Requires the Secretary to grant fee waivers or reductions if he finds that (1) fees would hinder innovation; (2) fees
would exceed review costs; (3) the application is solely for a minor reformulation of an approved drug for use in
feed; (4) the application is solely for a minor use or minor species indication; or (5) the sponsor is a small business
(an entity with fewer than 500 employees, including employees of affiliates) submitting its first animal drug application.
Establishes additional requirements regarding the small business waiver.
Establishes that for non-payment of fees after 30 days of their due date, pending applications, supplements and
investigational animal drug submissions shall be considered incomplete, and the Secretary may discontinue their
review.
Prohibits the collection of fees unless FDA salaries and expenses for a given fiscal year, excluding fees, are at least
equal to appropriations for FDA salaries and expenses for FY2003, excluding fees and multiplied by the applicable
adjustment factor. Does not require the Secretary to modify assessed fees if this trigger is met part-way through a
fiscal year.
Authorizes the collection of fees only if authorized in advance in annual appropriations. Such amounts are available
until expended. Authorizes the collection of fees only if FDA spends, for the review of animal drugs, at least as much
as it spent for this purpose from appropriations in FY2003, adjusted for inflation, unless the amount is within
specified limits. Authorizes appropriations for fees for FY2004—FY2008, and provides that fees collected in excess of
annual amounts authorized may be carried over and subtracted from future fee authority.
Establishes that if assessed fees are not paid within 30 days after they are due, such fees shall be treated as a claim of
the United States Government subject to 31 U.S.C. §§ 3711 et seq.

ȱ

FFDCA
Section

U.S.C. Section
(Title 21)

Waivers and
reductions
Rule of
construction

§ 740(i)

§ 379j-12(i)

§ 740(j)

§ 379j-12(j)

ANADAs (generic
animal drugs)

§ 740(k)

§ 379j-12(k)

Reauthorization:
consultation and
recommendations
Required reports
Sunset provisions

NA

§ 379j-11 note

NA
NA

§ 379j-11 note
§ 379j-11 note

Provision

ȬŘŖȱ

Summary
Requires that requests for consideration for fee waivers, reductions or refunds be submitted to the Secretary in
writing not later than 180 days after such fee is due.
States that this section may not be construed to require that the number of full-time equivalent positions in HHS, for
officers, employees, and advisory committees not engaged in the process of the review of animal drug applications, be
reduced to offset the number of officers, employees, and advisory committees so engaged.
Requires the Secretary: (1) to the extent practicable, to segregate the review of ANADAs from the process for the
review of NADAs; and (2) to adopt other administrative procedures to ensure that review times of ANADAs do not
increase due to activities under the user fee program.
Requires the Secretary, in developing recommendations to Congress for reauthorization after FY2008, to consult
with Congress and applicable stakeholder groups, publish recommendations in the Federal Register, hold a public
meeting, and seek public comment.
Requires the Secretary to report to Congress annually regarding program performance and funding.
Establishes that provisions in FFDCA § 740 shall not be in effect after October 1, 2008, and that provisions regarding
reauthorization consultation and required reports shall not be in effect after 120 days after such date.

ȱ

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Like human drugs, animal drugs must be shown to be safe and effective before they can be
marketed. The FDA Center for Veterinary Medicine (CVM), Office of New Animal Drug
Evaluation (ONADE), is responsible for the premarket review of new animal drugs, and it grants
approvals when requirements have been met. (CVM also regulates veterinary devices but does
not require their premarket approval. Veterinary biologics are regulated by the U.S. Department
of Agriculture.48)
Specific statutory requirements for the approval of “new animal drugs” are found in the Federal
Food, Drug, and Cosmetic Act (FFDCA), section 512 [21 U.S.C. § 360b]. Specific regulations are
primarily at 21 C.F.R. 510, et seq. In each case, general provisions also apply, such as labeling
requirements and enforcement provisions. According to CVM, virtually all animal drugs meet the
FFDCA definition of “new animal drug.”49 The term does not, as it may sound, distinguish
between pioneer (i.e., brand-name) and generic animal drugs. Several application names and
acronyms used in the animal drug approval process derive from the term “new animal drug.”
These names and acronyms are described in Table B-1 and discussed below. In this report, the
terms “animal drug” and “new animal drug” are used interchangeably. Requirements for the
approval of pioneer animal drugs begin at FFDCA section 512(b)(1), and those for the approval
of generic animal drugs begin at FFDCA section 512(b)(2). The respective products are often
referred to as “(b)(1)” or “(b)(2)” animal drugs.

47

Information in this section is drawn from Carol J. Haley, “The Minor Use and Minor Species Animal Health Act:
Past, Present and Future,” Food and Drug Law Journal, vol. 61, pp. 13-43, 2006 (hereafter referred to as Haley MUMS
article), and Steven D. Vaughn, FDA/CVM “Overview of the Animal Drug Approval Process,” undated presentation, at
http://www.fda.gov/cvm/nadaappr.htm.
48
See FDA CVM, “How FDA Regulates Veterinary Devices,” May 2003, at http://www.fda.gov/cvm/
regofdevices.htm. Veterinary biologics (e.g., vaccines and clinical laboratory tests) are regulated by the U.S.
Department of Agriculture (USDA), Animal and Plant Health Inspection Service, Center for Veterinary Biologics, at
http://www.aphis.usda.gov/animal_health/vet_biologics/. For more information about CVM activities, see “Animal
Drugs and Feeds” in CRS Report RL34334, The Food and Drug Administration: Budget and Statutory History,
FY1980-FY2007, coordinated by (name redacted).
49
“New animal drug” is defined at FFDCA § 201(v) [21 U.S.C. § 321(v)].

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.Terms Used in the Animal Drug Approval Process

Table B-1

Term
Investigational New
Animal Drug (INAD)
New Animal Drug
Application (NADA)
Administrative NADA
Generic Investigational
New Animal Drug
(JINAD)
Abbreviated New Animal
Drug Application
(ANADA)
Veterinary Master File
(VMF)
Supplemental application

Description

A pioneer animal drug for which a sponsor seeks approval pursuant to FFDCA section
512(b)(1). The term is commonly used to refer to the information file that is developed
for review.
Formal application to FDA for approval of a pioneer animal drug. Refers to the entire
process. Review is typically conducted in stages.
The final step in applying to FDA for approval of a pioneer animal drug, in which
summaries of stepwise reviews and other materials are presented.
A generic animal drug for which a sponsor seeks approval pursuant to FFDCA section
512(b)(2). The term is commonly used to refer to the information file that is developed
for review.
Formal application to FDA for approval of a generic animal drug.
A voluntary submission to FDA of confidential information about facilities, processes, or
articles used in the manufacturing, processing, packaging, and storing of animal drugs,
which FDA may use in evaluating applications. Comparable to a Drug Master File (DMF)
for human drugs.
Filed by sponsors seeking changes in the conditions of an existing approved NADA or
ANADA. Requested changes may be significant (e.g., a new species or indication) or
routine (e.g., product manufacturing changes).

The animal drug approval process is generally similar to that for human drugs, devices, and many
biologics.50 Animal drug sponsors conduct discovery research on drug candidates, including pilot
studies of dose and potential toxicity. Sponsors seeking to develop a promising drug candidate (an
Investigational New Animal Drug, or INAD) submit relevant information to CVM. Usually, the
process begins with a sponsor’s request for an exemption, pursuant to FFDCA section 512(j), to
allow for the interstate shipment of the unapproved product in order that clinical trials of the
drug’s safety and effectiveness may be conducted. Sponsors wishing to begin the FDA approval
process for an INAD submit a New Animal Drug Application (NADA) to CVM.
CVM generally conducts phased review of animal drugs, encouraging sponsors to submit
information about a product as it becomes available, rather than all at once, and to maintain
ongoing consultations with CVM about technical and other requirements. Technical requirements
include (1) the demonstration of safety in the target species, as well as in the environment and in
humans (including those handling and administering the drug, and those consuming the products
of food-producing animals, if applicable); (2) the demonstration of effectiveness in the target
species; and (3) matters regarding manufacturing methods, controls, and product stability.
When all required information is available, sponsors submit a final “Administrative NADA,”
containing agency sign-off letters for all phases of review, a labeling proposal, and other
information. An approved NADA means the product is safe and effective for its intended use, and
50

See “FDA Approval of New Drugs,” in CRS Report RL32797, Drug Safety and Effectiveness: Issues and Action
Options After FDA Approval, by (name redacted); “Background: FDA and Medical Device Regulation,” in CRS Report
RL34571, Medical Device User Fees and User Fee Acts, by (name redacted); and “Regulatory Framework,” in CRS
Report RL34045, FDA Regulation of Follow-On Biologics, by (name redacted).

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that the methods, facilities, and controls used for the manufacturing, processing, and packaging of
the drug are adequate to preserve its identity, strength, quality, and purity. As with approved
human drugs, sponsors of approved NADAs are required to notify FDA regarding an approved
drug’s postmarket performance, including any adverse events.
The animal drug approval process differs from the process for human products in two important
ways. First, to support the requirement for demonstration of safety in humans, if an animal drug is
intended for use in a food-producing animal, the sponsor must develop methods to test for drug
residues in the human food product (e.g., meat, milk, eggs, honey). FDA determines whether the
drug can be used safely in food-producing animals, with respect to public health. If approved, the
drug’s label must address a “withdrawal time” if necessary (i.e., a period of time that the drug
must be withheld before an animal’s products can be marketed for human consumption), allowing
drug residues to fall below levels of concern.51
Second, although CVM requires clinical trials to demonstrate an animal drug’s safety and
effectiveness, these trials are, necessarily and as a matter of regulation, somewhat different from
clinical trials required for the approval of human drugs. An approved animal drug may be labeled
for use only in the species for which trials were conducted. However, veterinarians are permitted,
under certain conditions, to use approved drugs for unapproved uses—so-called “extra-label”
uses—such as use in species other than those on the label, or for indications other than those on
the label.52 Also, clinical trials for animal drug approval need not be as extensive as trials for
human drugs. Among other things, initial testing of the animal drug may begin in the target
species, whereas candidate human drugs are studied to determine their safety in animals first,
before human trials are begun.
CVM also has authority to approve generic animal drugs.53 Sponsors seeking approval of a
Generic Investigational New Animal Drug (JINAD) must submit an Abbreviated New Animal
Drug Application (ANADA). The generic product and its uses must be the same as those of an
approved animal drug, with certain exceptions, and it must be demonstrated that the generic
product is bioequivalent to the approved product.54 Holders of approved or pending NADAs must
submit certain patent information to CVM. CVM publishes patent information on approved
NADAs, and requires ANADA applicants to certify that their product would not infringe upon a
current patent, or that any such current patent is invalid. Sponsors seeking to market a generic
version of an approved animal drug for a substantially different use than that currently approved
(such as a label indication for a new species) often must conduct clinical trials, and typically need
an investigational exemption pursuant to FFDCA section 512(j) in order to ship the drug
interstate.

51

These levels are called tolerances and are established for each approved drug by FDA, using information submitted
in the application, and from other sources.
52
P.L. 103-396, The Animal Medicinal Drug Use Clarification Act (AMDUCA), 1994. AMDUCA also authorized
veterinarians to use approved human drugs in animals. Certain restrictions of extra-label use apply to the use of drugs
in food-producing animals.
53
P.L. 100-670, The Generic Animal Drug and Patent Term Restoration Act, 1988.
54
See FDA/CVM information at http://www.fda.gov/cvm/gadaptra.html.

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Finally, CVM has authority for the conditional approval of drugs to treat minor animal species
(e.g., fish) and uncommon diseases in major animal species. This allows sponsors to market a
drug before collecting all necessary effectiveness data, but after proving that the drug is safe.55

ž‘˜›ȱ˜—ŠŒȱ —˜›–Š’˜—ȱ
(name redacted)
Specialist in Public Health and Epidemiology
[redacted]@crs.loc.gov, 7-....

55
P.L. 108-282, The Minor Use and Minor Species (MUMS) Animal Health Act, 2004. For more information on minor
uses and minor species, see Haley MUMS article and FDA/CVM information at http://www.fda.gov/cvm/
minortoc.htm.

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/crs%3ARL34459. Public record. Not legal advice.