Direct-to-Consumer Advertising of Prescription Drugs

Congressional research reportMar 25, 2005

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Direct-to-Consumer Advertising

of Prescription Drugs

March 25, 2005

Donna U. Vogt

Specialist in Social Legislation

Domestic Social Policy Division

Congressional Research Service ˜ The Library of Congress

Direct-to-Consumer Advertising of Prescription Drugs

Summary

The Direct-to-Consumer (DTC) advertising of prescription drugs by

pharmaceutical companies has been described as any promotional effort with respect

to these drugs that targets the general public through the lay media. Spending by the

drug industry on DTC advertising grew from $791 million in 1996 to $3.2 billion in

2003, mostly for promotion of 50 brand-name drugs. There is a growing consensus

among health professionals and others that DTC advertising may have exacerbated

recent problems with drug safety (e.g., Vioxx) and that it may contribute to the rising

cost of health care.

Drug manufacturers claim that DTC advertising reminds patients to visit their

doctors and be tested for health problems earlier, to take their medicines as

prescribed, and to become more involved in their own treatment. Some physicians

acknowledge that DTC advertising serves as an effective tool for conveying health

information to their patients. Others, however, mistrust DTC advertising because,

in their opinion, the information provided by the ads can sometimes be misleading.

From their perspective, DTC ads rarely, if ever, discuss non-drug forms of treatment,

such as weight control and other beneficial lifestyle changes.

In 1962, Congress gave the Food and Drug Administration (FDA) the authority

to regulate prescription drug advertising, which, at the time, consisted primarily of

ads in medical journals directed mostly toward physicians. The law prohibited FDA

from issuing regulations that would require prior approval of the content of drug

advertising. Published regulations require that all drug ads include a “brief

summary” statement that discloses all the drug’s known risks. Because most

commercial advertising is limited in length or duration, drug makers found

compliance with these regulations difficult, particularly in television and radio

advertising. Until 1997, FDA had given no guidance to the drug industry on how

the “brief summary” requirements for broadcast advertising could be met. It then

issued a draft guidance, finalized in 1999, clarifying that it would treat broadcast

advertising differently than print advertising. It stipulated that broadcast ads had to

include the advertised product’s most important risks (called a “major statement” by

FDA) in the audio portion of the advertisement. FDA’s guidance provided that the

DTC ads should give sources where more complete risk information about a drug

would be available (i.e., on Internet sites, toll-free telephone numbers, referral to

health care providers, and large-circulation print sources).

Some Members of Congress are asking whether FDA’s current policies on DTC

ads give consumers information that appropriately balances risks and benefits or

whether ads misrepresent important information patients need prior to purchasing or

consuming the drug. This report examines legislative concerns and options on risk

and health information as they relate to advertising of drugs. It also discusses

activities that could be undertaken with current legislative authority to address

concerns about DTC advertising; and examines options for new statutory authority

on DTC advertising.

This report will be updated periodically.

Contents

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

Growth in Spending on DTC Prescription Drug Advertising . . . . . . . . . . . . . . . . 2

Effectiveness of Spending on DTC Ads . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

R & D Spending Versus Promotional Spending . . . . . . . . . . . . . . . . . . . . . . 4

Impact of DTC Advertising . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Impact on Number of Adverse Events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Impact on Behavior . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Consumer View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Physician View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Industry View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

FDA’s Existing Authority to Regulate DTC Advertising . . . . . . . . . . . . . . . . . . 15

Federal Food, Drug, and Cosmetic Act (FFDCA) . . . . . . . . . . . . . . . . . . . . 15

Regulations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

FDA Use of Current Authority . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Guidance for Broadcast Ads . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Draft Guidance for Print Ads . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Brief Summary Guidance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Disease-Awareness Guidance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

FDA’s Enforcement Activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Funding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Legislative Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Risk and Health Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Activity Under Current Authority . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Pre- and Post-Publication Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

FDA-Mounted Consumer Education . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Increase in FDA-Industry Collaboration . . . . . . . . . . . . . . . . . . . . . . . 28

Increase FDA’s Enforcement Activity . . . . . . . . . . . . . . . . . . . . . . . . . 29

Additional Activity Requiring New Authority . . . . . . . . . . . . . . . . . . . . . . 29

Increase Compliance and Enforcement Tools . . . . . . . . . . . . . . . . . . . 30

Require Pre-Release Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Set Limits on Timing and Placement of Ads . . . . . . . . . . . . . . . . . . . . 30

Ban DTC Advertising . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Previously Proposed Legislation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

List of Tables

Table 1. Total U.S. Promotional Spending on Prescription Drugs, 1996-2003 . . 2

Table 2. Drug Companies’ Spending on R&D, Promotional Activities,

and DTC Advertising . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Table 3. FDA Findings on Patients’ Attitudes and Behaviors Associated

with DTC Promotion of Prescription Drugs . . . . . . . . . . . . . . . . . . . . . . . . . 9

Table 4. FDA Findings in 2002 on Physicians’ Attitudes and Behaviors

Associated with DTC Promotion of Prescription Drugs . . . . . . . . . . . . . . . 12

Table 5. Appropriations for CDER’s Division of Drug Marketing, Advertising,

and Communications FY2003, FY2004 (actual), FY2005 (projected),

and FY2006 (requested) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Table 6. Funding for the CDER’s Office of Drug Safety and Full-Time

Equivalent (FTE) Positions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Direct-to-Consumer Advertising

of Prescription Drugs

Introduction

Direct-to-Consumer (DTC) advertising is usually described as any promotional

effort by pharmaceutical companies to present prescription drug information to the

general public through the lay media.1 DTC advertising shows up in magazines,

newspapers, non-medical journals, pharmacy brochures, and direct-mail letters, and

on television, radio, videos, and Internet websites. Anyone who watches television

or listens to the radio today has likely seen or heard some sort of DTC advertisement

for prescription drugs. The ads usually fall into one of three categories:2

“Product-claim” ads that include a product’s name and a therapeutic

claim about the product.

“Help-seeking” ads that discuss a particular disease or health

condition, and advise the consumer to “see your doctor” but do not

mention the product’s name.

“Reminder” ads that call attention to the product’s name but make

no reference to the health condition the drug is used to treat.

Of these three categories of advertisements, the Food and Drug Administration

(FDA) has the authority to directly regulate only product-claim ads. The regulations

require that therapeutic claims not be false or misleading. The agency regulations

differentiate between print and broadcast DTC product-claim ads. Print ads must

contain all the risk information described in the drug’s FDA-approved label,

including major side effects, contraindications, and precautions. Broadcast

advertisements, however, must directly state only major risk information and must

direct viewers and listeners to other sources from which they can access the complete

risk information.

Help-seeking ads also are directed toward consumers but make no health claims.

Reminder ads also make no health claims but are primarily directed toward doctors

and health care professionals, who are more likely than consumers to know about the

advertised product and its use. They also serve to acquaint consumers with brand

names of products. Although the agency monitors these two types of ads, to ensure

R.G. Frank et al., Prescription Drug Policy Issues in California, report prepared for the

California HealthCare Foundation, Apr. 1999, in Michael S. Wilkes, Robert A. Bell, and

Richard L. Kravitz, “Direct to Consumer Prescription Drug Advertising: Trends, Impact,

and Implications,” Health Affairs, Mar./Apr. 2000. (Hereafter cited as Frank et al.,

Prescription Drug Policy Issues.)

[http://www.fda.gov/cder/handbook/adverdef.htm].

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there is no implication of a product claim, it has issued only draft guidance on them

because it does not have the authority to regulate these ads.

This report focuses on the impact of product claim ads and the regulatory

requirements for these ads. This report also discusses FDA’s funding, enforcement

authority and initiatives, “commercial speech” court rulings, previous legislation, and

other relevant agency activities.

Growth in Spending on DTC

Prescription Drug Advertising

Promotion and prescription drug DTC spending has reached significant levels

in recent years. Table 1 shows annual spending since 1996 on DTC advertising,

along with spending on other types of promotional activities by pharmaceutical

companies.

Table 1. Total U.S. Promotional Spending

on Prescription Drugs, 1996-2003

(millions of dollars)

Type

1996

1997

1998

1999

2000

2001

2002

2003

1,069

1,317

1,848

2,467

2,679

2,638

3,235

Promotion to consumers

DTCa

791

Other industry identified promotional activities

Officeb

2,258

2,785

3,386

3,607

4,038

4,789

5,327

4,455

Hospitalc

552

579

671

713

765

702

873

819

Journal adsd

459

510

498

470

484

425

437

448

Retail value

of samplese

4,904

6,047

6,602

7,230

7,954

10,454

11,909

16,373

Total

9,164

10,991

12,474

13,868

15,708

19,059

21,184

25,330

Source: IMS Health, Integrated Promotional Services TM and CMR, 6/2004

a. DTC promotion represents the expenditures for direct-to-consumer pharmaceutical advertising for

prescription products on television, magazines and newspapers, on radio and outdoors.

b. Office promotion includes costs associated with sales activities of pharmaceutical representatives

that are directed to office-based physicians (often referred to as “detailing.”)

c. Hospital promotion captures the costs associated with sales activities of pharmaceutical

representatives that are directed to hospital-based physicians and directors of pharmacies.

d. Journal advertising reflects advertising expenditures for prescription products appearing in medical

journals.

e. The retail value of the product sampling activities of pharmaceutical representatives are those

directed to office-based physicians, as reported by members of their front office staff.

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According to Table 1, spending on DTC advertising of prescription drugs grew

more than quadrupled between 1996 and 2003, rising from $791 million in 1996 to

$3.2 billion in 2003. In 2003, spending on DTC ads constituted approximately 13%

of all promotional spending for pharmaceuticals; when the retail value of samples is

subtracted from the total amount, DTC advertising made up 36% of promotional

spending, second only to the cost of pharmaceutical representatives’ physicianoffice sales activities (“detailing”).

One critic claims, however, that the drug companies use many different

marketing methods to influence prescribing decisions of physicians, not all of which

are included in the reported promotional spending (as seen in Table 2) of the drug

industry.3 These activities, she asserts, include educational meetings and luncheons

that the industry provides to doctors, hospitals, and medical schools.4

Effectiveness of Spending on DTC Ads

Studies differ in how advertising effectiveness is measured. According to IMS

Health,5 promotional spending has yielded increased sales for at least 49 brand-name

drugs. IMS Health found in its study of “return on investment” in DTC advertising

that at least 90% of the brands demonstrated positive returns; 70% of the brands had

returns in excess of $1.50 for each dollar invested; and 35% were in excess of $2.50.

The best- performing brand yielded a return of $6.50 per dollar invested.6 The study

found that 10 of the leading 12 brands had sales of over $1 billion. For these brands,

return on investment was $3.66 per dollar spent compared with slightly more than

one dollar for every dollar spent on brands with sales below $200 million. Other

research has also found a good return for DTC ads. This research suggests “a yield

of an additional $4.20 in sales for every dollar spent on DTC advertising.”7

Pharmaceutical Research and Manufacturers of America (PhRMA), the trade

association representing the major drug manufacturers, believes that advertising,

Marcia Angell, The Truth About the Drug Companies: How They Deceive Us and What

to Do About It (New York, Random House, 2004).

Ibid. See also comments made by Janet Woodcock, FDA’s Acting Deputy Commissioner

for Operations, that drug companies continue to offer physicians free cruises and stays in

exotic resorts. U.S. Congress, Senate Committee on Health, Education, Labor and Pensions,

Ensuring Drug Safety: Where Do We Go from Here? hearings, 109th Cong., 1st sess., Mar.

3, 2005. Comments discussed in Gardiner Harris, “Drug Makers Are Still Giving Gifts to

Doctors, F.D.A. Official Says,” New York Times, Mar. 4, 2005.

IMS is a for-profit source for pharmaceutical market intelligence, with operations in more

than 100 countries, employing 6,000 professionals, and with an annual revenue of $1.4

billion. See [http://www.imshealth.com].

IMS Management Consulting [David Gascoigne], “DTC at the Crossroads: A ‘Direct’

Hit...or Miss?” IMS Issues and Insights, Sept. 23, 2004, at [http://www.imshealth.com/ims/

portal/front/articleC/0,2777,6599_5266_58193110,00.html].

Meredith B. Rosenthal, Ernst R. Berndt, Julie M. Donohue, Arnold M. Epstein, and

Richard G. Frank, Demand Effects of Recent Changes in Prescription Drug Promotion

(Menlo Park, CA: The Kaiser Family Foundation, June 2003), pp. 18-19.

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particularly DTC advertising, fosters competition among products which could lead

to lower prices for consumers.8 Other researchers observe, however, that it is unclear

how DTC advertising would lead to lower prices because the point of the ads is to

build consumer loyalty to a specific product whatever its price.9 Decisions on how

pharmaceutical manufacturers set prices and whether they pass the costs of DTC

advertising on to consumers are proprietary.

R & D Spending Versus Promotional Spending

The total amount spent on prescription drug advertising has raised a number of

concerns with some Members of Congress. One such concern is that the drug

industry could be spending more on marketing and promotion than on research and

development, which some see as unacceptable. The drug industry association

disputes that assertion, reporting that R&D spending exceeded promotional spending

every year for the last five years (See Table 2).

Table 2. Drug Companies’ Spending on R&D, Promotional

Activities, and DTC Advertising

(billions of dollars)

Type

1999

2000

2001

2002

2003

Research and development

22.7

26.0

29.8

31.0

33.2

Promotional spending

13.9

15.7

19.1

21.2

25.3

Direct-to-Consumer advertising

1.8

2.5

2.7

2.6

3.2

DTC advertising as a % of R&D spending

10%

Source: PhRMA, Pharmaceutical Marketing and Promotion, Tough Questions, Straight Answers,

Nov. 2004, [http://www.phrma.org/publications/policy/2004-11-10.1095.pdf].

Impact of DTC Advertising

Federal agencies, consumers, physicians, health care organizations, and industry

groups hold a variety of opinions on the effect of DTC advertising. Hearings in the

fall of 2004 raised questions about the role of DTC advertising in evaluating drug

safety. In November 2004, FDA finalized analysis of three surveys of patients and

physicians (a patient survey in 1999, and two surveys in 2002, one with patients and

the other with physicians). Survey results are discussed below and are summarized

in Tables 3 and 4. FDA found that DTC advertising affects information seeking,

Testimony of Gregory J. Glover, representing the Pharmaceutical Research and

Manufacturers of America before the U.S. Congress, Senate Committee on Commerce,

Science, and Transportation, Subcommittee on Consumer Affairs, Foreign Commerce, and

Tourism, Prescription Drug Issues, hearings, 107th Cong., 1st sess., July 24, 2001.

(Hereafter cited as Glover, Senate Commerce Committee Testimony, 2001.)

Frank et al., Prescription Drug Policy Issues, p. 110.

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healthcare visits, questions and/or requests of physicians and ultimately the public

health.

Most DTC advertising targets individuals with chronic health conditions, such

as allergies, stomach ulcers, depression, high blood pressure, and high cholesterol.

Some advertisements target caregivers and family members of those with chronic

conditions, or those who may be at risk of a given disease.10 Ads for osteoporosis

medications, for example, are said to be targeted towards women in their 40s and 50s

who may have some genetic predisposition for the disease. Such ads attempt to

educate patients about different health conditions, and attempt to create a demand for

the drug, in part by increasing interaction between patients and their doctors.

The criteria and discussions leading to company decisions on which medications

to advertise are proprietary. Most of the top selling brand-name products are

extensively advertised, and the advertising increases public awareness of these

drugs.11

Impact on Number of Adverse Events

Recent events have brought FDA’s policies on DTC advertisements into focus

for Congress.12 Some Members have expressed concern about post market problems

with the safety of certain drugs and the potential of causing harm to consumers. The

perceived connection with DTC is that drug companies often use DTC ads to

promote newly approved medications. Although judged safe by FDA with evidence

from clinical trials, these approved drugs had been tested only on a certain number

of patients (5,000 or fewer) and compared almost always with a placebo. With large

Ed Slaughter, Corporate Director, Advertising and Trends Research, Rodale, Inc.,

“Seventh Annual Survey: Consumer Reaction to DTC Advertising of Prescription

Medicines,” Prevention Magazine, 2004, pp. 1-7.

Ibid.

Hearings in the fall of 2004 looked at whether certain antidepressants heighten suicidal

thoughts and behaviors among children. U.S. Congress, House of Representatives,

Committee on Energy and Commerce, Subcommittee on Oversight and Investigations,

FDA’s Role in Protecting the Public Health: Examining FDA’s Review of Safety and

Efficacy Concerns in Antidepressant Use by Children, hearings, 108th Cong., 2nd sess., Sept.

9, 2004. In September 2004, Merck & Co. withdrew its anti-inflammatory medication

Vioxx from the market because studies had shown an elevated heart-attack and stroke risk

with prolonged use. Questions were raised at a November 2004 Senate Finance Committee

hearing about whether earlier studies by the company and others had suggested this risk in

Vioxx. See U.S. Congress, Senate Committee on Finance, FDA, Merck and Vioxx: Putting

Patient Safety First? hearing, 108th Cong., 2nd sess., Nov. 18, 2004. At an FDA advisory

panel meeting, February 16-18, 2005, the members voted for continuing marketing of Vioxx,

Celebrex and Bextra but with stern warnings on the labels of these drugs, severely limited

DTC advertising, and requirements that drug makers provide patients with information

outlining the drugs’ risks. FDA has pledged to consider the advisory panel

recommendations in any regulatory actions the agency may take. However, some groups,

notably Public Citizen, are arguing that all COX-2 drugs (class of drugs to which Vioxx,

Celebrex and Bextra belong) should be removed from the market.

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DTC advertising campaigns, many thousands and sometimes millions of people

begin to take the drug.

With this large-scale use, a drug with serious side effects and risks that went

undetected in pre-market trials may cause injury before the problem is recognized.

FDA’s adverse event reporting system, MedWatch, is intended to identify problems

encountered as drugs are used in the wider population and to report this information

back to physicians and medical care personnel. It is, however, a passive surveillance

system, gathering anecdotal and often incomplete information from physicians and

consumers.13 Some in Congress, therefore, are wondering whether the MedWatch

system is doing its job as well as it might. In addition some question whether the

system for dispersing information on problems is reaching the medical professions

in a timely manner.14

Others are concerned that DTC ads minimize the risks of certain medications

while promoting the benefits. Critics say that some patients, taking these DTC

heavily promoted drugs, could use other medications with fewer side effects for

which there are more established health track records.15 But drug industry

representatives claim that prior to FDA’s approval the drugs have been studied and

proven safe with clinical trials and that they are safe under the labeled conditions of

use.

On December 17, 2004, FDA asked Pfizer, Inc. to voluntarily suspend DTC

advertising on Celebrex (one of a class of anti-inflammatory drugs potentially linked

to heart disease) while the agency obtains and evaluates new and conflicting

scientific data on adverse events associated with the drug.16 Pfizer agreed to stop its

advertising. FDA also requested that the company change the information provided

to physicians to reflect the recommendations FDA made encouraging physicians to

consider alternative therapies as they evaluate their individual patients’ needs.

Because the MedWatch system provides a count of events without giving the total number

of users, it is difficult to obtain systematic assessments of experience with prescription drugs

following trials and FDA approval.

CRS Report RL32797, Drug Safety and Effectiveness: Issues and Action Options After

FDA Approval, by Susan Thaul.

“[O]verall harm from a new pharmaceutical may be increased when rapid expansion of

prescribing occurs prior to the development of definitive data on safety. With new drugs

whose safety profile is not well characterized, greater regulatory efforts to limit the use of

the drug to the clinical population in which an unambiguous outcome benefit exists may

minimize the potential for overall public harm,” Carolanne Dai, Randall S. Stafford, and G.

Caleb Alexander, “National Trends in Cyclooxygenase-2 Inhibitor Use Since Market

Release: Nonselective Diffusion of a Selectively Cost-effective Innovation,” Archives of

Internal Medicine, vol. 165 (2005), pp. 171-177, at [http://archinte.ama-assn.org/current.dtl].

“[T]he impact of marketing and promotional efforts must also be considered. COX-2

inhibitors have been heavily promoted both through direct-to-consumer advertising as well

as to physicians.” Ibid. See also Food and Drug Administration, “FDA Statement on

Celebrex DTC Promotion,” Dec. 20, 2004, at [http://www.fda.gov/bbs/topics/news/

2004/new01147.html].

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Impact on Behavior

Two government agencies have stated that competition gives drug companies

an incentive to deliver truthful and accurate information to consumers. Their studies

confirm that DTC advertising is a powerful tool communicating health and wellness

information to consumers that can change people’s behavior. They claim, “good

information is a necessary building block for both consumer empowerment and

enhanced health.”17 However, one critic claims that it is impossible to separate what

is the educational component of an advertisement from the marketing component

because it is all marketing.18 The title of a New England Journal of Medicine

perspectives piece — “To Inform or Persuade?” — describes the dilemma.19

Consumer View. FDA conducted two national patient telephone surveys (one

in 1999 and the other in 2002) to find out what patients thought of DTC advertising.20

The results are summarized in Table 3. Most patients (81%) were aware of ads and

that the ads contained both benefit and risk information. The ads prompted 43% of

respondents to look for more information about a drug or medical condition. Almost

89% sought the information from their physicians, about 51% from their pharmacists,

about 40% from reference books and 38% from friends, relatives, and neighbors.

The survey indicated that fewer people in 2002 (18%) asked their physician about

previously untreated conditions than in 1999 (27%). In the 2002 survey, fewer

consumers held positive views of DTC ads than they had in 1999.

The results of FDA’s surveys showed that the proliferation of DTC advertising

has led many patients to become aware of newly available medical treatments for

certain health conditions, and that patients are motivated to ask better questions of

the healthcare provider. Some pharmaceutical companies call their messages

“educational” and claim that DTC ads encourage patients to seek medical advice for

conditions that sometimes go untreated.21 For example, urinary incontinence and

erectile dysfunction advertising brought these two apparently under-diagnosed and

under-treated conditions to consumer attention. As such, these ads can lead to better

The Federal Trade Commission regulates the advertising of all consumer products other

than prescription drugs. U.S. Department of Justice and the Federal Trade Commission,

Improving Health Care: A Dose of Competition, July 2004, p. 20, at [http://www.usdoj.gov/

atr/public/health_care/204694.htm].

Marcia Angell, The Truth About the Drug Companies: How They Deceive Us and What

to Do About It (New York, Random House, 2004).

Ernst R. Berndt, “To Inform or Persuade? Direct-to-Consumer Advertising of

Prescription Drugs,” New England Journal of Medicine, vol. 352, no. 4 (Jan. 27, 2005), pp.

325-328.

For the 1999 survey, the response rate out of 960 patients was 65%. For the 2002 survey,

the response rate for 944 people was 53%.

IMS Management Consulting [David Gascoigne], “DTC at the Crossroads: A ‘Direct’

Hit...or Miss?” IMS Issues and Insights, Sept. 23, 2004, p. 2.

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patient-physician discussions, leading to, for example, life-style changes that could

be beneficial to their health (e.g., losing weight), independent of new drug use.22

The patient survey data provided limited evidence of increased visits to

physicians as a result of DTC advertising.23 Most people reported that health reasons

prompted their visits to physicians. DTC ads can improve patient compliance with

physician advice, the surveys found, particularly if physicians remind patients to take

the medication as prescribed. These ads also have spurred patients to seek

information about a given disease from sources other than their physicians.

FDA’s patient surveys also showed patients had some negative reactions to DTC

advertising. Patients felt that the ads can overstate drug efficacy and do not present

a balance of benefit and risk information. Patients gave only modest ratings to the

information that was meant to provide a more complete picture of the drug product’s

risk. In the 2002 survey versus the 1999 survey, fewer found DTC ads useful in

conversations with their physicians and with healthcare decision making.

However, some ads also may encourage consumers to believe a common health

problem can easily be fixed by a prescription drug. In fact, FDA’s Center for Drug

Evaluation and Research (CDER) Director has discussed what she calls the

“medicalizing of health” by saying that some believe, due to DTC advertising, that

“all aches should be treated with some pill.”24 The concern is that some people who

have managed a small health problem with over-the-counter medications, for

instance, are now pressing physicians to provide prescription drugs. The process may

expose some people to harmful side effects of drugs that may not necessarily be

needed. Other findings are summarized in Table 3.

Wendy Borow, “The AMA Explains Its About-face on Direct-to-Consumer Advertising,”

Medical and Marketing & Media, Sept. 1993, p. 68-74.

Kathryn J. Aikin, John L. Swasy, and Amie C. Braman, “Patient and Physician Attitudes

and Behaviors Associated with DTC Promotion of Prescription Drugs: Summary of FDA

Survey Research Results,” Final Report, U.S. Department of Health and Human Services,

Food and Drug Administration, Center for Drug Evaluation and Research, Nov. 19, 2004.

Comments made by Janet Woodcock, Director of the Center for Drug Evaluation and

Research, at a public meeting titled “Research on Consumer Directed Advertising,” given

by the U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Sept.

22-23, 2003.

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Table 3. FDA Findings on Patients’ Attitudes and Behaviors

Associated with DTC Promotion of Prescription Drugs

Category of information

1999 survey results a

2002 survey results

Visits to healthcare provider

Not asked.

Generation of questions

About 33% of patients said DTC had generated questions for their physician;

33% said friends and family generated questions; and 20% reported reference

books sparked questions.

Expectations about

receiving Rx

42% of patients expected a prescription at the most recent doctor’s visit; of

these, 63% expected a refill, 17% were sick, and 6% had seen a television ad and

5% had seen a magazine ad that kindled the expectation.

Asking behaviors

4% of patients surveyed who had visited

their doctor had done so because of an ad.

32% of patients asked if any drug were available. Of these, 39% asked about a

specific brand. Over 90% reported that their physicians welcomed questions.

Prescribing response

50% of patients reported getting a prescription for drug asked about. 33% got

a different drug and 41% were told to change behavior or diet. Patients who

asked for a specific named drug were more likely to get a prescription for that

drug than patients who did not ask about a specific drug.

Patient opinions about DTC

advertising

86% of patients agree that ads

increase awareness of new

drugs; 70% felt ads provide

enough information to discuss

with physician; 60% say ads do

not provide enough risk

information and 44% say ads

lack benefit information.

77% of patients agree that ads increase

awareness of new drugs; 58% felt ads provide

enough information to decide whether to

discuss with physician; 39% thought ads

encourage patients to seek more information

about potentially serious medical conditions.

As in 1999, 60% say ads do not provide

enough risk information and 44% say ads

lack adequate benefit information.

Influence on relationship

with healthcare provider

62% of patients felt ads led to

better discussions with doctor;

7% of patients were reluctant to

discuss advertised drug for fear

of implying mistrust of doctor.

73% of patients agreed that ads do not

minimize physicians’ role in product

decisions; 43% said ads helped in discussions

with physicians; 10% of patients were

reluctant to discuss advertised drug for fear of

implying mistrust of the physician.

Overstatement of benefits

Not asked.

58% of patients said ads portray products as

better than they are; 42% felt ads make it

seem that the product would work for

everyone.

Effects on own health

47% of patients felt ads help

them make better health

decisions. No other questions

were asked.

32% of patients felt ads help them make

better health decisions; 18% said ads

reminded them to take medicines; 17% said

ads caused anxiety about health.

General attitudes

52% of patients reported they

liked seeing DTC ads.

32% of patients reported they liked seeing

DTC ads.

Understanding the Brief

Summary risk information

Not asked.

78% of those interested read all or most of

the main ad; 45% of patients read most or all

of the risk details in the Brief Summary when

interested in the drug; 50% of those who read

some of the Brief Summary said it was

difficult to read.

Cost issues

40% of patient respondents never discuss the cost of drugs with their doctors;

16% discuss it frequently. Most likely to discuss cost with their physicians were

female patients in poor health taking prescription drugs and lacking drug

insurance.

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Source: Kathryn J. Aikin, John L. Swasy, and Amie C. Braman, “Patient and Physician Attitudes and

Behaviors Associated with DTC Promotion of Prescription Drugs: Summary of FDA Survey Research

Results,” Final Report, U.S. Department of Health and Human Services, Food and Drug

Administration, Center for Drug Evaluation and Research, Nov. 19, 2004.

a. Where percentages stayed relatively the same in both the 1999 and 2002 surveys, results are

presented as one.

Several other surveys added other perspectives to the issue. For example, a

survey by the magazine Prevention found that even with the pervasiveness of DTC

advertising in magazines and on television and with the tremendous increase in

spending on DTC ads, patients’ requests of their physicians for or about advertised

drugs has remained stable at about 8%. The author concludes that the ads “can’t

overcome Americans’ desire to avoid taking prescription drugs.”25 However, this

survey also showed that about 7% of people surveyed asked for and received a

prescription drug because of DTC advertising and 7% stopped taking a drug after

seeing it advertised. It also established that a positive public health response to the

advertising was that patients seek information about health conditions for themselves

or for people in their care. This same survey states that “consumers are three times

more likely to search for information about medicines family members or friends are

already taking, than they are to ask their doctors for medicines for themselves.”26

Another study conducted by several Harvard professors found a portion of

patients visits that were spurred by DTC ads were for clinically important conditions

that resulted in a new diagnosis.27 Their study did not detect widespread adverse

effects of DTC ads on people’s health. This study also found that consumers can

gain extra benefits not limited to the advertised drug because they get supplementary

information about their health.

Physician View. Some physicians believe that DTC advertising serves as an

effective tool for providing health information to consumers. Some believe that DTC

advertising is one reason patients are visiting their doctors more, undergoing tests to

catch health problems earlier, taking their medicines regularly, and getting more

involved in their own treatment. However, some physicians mistrust DTC

advertising because, in their opinion, the ads often promote a view of medicine that

is misleading. Some say that the information presented in DTC ads obscures

information about a drug’s risks.28 Less expensive drugs can often work as well as

Ed Slaughter, Corporate Director, Advertising and Trends Research, Rodale, Inc.,

“Seventh Annual Survey: Consumer Reaction to DTC Advertising of Prescription

Medicines,” Prevention Magazine, 2004, p. 7.

Ibid., p. 60.

Joel S. Weissman, David Blumenthal, Alvin J. Silk, Kinga Zapert, Michael Newman, and

Robert Leitman, “Consumers’ Reports on the Health Effects of Direct-to-Consumer Drug

Advertising,” Health Affairs — Web Exclusive, Feb. 26, 2003, p. W3-82 to W3-95.

Council on Ethical and Judicial Affairs of the American Medical Association, “Direct-toConsumer Advertisements of Prescription Drugs,” Food and Drug Law Journal, vol. 55,

2000, p. 121.

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the advertised drugs,29 and some claim that DTC advertising can give the false

impression to consumers that prescription drugs are just like any other commercial

product — soap, cars, cereal, snacks — and that patients only need a specific pill to

fix whatever ails them.30 This attitude, some say, could contribute to an

unwillingness on the part of the patient to make needed lifestyle changes. DTC ads

rarely, if ever, discuss non-drug forms of treatment.

In 2002, FDA questioned office-based physicians about the role of DTC in

influencing their practices and relationships with their patients. Table 4 summarizes

the agency’s presentation of the survey’s findings. Out of a sample of 250 primary

care physicians and 250 specialists chosen randomly from the American Medical

Association (AMA) master file, 46% responded. Physicians, particularly primary

care physicians, noted an increase in questions about prescription drug treatments

with 85% saying patients asked often or all the time, and 62% reported patients asked

frequently about generic drugs. They also described benefits and problems that

arose. Most physicians reported being comfortable with denying medications

particularly when the requested drug is not right for the patient. Ninety-three percent

of physicians welcomed questions about specific drugs from patients, and between

74% and 77% of the doctors prescribed the requested drug when a specific drug was

requested.31

National Institute for Health Care Management (NIHCM) Foundation. Factors Affecting

the Growth of Prescription Drug Expenditures. Prepared by Barents Group LLC, July 9,

1999, p. 14.

Ibid., p. 7.

Kathryn J. Aikin, John L. Swasy, and Amie C. Braman, “Patient and Physician Attitudes

and Behaviors Associated with DTC Promotion of Prescription Drugs: Summary of FDA

Survey Research Results,” Final Report, U.S. Department of Health and Human Services,

Food and Drug Administration, Center for Drug Evaluation and Research, Nov. 19, 2004.

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Table 4. FDA Findings in 2002 on Physicians’ Attitudes and

Behaviors Associated with DTC Promotion of Prescription

Drugs

Category of information

2002 survey responses

Benefits and problems of patient

DTC exposure

41% of physicians thought exposure was beneficial, leading

to better discussions, greater awareness of treatments, and that

DTC was a source for informing patients. 18% said exposure

led to problems such as misconceptions, requiring physician

correction, requests for unnecessary drugs, and requests for

one medication when another treatment was effective. 73%

said patients asked thoughtful questions because of DTC

exposure. 41% of physicians said patients were confused

about drugs effectiveness because of the DTC ad.

Patient drug requesting behavior

The survey distinguished between patients asking if there

were a drug to treat a specific problem and those asking for a

specific drug. 86% of physicians recalled patients asking

about a drug and 88% of them said that the patient had the

condition the drug treats. 77% of primary care physicians

prescribed the requested drug whereas 74% of specialists did.

Denial of requests

Most frequent reason given by physicians for denial was that

the drug was not right for the patient and another drug was

more appropriate.

Primary care physicians denied

prescriptions for a variety of reasons: because there was a less

expensive drug available, no prescription was required, or

patient could engage in behavioral or diet changes.

Specialists declined prescriptions because a different drug was

appropriate, a drug was not right for patient, or the drug had

side effects unknown to the patient.

Pressure to prescribe

50% of physicians reported no pressure, and 91% reported a

patient did not try to influence treatment that would have been

harmful to patient. 22% of primary care physicians felt

“somewhat” or “very pressured” to prescribe; 13% of

specialists felt that way. 73% of primary care physicians

reported patients came to the appointment expecting a

prescription versus 63% of specialists. Primary care

physicians were more likely to say this influenced their

prescribing.

General opinions about patient

understanding of DTC advertising

Physicians thought that 75% of patients understood that drugs

are available only with a prescription, 82% knew that only a

physician could make the decision about appropriateness, and

78% understood the drug’s benefits. Between 40%-50%

believed patients understood the risks and possible negative

effects of drugs, 30% understood the limits of drug efficacy,

and 25% were the type of person who should avoid drugs.

Opinions about problems

65% of physicians felt patients confuse the relative risks and

benefits of DTC advertised drugs and 75% felt that ads led

patients to overestimate the efficacy of the drugs. 38%

believed DTC ads caused patients to question their diagnoses,

and 28% said that ads led to tension in the doctor-patient

relationship.

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Category of information

2002 survey responses

Opinions about benefits

72% of the physicians think DTC ads increase awareness of

possible treatments, 44% believe that ads facilitate earlier

awareness of health conditions. About 33% think DTC ads

increase the likelihood of proper medication usage, and 33%

believe ads help patients maintain treatment.

Overall impressions of influence

of DTC advertising on patients

and practice

33% of physicians said that DTC ads had positive effect; 33%

said ads had a negative effect; and 33% said the ads had no

effect at all. 38% of primary care and 27% of specialists rated

DTC advertising as having a somewhat or very negative effect

on their patients and practice.

Source: Kathryn J. Aikin, John L. Swasy, and Amie C. Braman, “Patient and Physician Attitudes and

Behaviors Associated with DTC Promotion of Prescription Drugs: Summary of FDA Survey

Reseearch Results,” Final Report, U.S. Department of Health and Human Services, Food and Drug

Administration, Center for Drug Evaluation and Research, Nov. 19, 2004.

Industry View. Drug companies rely on DTC advertising to stimulate demand

and to increase sales for pharmaceuticals.32 The drug industry claims that DTC ads

have increased consumer awareness that all prescription drugs have risks and side

effects; that non-drug approaches exist to improve health; and that advertisements

remind and motivate consumers to comply better with drug therapy regimes.33

According to the pharmaceutical industry, the increase in prescription drug use and

spending appears to be the result of several different factors, and not necessarily

attributable to DTC advertising: a significantly greater number of prescriptions being

written for an aging population to restore and/or maintain health; a shift in

prescriptions to newer higher cost drugs; new standards of medical practice

encouraging greater use of drugs; more treatment of previously untreated patients;

and a greater attention to preventing and managing disease resulting in net savings

at times compared with spending in hospitals.34 In addition, if more people take a

specific drug or the same number of people are using the drug but more frequently

(staying compliant), the total amount of what is spent on the drug will also increase.35

As discussed earlier, economists have stated that recent growth in DTC

advertising has increased the demand for well-publicized drugs because, as people

learn of alternative therapies, consumers may request newer, higher-priced drugs in

Glover, Senate Commerce Committee Testimony, 2001, p. 5.

Testimony of Senior Assistant General Counsel Marjorie E. Powell, Pharmaceutical

Research and Manufacturers of America before the U.S. Congress, Senate Special

Committee on Aging, Direct to Consumer Advertising: What are the Consequences?,

hearings, 108th Cong., 1st sess., July 22, 2003.

Ibid., pp. 11-12.

Geoffrey F. Joyce, Jose J. Escarce, Matthew D. Solomon, and Dana P. Goldman,

“Employer Drug Benefit Plans and Spending on Prescription Drugs,” JAMA, vol. 288, no.

14 (Oct. 9, 2002), pp. 1733-1739. Increasing co-payments for prescription drugs and

requiring mandatory generic substitution reduced overall drug spending among working age

enrollees with employer-provided drug coverage.

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place of less expensive ones, thereby increasing health care costs.36 Whether that

substitution is medically necessary is another issue. However, one physician

testifying before the Senate Special Committee on Aging concluded that DTC

advertising can drive the spending on pharmaceuticals but is responsible for only a

small share of the total growth in spending on drugs, referring instead to other factors

mentioned above.37

Studies sponsored by both industry and academic researchers suggest that the

ads can lead to cost-effective treatments in some circumstances.38 For example,

many experts find that although “statin” drugs lower blood cholesterol levels and are

relatively cost-effective as secondary prevention in persons with existing heart

disease, they are much less cost-effective than primary prevention such as weight

control and exercise.39

A spokesman for the pharmaceutical industry in testimony before Congress

stated that medicines are the “most cost effective form of health care” because they

can keep patients out of hospitals and nursing homes and avoid surgery.40 He quoted

a National Institutes of Health study which found that clot-busting drugs used to treat

stroke patients save, on average, $4,300 a year per patient by reducing the need for

hospitalization, rehabilitation, and nursing-home care.41 However, others, who have

researched cost-effectiveness of pharmaceuticals, say that the question of whether

drugs are cost effective “depends critically on the context in which the drug is used

and the intervention to which it is being compared.”42

Stephen Heffler, Katherine Levit, Sheila Smith, Cynthia Smith, Cathy Cowan, Helen

Lazenby, and Mark Freeland, “Health Spending Growth Up in 1999; Faster Growth

Expected in the Future,” Health Affairs, vol. 20, no. 2 (Mar./Apr. 2001), p. 198.

Testimony of Meredith B. Rosenthal in U.S. Congress, Senate Special Committee on

Aging, Direct to Consumer Advertising: What are the Consequences? hearing, 108th Cong.,

1st sess., July 22, 2003.

Frank Lichtenberg, Benefits and Costs of Newer Drugs: An Update, Working Paper 8996.

National Bureau of Economic Research, June 2002 at [http://www.nber.org/papers/w8996].

Peter J. Neumann, Eileen A. Sandberg, Chaim M. Bell, Patricia W. Stone, and Richard

H. Chapman, “Are Pharmaceuticals Cost-Effective? A Review of the Evidence,” Health

Affairs, vol. 19, no. 2 (Mar./Apr. 2000), pp. 97 and 99 (Hereafter cited as Neumann et al.,

“Are Pharmaceuticals Cost-Effective?”) Cited examples of successful interventions that

produce health benefits for relatively little cost or save money for the health care system are:

warfarin therapy to prevent stroke in patients with atrial fibrillation, immunosuppressive

drugs for those with kidney transplants, and treatment with mood-altering drugs for some

people with depression.

Glover, Senate Commerce Committee Testimony, 2001

S.C. Fagan, L.B. Morgenstern, A. Petitta, R.E.Ward, B.C. Tilley, J.R. Marler, S.R.

Levine, J.P. Broderick, T.G. Kwiatkowski, M. Frankel, T.G. Brott, M.D. Walker, and the

NINDS rt-PA Stroke Study Group, “Cost-Effectiveness of Tissue Plasminogen Activator for

Acute Ischemic Stroke,” Neurology, vol. 50 (Apr. 1998), pp. 883-890.

Neumann et al., “Are Pharmaceuticals Cost-Effective?” p. 104.

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Other critics claim that there is no scientific evidence that DTC ads educate the

public about illnesses or new medicines, or that they encourage physician visits.

Rather, some observers, such as Arnold S. Relman, emeritus editor-in-chief of the

New England Journal of Medicine, say that those assertions are made by salespeople

whose sales have increased due to these ads.43 One research group has looked at how

consumers and physicians report DTC advertising’s effect. It reported that patient

visits to physicians promoted by DTC ads did not necessarily result in a prescription

for the advertised drug.44 The authors commented that consumers benefit when they

visit physicians about a particular drug because many visits resulted in new diagnoses

such as “high cholesterol, hypertension, diabetes, and depression, health conditions

often underdiagnosed and undertreated in the general population.”45 The authors

note, however, as did Dr. Relman in testimony before the Senate Special Committee

on Aging, that these interview studies were not designed to determine whether ads

were misleading, caused patients to receive more expensive drugs than necessary, or

increased the cost of health care. Neither could these studies determine whether

other sources of public information could achieve the educational benefits of DTC

at lower cost.

FDA’s Existing Authority to Regulate

DTC Advertising

The following sections describe the statutory basis for current regulation of DTC

advertisements, recent FDA actions and funding.

Federal Food, Drug, and Cosmetic Act (FFDCA)

The FFDCA sets forth the statutory requirements that pharmaceuticals must

meet before they can be approved for marketing in the United States. Since 1938,

Section 201 of the Act gives the FDA broad authority to consider drugs misbranded

if their labeling or advertising is false or misleading in any way. At the time,

advertising was primarily printed material directed towards physicians. In 1962,

Congress added Section 502(n) to the Act, to give the FDA the authority to regulate

prescription drug promotional labeling and advertising, including DTC

advertisements.46 In the same section, Congress prohibited FDA from issuing any

regulations that would require prior approval of the content of any advertisement.

Testimony of Arnold S. Relman, in U.S. Congress, Senate Special Committee on Aging,

Direct to Consumer Advertising: What Are the Consequences? hearing, 108th Cong., 1st

sess., July 22, 2003.

Joel S. Weissman, David Blumenthal, Alvin J. Silk, Michael Newman, Kinga Zapert,

Robert Leitman, and Sandra Feibelmann, “Physicians Report on Patient Encounters

Involving Direct-to-Consumer Advertising,” Health Affairs — Web Exclusive, Apr. 28,

2004, p. W4-226.

Joel S. Weissman, David Blumenthal, Alvin J. Silk, Kinga Zapert, Michael Newman, and

Robert Leitman, “Consumers’ Reports on the Health Effects of Direct-to-Consumer Drug

Advertising,” Health Affairs — Web Exclusive, Feb. 26, 2003, pp. W3-82 to W3-95.

21 U.S.C. § 502 (n).

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Regulations

In 1969, FDA issued final

Differences between labeling and advertising

regulations governing drug

advertising at 21 C.F.R.

FDA considers promotional material and

Under these

§ 202.1.47

advertising to be different from approved product

regulations, advertisements must

labeling. FDA must approve the wording of a

have four basic attributes: (1)

drug’s approved product labeling before the

they cannot be false or

product can be marketed. Labeling generally

misleading; (2) they must

includes the drug’s known significant side effects

present a “fair balance” of

(both those serious and those not serious but

frequently occurring). It uses technical language

information about the risks and

since the information it conveys is mostly targeted

benefits of using the drug; (3)

at health care professionals. While FDA does have

they must contain “facts” that

authority for approving labeling, it does not, as

are “material” to the product’s

noted, have authority to require the pre-approval

advertised uses; and (4) in

of any promotional materials or advertising,

general, the advertisement’s

including DTC advertising.

“brief summary” of the drug

must include every risk from the

product’s approved labeling. The regulations require that companies submit

promotional materials to FDA at the same time they make them available to the

public.48 The promotion within these materials must be supported by scientific

evidence and be consistent with FDA-approved product labeling. The ads can be the

approved labeling or other promotional materials, but must not recommend or

suggest any use of a drug that is not listed in the approved drug’s labeling. (See text

box.) Only uses approved by FDA can be listed on the label or in advertising.

FDA Use of Current Authority

Monitoring compliance and enforcement of DTC advertising regulations is the

responsibility of FDA’s Division of Drug Marketing, Advertising, and

Communications (DDMAC), a division within the Center for Drug Evaluation and

Research. Most drug manufacturers voluntarily submit draft materials to FDA for

review and comment prior to some of their ads being aired on TV and radio.49 In

fact, some drug manufacturers ask for comments at all stages of their broadcast ad’s

preparation. The agency pays particular attention to final broadcast videotapes

Jane E. Henney, “Challenges in Regulating Direct-to-Consumer Advertising,”MSJAMA

Report, vol. 284 (Nov. 1, 2000), p. 2242.

21 C.F.R. § 314.81(b)(3)(i)states: “The applicant shall submit specimens of mailing

pieces and any other labeling at the time of initial dissemination of the labeling and at the

time of initial publication of the advertisement for a prescription drug product.”

See 21 C.F.R. § 314.81(b)(3)(i). According to an FDA official, pharmaceutical companies

often voluntarily ask for agency comments on their proposed ads to ensure that, prior to

airing, the ads will meet FDA’s requirements, because of the expense of these ads. If it

needs to, the agency can take enforcement actions but only after an ad is made public.

CRS-17

because these ads can make or imply inappropriate claims just by their non-verbal

and visual presentations.

Guidance for Broadcast Ads

With respect to TV and radio ads, until 1997, it was unclear how to comply with

the law for, if a product-claim print advertisement mentioned the name of the

prescription drug and its intended medical indications, it had to include all the

information about side effects, contraindications, and precautions from the product’s

approved labeling.50 For the most part, conveying all of a product’s risk information

in print advertising is not difficult. However, because commercial broadcast

advertisements are often of limited length (30 to 60 seconds), to include this kind of

detailed information in television and/or radio advertising was thought by the drug

industry to be too cumbersome and expensive.51 Although the regulations allowed

for an alternative to presenting every risk in a broadcast advertisement, prior to 1997,

FDA had not issued any interpretation of how broadcast advertisements could fulfill

the “adequate provision” regulation which is an alternative to presenting all the risk

information in the brief summary.52 The industry reportedly assumed that FDA

expected broadcast DTC advertising to meet the same requirements as ads in print.53

In August 1997, FDA issued draft guidance on how pharmaceutical companies

fulfill the existing regulatory requirements for advertising prescription drugs on radio

and television. The draft guidance was finalized, without major change, in August

1999.54 The guidance provided that DTC broadcast advertisements had to include

the advertised product’s most important risks (called a “major statement” by FDA).

The major statement was required to be in the audio portion of the advertisement, but

could be in the video portion as well. The agency explained that the regulations had

always allowed for broadcast advertisements to either include all the drug’s risks or

ensure that consumers would have “adequate provision” of an advertised product’s

approved labeling. The guidance provides one way to ensure that consumers with

different information-seeking needs and capabilities have adequate access to the

product labeling by disclosing four different sources of this information. These

sources,55 which were to be broadly disseminated to the general public, must include:

See [http://www.fda.gov/cder/guidance/index.htm].

Pharmaceutical Research and Manufacturers Association, Direct-to-Consumer

Advertising: Backgrounders and Facts (2000).

21 C.F.R. § 202.1(e)1.

Wayne L. Pines, “A History and Perspective on Direct-to-Consumer Promotion,” Food

and Drug Law Journal, vol. 54, no. 4 (1999), pp. 489-518.

The only significant change in the final guidance was the clarification of FDA’s thinking

that its guidance on broadcast DTC advertising could also be used for telephone

advertisements. 64 Federal Register 43197 (Aug. 9, 1999), at [http://www.fda.gov/cder/

guidance/1804fnl.pdf].

FDA, Center for Drug Evaluation and Research, Intra-Agency Group on Advertising and

Promotion. Questions and Answers on the Consumer-Directed Broadcast Advertisements

Guidance, June 8, 2000, [http://www.fda.gov/cder/guidance/1804q&a.htm].

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Internet sites,56 toll-free telephone numbers, referral to health care providers, and

other print sources with large circulations.57

Draft Guidance for Print Ads

In January 2004, FDA issued three draft guidances: Brief Summary: Disclosing

Risk Information in Consumer-Directed Print Advertisements (brief summary

guidance),”Help-Seeking” and Other Disease Awareness Communications by or on

Behalf of Drug and Device Firms (disease awareness guidance), and a third on

medical device advertising (which will not be discussed here).58 All the guidances

attempt to improve the information that consumers and health care practitioners

receive in advertising about prescription drugs and devices. They also require drug

and medical device firms to disseminate truthful, non-misleading, scientifically

accurate information on medical products and health conditions to consumers and

health care practitioners.

Brief Summary Guidance. FDA requires that any prescription drug

advertisement contain “information in brief summary relating to the side effects,

contraindications, and effectiveness” of the drug.59 The information on the risks of

the product (known as the brief summary) must disclose all the risk-related

information in the drug’s package labeling. So ads in print often include the entire

section of the approved professional labeling with its side-effects and warnings.

FDA has been concerned that the technical language and volume of material

presented discourage consumers from using the information. The agency has now

proposed in its 2004 draft guidance60 that manufacturers choose among three options

(other than printing the entire professional labeling) to satisfy the brief summary

requirement for DTC print ads. All would require that the manufacturer print all

contraindications; all warnings; the major precautions, including any that describe

serious adverse drug experiences or steps to be taken to avoid such experiences; and

the three to five most common nonserious adverse reactions most likely to affect the

patient’s quality of life or compliance with drug therapy.61 What would vary is how

the manufacturer could present that information. The first option would be to reprint

Alex Frangos, Special Report: E-Commerce; Prescription for Change, Wall Street Journal,

Apr. 23, 2001. Web-based sites, whether third-party or proprietary, usually contain a link

to a site that advertises one company’s product. Experts suggest that the line between

information and promotion has been blurred.

64 Federal Register 43197 (Aug. 9, 1999); see also Council on Ethical and Judicial

Affairs of the American Medical Association, “Direct-to-Consumer Advertisements of

Prescription Drugs,” Food and Drug Law Journal, vol. 55 (2000), p. 120.

Draft Device Broadcast Advertising Guidance would apply the same, less burdensome,

brief summary requirement to DTC broadcast ads for restricted medical devices.

21 U.S.C. § 352(n).

FDA, “[DRAFT] Guidance for Industry: Brief Summary: Disclosing Risk Information

in Consumer-Directed Print Advertisements, Division of Drug Marketing, Advertising, and

Communications,” CDER, Jan. 2004, at [http://www.fda.gov/cder/guidance/5669dft.pdf].

Ibid.

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the FDA-approved patient labeling in full.62 For the second option, the manufacturer

could print a portion of the patient labeling, including the risk information but

omitting, for example, directions for use. The third option relates to a proposed

“highlights” section of the professional labeling.63 But because this highlights

section would be written for medical professionals, FDA recommends in the brief

summary guidance draft that it be rewritten to be understandable to consumers.

The agency has asked drug firms to consider the costs and benefits of each of

these options and decide which option is best. Supporters say that less type and

lower information volume will mean lower advertising costs, and consumer oriented

risk information will mean that the information is more useful. Critics argue that this

approach may be appropriate for only a small subset of products. They also argue

that FDA should be going further in developing guidelines for the kind of risk

disclosures that actually allow patients to use them as a basis for further discussion

with a health professional.64 After reviewing the three January 2004 draft guidance

documents at FDA’s request, Federal Trade Commission staff agreed that presenting

risk information in more accessible language would be better than reprinting the brief

summary. The FTC report recommended, however, that FDA conduct consumer

research to assess the various types of risk presentation, the influence on industry’s

advertising incentives, and other costs and benefits of the proposed formats and

others to “determine ... the most effective means of providing drug risk information

in DTC print ads.”65

Disease-Awareness Guidance. The agency clarifies in this guidance when

it does and does not have jurisdiction over help-seeking ads that encourage

consumers to seek treatment for a medical condition.66 The draft “Disease

This could be the Patient Package Insert (PPI), special patient materials that FDA

approves that are used to instruct patients about the safe use of the prescription product in

simple, easily understood language. These materials may be given to patients by their health

care provider or pharmacist and are part of FDA-regulated product labeling. They are based

on the approved labeling of the drug.

FDA, “[DRAFT] Guidance for Industry: Content and Format of the Adverse Reactions

Section of Labeling for Human Prescription Drugs and Biologics,” May 2000, at

[http://www.fda.gov/cder/guidance/1888dft.pdf].

Rosemary C. Harold and John F. Kamp, “Grounding Regulations in Behavior Science:

Strengthening FDA’s Approach to DTC Risk Disclosures,” Update, Food and Drug Law,

Regulation, and Education, no. 6 (Nov./Dec. 2004), pp. 8-12.

Federal Trade Commission, “In the Matter of Request for Comments on Agency Draft

Guidance Documents Regarding Consumer-Directed Promotion,” Docket No. 2004D-0042.

May 10, 2004, at [http://www.ftc.gov/os/2004/05/040512dtcdrugscomment.pdf]; and FTC,

“FTC Staff Provides Comments to FDA on Direct-to-Consumer Drug and Device Ads,”

FTC: For the Consumer, May 12, 2004, at [http://www.ftc.gov/opa/2004/05/dtcdrugs.htm].

The Federal Trade Commission has jurisdiction over these types of communications and

could investigate and challenge ads if they appeared to be “unfair or deceptive acts or

practices” (15 U.S.C. § 45, in general; 15 U.S.C. § 52, specific application to drugs and

devices).

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Awareness Guidance”67 provides recommendations on how to make these ads

perceptually distinctive from product advertising. Both FDA and FTC officials are

watchful when marketers of the only product in a therapeutic category have a

commercial interest in funding a disease awareness ad.68

FDA’s Enforcement Activities

While the law and regulations do not give FDA prior approval authority for

prescription drug advertising, the law does give FDA authority to review the accuracy

of claims in a prescription drug’s promotion. In 2003, FDA received approximately

38,000 ads (known as submissions to the agency) from drug sponsors.69 These

submissions include all types of promotional materials, both broadcast and print

advertisements, and promotional labeling for new products, directed at all audiences

including consumers and health care professionals. In 2003, the agency reviewed

161 broadcast and 221 print DTC ads that had been voluntarily submitted by the

manufacturers to the agency for review prior to release to the public. These voluntary

submissions give FDA an opportunity to object to ads that either omit or minimize

risks, promote unapproved uses of the drug or make unsubstantiated claims about

how effective and safe the drugs are or how effective the advertised drugs are relative

to competitive products.70 In addition, the agency has found that some ads obscure

the warning information that is required.

If the FDA feels that an advertisement for a drug that is before the public does

not contain the required information or is false or misleading, it can respond through

a variety of enforcement actions.71 In most cases, the agency asks the company to

withdraw voluntarily the violative ad. It can send a letter to the company (called an

“untitled letter” by the agency) warning that the advertisement violates the FFDCA.

Often, the letter states that the ad is “misleading” because it overstates or guarantees

the product’s effectiveness, expands the population approved for treatment, or

minimizes the risks of the product. The letter asks that the ad be stopped

immediately. Another letter that FDA can send is a “Warning Letter” directed at

more serious violations.

Food and Drug Administration, “Draft Guidance for Industry: ‘Help-Seeking’ and Other

Disease Awareness Communications by or on Behalf of Drug and Device Firms,” Jan. 2004,

available at [http://www.fda.gov/cder/guidance/6019dft.doc].

“Disease Awareness Ad Guidance Stresses Need for ‘Distinct’ Messages,” The Pink

Sheet, [F-D-C Reports, Inc., Chevy Chase, MD], Feb. 9, 2004, p. 6.

The total submission number was split between 32,000 pieces of promotional materials

directed to health care professionals (such as pens, pins, and labeling) and 6,000 pieces of

promotional material directed at consumers such as booklets, brochures and videos (author’s

conversation with FDA officials).

Thomas W. Abrams, Division of Drug Marketing, Advertising, and Communications,

Food and Drug Administration, “DDMAC Update-Regulation of Prescription Drug

Promotion,” Feb. 26, 2004. Slide presentation found at [http://www.fda.gov/cder/ddmac/

Presentations/DIA/DIA%20022604%20Slides.ppt].

Between 1999 and April 2002, FDA reviewed the content of 706 broadcast advertisements

for 76 different pharmaceuticals. Forty-six broadcast ads, about 6.5%, warranted some type

of regulatory notice.

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In 2004, the agency sent 23 letters concerning violative promotional labeling,

broadcast ads, or print ads that did not comply with regulations. In one case, on

December 21, 2004, FDA issued an “untitled letter” stating that a “patient safety”

print ad made false or misleading safety claims that minimize the risks associated

with Crestor (See text box).72 The company had placed that ad in several newspapers

defending its brand drug in response to recent congressional testimony from an FDA

safety official who had named Crestor among five marketed drugs that, he said,

present significant safety risks.73

A Recent “Untitled Letter”

On December 21, 2004, FDA sent an “untitled letter” to AstraZeneca stating that the

firm’s ads run in large national papers on November 23 and 24, 2004 made “false and

misleading safety claims that minimize the risks associated with Crestor.” FDA claimed

that the ad suggests that Crestor is safer than was demonstrated by substantial evidence

and clinical experience. The letter stated that the company had agreed to a risk

management plan whereby patients in three clinical trials taking a 40 mg dose of Crestor

would be given regular renal monitoring. The 40 mg dose was also to be given only to

patients with severe hypercholesterolemia who did not respond to other treatments.

According to FDA’s letter, the ad headlined the sentence, “You can be assured that at

AstraZeneca, patient safety is our number one priority.” The untitled letter also said that

it appeared to the agency that the Company was seeking to assure readers that Crestor is

“more effective and just as safe as the leading medications in its class.” [emphasis

added] The untitled letter stated that FDA is not aware of evidence or experience

demonstrating that all doses of Crestor are “just as safe” as other statins. Similarly, FDA

expressed concern about the section of the ad that stated: “The FDA has confidence in

the safety and efficacy of CRESTOR. ... The scientists at the FDA who are responsible for

the approval and ongoing review of CRESTOR have, as recently as last Friday, publicly

confirmed that CRESTOR is safe and effective; and that the concerns that have been

raised have no medical or scientific basis.” FDA states that the ad misleadingly suggests

that the Agency does not believe that Crestor poses safety concerns. For this claim, the

AstraZeneca ad cites “www.fda.gov accessed on 11/19/04.” In its letter, FDA notes that

there is no statement on the website by FDA concluding that the concerns about Crestor

have no medical or scientific basis. The letter further states that recent reported

statements made by the Agency contradict that conclusion, referring to an article entitled

“Campaign Waged Against Crestor” appearing the previous week (on November 18,

2004) in the Washington Post. In describing the safety concerns raised by the consumer

advocacy group Public Citizen about Crestor, the article quotes Dr. Steven Galson,

Acting Director of the FDA’s Center for Drug Evaluation and Research, as saying: “[the

Agency] has been very concerned about Crestor since the day it was approved, and we’ve

been watching it very carefully” and that the Agency is “concerned about the same issues

with Crestor as Public Citizen.” FDA’s December 21, 2004 untitled letter therefore

requested AstraZeneca to immediately cease the dissemination of violative promotional

materials for Crestor. The FDA sent another untitled letter to AstraZeneca on March 8,

2005 concerning another Crestor ad. In both letters, FDA requested that the company’s

reply, due in 10 business days, include its plan for discontinuing use of such materials.

Source: See [http://www.fda.gov/cder/warn/warn2004.htm]

cder/warn/warn2005.htm].

and

[http://www.fda.gov/

21 U.S.C. § 352n; 21 C.F.R. §202.1(e)(6)(i).

U.S. Congress, Senate Committee on Finance, FDA, Merck and Vioxx: Putting Patient

Safety First?, hearing, 108th Cong., 2nd sess., Nov. 18, 2004, available at

[http://finance.senate.gov/sitepages/hearing111804.htm].

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Of the 23, 12 were actual Warning Letters for violative broadcast ads concerning

print materials that did not comply with the regulations.74 Warning Letters state that,

in addition to stopping the violative activity, the company must take corrective steps

by disseminating corrective information to the audience of the violative promotional

materials such as physicians, pharmacists, and patients. At times, companies must

run ads in the same media to correct the misleading impressions. Usually, the

companies respond immediately to the Letter.

If Warning Letters fail to rectify the situation, FDA can work with the

Department of Justice to seek injunctions against companies, or criminally prosecute

firms, or FDA can seize products deemed to be misbranded by intentional and/or

serious misstatements, or can withdraw the drug’s approval. For example, in 1995,

a prominent company pleaded guilty to having promoted its acne treatment drug for

use in treating sun-wrinkled or “photoaged” skin. The company paid a $5 million

fine and $2.5 million for the costs of the investigation. In fact, however, very few

cases have been brought to court for resolution.

The agency has had its authority to regulate DTC advertisements and other

forms of prescription drug promotion examined in the courts. The rulings

emphasized that the agency should not impose unnecessary restrictions on

“commercial speech.”75 In reaction to these decisions, on May 16, 2002, FDA

published in the Federal Register a notice requesting comment by July 30, 2002, on

“commercial speech” issues under the First Amendment.76 In the notice, FDA

mentions an unfavorable court decision on its regulation of commercial speech.77

The finding led the agency to question whether it continues to have legal credibility

to sustain its authority to carry out its public health duties, and, in addition, whether

its position on promotional speech about prescription drugs is valid.78 The notice

solicited public comments about FDA’s legal basis for its regulations, guidances,

See [http://www.fda.gov/cder/warn/warn2004.htm].

George W. Evans and Arnold I. Friede, “The Food and Drug Administration’s Regulation

of Prescription Drug Manufacturer Speech: A First Amendment Analysis,” Food and Drug

Law Journal, vol. 58, no. 3 (2003), pp. 365-437.

U.S. Department of Health and Human Services, Food and Drug Administration, Request

for Comment on First Amendment Issues. 67 Federal Register 34942 (May 16, 2002). See

CRS Report 95-815, Freedom of Speech and Press: Exceptions to the First Amendment, by

Henry Cohen.

Thompson v. Western States Medical Center, 535 U.S. 357 (April 29, 2002). In this case,

the Supreme Court struck down a pharmacy-compounding provision in the FDA

Modernization Act (FDAMA). Pharmacy compounding involves a pharmacist mixing a

slightly altered version of a drug for an individual, such as removing a preservative for a

patient who is allergic to that preservative. The FDAMA provision said that a drug could

be compounded only if the physician or pharmacist does not advertise or promote the

compounding of a particular drug, class, or type of drug. The Supreme Court ruled that the

provision’s advertising restrictions violate the First Amendment to the Constitution. FDA

Week, June 21, 2002.

“FDA Seeks Comment on Ad Regs: Can Rx Be More Regulated Than OTCs?” The Pink

Sheet, vol. 64, no. 20 (May 20, 2002), p. 14.

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policies, and practices to ensure the agency continues to comply with the law. It

reads:

Is FDA’s current position regarding direct-to-consumer and other advertisements

consistent with empirical research on the effects of those advertisements, as well

as with relevant legal authority? What are the positive and negative effects, if

any, of industry’s promotion of prescription drugs ...? Does the current

regulatory approach and its implementation by industry lead to over-prescription

of drugs? Do they increase physician visits or patient compliance with

medication regimes? Do they cause patient visits that lead to treatment for

under-diagnosed diseases? Does FDA’s current approach and its implementation

by industry lead to adequate treatment for under-diagnosed diseases? Do they

lead to adequate patient understanding of the potential risks associated with use

of drugs? Does FDA’s current approach and its implementation by industry

create any impediments to the ability of doctors to give optimal medical advice

or prescribe optimal treatment?79

FDA extended the deadline for comments but has not published any formal response.

In another section of the notice, FDA asked whether it should distinguish between

labels and advertisements in the regulation of commercial speech and whether both

should be subject to the same degree of regulation as they are currently.

The General Accounting Office (GAO — now called the Government

Accountability Office) found in 2002 that FDA’s oversight of DTC advertising is

generally effective at halting the dissemination of ads that it reviews and identifies

as misleading. However, GAO also stated that FDA’s oversight has limitations in

two areas. The agency cannot verify that it receives all newly disseminated ads from

drug companies, nor does the agency have the ability to quickly issue regulatory

letters after an violation is identified. FDA/DDMAC used to issue letters a few days

after determining an ad was violative but because of a policy switch all letters must

now go through FDA’s Office of the Chief Counsel where the letters are reviewed

for legal sufficiency and consistency with agency policy. This review can take

between 13 and 78 days according to GAO.80 According to FDA officials, DDMAC

and the Office of Chief Counsel have now streamlined this process to five days for

warning letters and 15 days for untitled letters.81

In addition, in his last speech as the outgoing Chief Counsel of FDA, Daniel

Troy, in November 2004, claimed that the courts had reaffirmed the authority of FDA

to regulate commercial free speech under the First Amendment with regard to DTC

advertising. In the fall of 2004, he established an inter-center coordinating group to

develop guidance documents that will bring transparency to FDA’s regulation of

Food and Drug Administration, “Request for Comment on First Amendment Issues,” 67

Federal Register 34943(May 16, 2002).

U.S. General Accounting Office, Prescription Drugs: FDA Oversight of Direct-toConsumer Advertising Has Limitations, GAO-03-177, Oct. 2002.

“FDA Chief Counsel Warning Letter Review to Continue After Troy’s Departure,” The

Pink Sheet, Nov. 22, 2004, p. 14.

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promotional communication, and establish common standards for regulating

commercial communications across all FDA’s product areas.82

Funding

Two offices within FDA handle the bulk of review and enforcement activities

regarding drug promotion: the Division of Drug Marketing, Advertising, and

Communications (DDMAC), and the Office of Drug Safety (ODS), both units within

the Center for Drug Evaluation and Research (CDER). Table 5 gives the total

resources for DDMAC and for the review of DTC advertisements. It also shows that

the resources used for review of DTC advertisements decreased not only as a

percentage of the total division resources, but also in actual dollars between FY2003,

and FY2005.

Table 5. Appropriations for CDER’s Division of Drug Marketing,

Advertising, and Communications FY2003, FY2004 (actual),

FY2005 (projected), and FY2006 (requested)

FY2003

(actual)

FY2004

(actual)

FY2005

(projected)

FY2006

(requested)

Total appropriation for

Division of Drug

Marketing, Advertising, and

Communications (DDMAC)

$4,167,242

$3,615,357

$3,870,979

$4,255,979

Appropriation for the

review

DTC