United States Government Accountability Office

GAO Report to Congressional Requesters

PRESCRIPTION 

DRUGS 

Improvements Needed 

in FDA’s Oversight of 

Direct-to-Consumer 

Advertising 

November 2006 

 

GAO-07-54 
What GAO Found

United States Government Accountability Office

Why GAO Did This Study

Highlights

Accountability Integrity Reliability

November 2006

PRESCRIPTION DRUGS 

Improvements Needed in FDA’s 

Oversight of Direct-to-Consumer 

Advertising 

Highlights of GAO-07-54, a report to 

congressional requesters 

The Food and Drug Administration 

(FDA) is responsible for overseeing

direct-to-consumer (DTC) 

advertising of prescription drugs. 

If FDA identifies a violation of laws

or regulations in a DTC advertising

material, the agency may issue a 

regulatory letter asking the drug

company to take specific actions. 

GAO was asked to discuss 

(1) trends in drug company 

spending on DTC advertising and 

other activities; (2) what is known 

about the relationship between 

DTC advertising and drug spending

and utilization; (3) the DTC 

advertising materials FDA reviews;

(4) the number of regulatory letters

that cited DTC materials and FDA’s 

process for issuing those letters; 

and (5) the effectiveness of these 

letters at limiting the dissemination 

of violative DTC advertising. GAO 

reviewed research literature, 

analyzed FDA’s processes, and

examined FDA documentation. 

What GAO Recommends

GAO recommends that FDA 

(1) document criteria for 

prioritizing DTC materials for 

review, (2) systematically apply its 

criteria to materials it receives, and

(3) track which materials it

reviews. In its comments on a draft

of this report, HHS disagreed with

the recommendations, stating that 

they would require vastly increased

staff. GAO believes that FDA 

already has most of the information 

that would be required to establish 

a systematic process for screening 

DTC materials. 

Drug company spending on DTC advertising—such as that on television and 

in magazines—of prescription drugs increased twice as fast from 1997

through 2005 as spending on promotion to physicians or on research and 

development. Over this period, drug companies spent less each year on DTC 

advertising ($4.2 billion in 2005) than on promotion to physicians 

($7.2 billion in 2005) or research and development ($31.4 billion in 2005). 

Studies GAO reviewed suggest that DTC advertising has contributed to 

increases in drug spending and utilization, for example, by prompting 

consumers to request the advertised drugs from their physicians, who are

generally responsive to these requests. Evidence suggests that the effect of 

DTC advertising on consumers can be both positive, such as encouraging 

them to talk to their doctors, and negative, such as increased use of 

advertised drugs when alternatives may be more appropriate. 

 

FDA reviews a small portion of the DTC materials it receives. To identify 

materials that have the greatest potential to impact public health, FDA has 

informal criteria to prioritize materials for review. However, FDA has not 

documented these criteria, does not apply them systematically to all of the 

materials it receives, and does not track information on its reviews. As a 

result, the agency cannot ensure that it is identifying or reviewing those 

materials that it would consider to be the highest priority. 

FDA has taken longer to draft and review regulatory letters and the agency

has issued fewer letters per year since 2002, when legal review of all draft 

regulatory letters was first required. From 2002 through 2005, from the time

FDA began drafting a regulatory letter for a violative DTC material, it took 

the agency an average of 4 months to issue a regulatory letter, compared 

with an average of 2 weeks from 1997 through 2001. FDA has issued about 

half as many regulatory letters per year since the 2002 policy change. 

The effectiveness of FDA’s regulatory letters at halting the dissemination of 

violative DTC materials has been limited. The 19 regulatory letters FDA 

issued in 2004 and 2005 were issued an average of 8 months after the 

materials were first disseminated. By the time FDA issued these letters,

companies had already discontinued use of more than half of the violative 

materials. When the cited materials were still being disseminated, drug 

companies complied with FDA’s requests to remove the materials, and 

identified and removed other materials with similar claims. FDA’s issuance 

of regulatory letters did not always prevent drug companies from later 

disseminating similar violative materials for the same drugs. These issues are 

not new. In 2002, GAO reported that, by delaying the issuance of regulatory 

letters, the 2002 policy change had adversely affected FDA’s ability to 

enforce compliance. At that time, GAO recommended, and FDA agreed, that 

letters be issued more quickly. GAO continues to believe this is necessary in 

order to limit consumers’ exposure to false or misleading advertising. 

www.gao.gov/cgi-bin/getrpt?GAO-07-54.

To view the full product, including the scope 

and methodology, click on the link above. 

For more information, contact Marcia Crosse 

at (202) 512-7119 or crossem@gao.gov. 
Contents 

Letter 1

Results in Brief 5 

Background 8

Drug Company Spending on DTC Advertising Has Increased More 

Rapidly Than Spending on Promotion to Physicians or Research 

and Development 12 

Research Suggests DTC Advertising Increases Drug Spending and 

Utilization 14

FDA Reviews a Small Portion of DTC Materials and Cannot Ensure 

It Is Reviewing the Highest-Priority Materials 17 

Since the 2002 Policy Change, FDA’s Process for Issuing 

Regulatory Letters Has Taken Longer and the Agency Has Issued 

Fewer Letters 21 

Effectiveness of FDA Regulatory Letters at Halting Dissemination 

of Violative DTC Materials Has Been Limited 27 

Conclusions 34

Recommendations for Executive Action 34 

Agency Comments and Our Evaluation 35 

Appendix I Scope and Methodology 38 

Appendix II Comments from the Department of Health and 

Human Services 43 

Appendix III GAO Contact and Staff Acknowledgments 47 

Tables 

Table 1: Prescription Drug Promotion and Research and 

Development, 1997 through 2005 13 

Table 2: Drugs for Which FDA Cited the Same Specific Violative 

Claim in More Than One Regulatory Letter 33 

Table 3: FDA Regulatory Letters Issued from 2004 through 2005 

That Cited DTC Materials 40 

Page i GAO-07-54 Prescription Drug Advertising
Figures 

Figure 1: Number of Final DTC and Consumer-Directed Materials 

Submitted to FDA, 1999 through 2005 18 

Figure 2: Average Months to Issue Regulatory Letters Citing 

Violative DTC Materials, 1997 through 2005 22 

Figure 3: Number of Regulatory Letters FDA Issued That Cited 

DTC Advertising Materials, 1997 through 2005 25 

Figure 4: Timelines for 19 Regulatory Letters Issued from 2004 

through 2005 and the Cited DTC Materials 29 

Abbreviations 

DDMAC Division of Drug Marketing, Advertising, and 

 Communications 

DTC direct-to-consumer 

FDA Food and Drug Administration 

HHS Department of Health and Human Services 

OCC Office of the Chief Counsel 

PhRMA Pharmaceutical Research and Manufacturers of America 

This is a work of the U.S. government and is not subject to copyright protection in the 

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Page ii GAO-07-54 Prescription Drug Advertising
United States Government Accountability Office

Washington, DC 20548 

November 16, 2006 

The Honorable Bill Frist 

Majority Leader 

United States Senate 

The Honorable Charles E. Grassley 

Chairman 

Committee on Finance 

United States Senate 

The Honorable Herbert Kohl 

Ranking Minority Member 

Special Committee on Aging 

United States Senate 

Spending on prescription drugs, which accounted for about 11 percent of

total health care spending in 2004,1

 has increased more rapidly since 1997

than any other component of health care spending in the United States. 

One factor, among many, that has been cited as contributing to this trend 

is the advertising of prescription drugs directly to consumers. Direct-toconsumer (DTC) advertising includes a range of media, such as television, 

radio, magazines, newspapers, and the Internet.2

 The pharmaceutical

industry spent more than $4.2 billion in 2005 to advertise prescription 

drugs to consumers.3

 Supporters of DTC advertising maintain that it 

educates consumers, helps to get patients into needed treatment, and 

 1

Centers for Medicare & Medicaid Services, “Highlights,” National Health Expenditure 

Data, Historical (Baltimore, Md.: Centers for Medicare & Medicaid Services, 2006), 

http://www.cms.hhs.gov/NationalHealthExpendData/ (accessed July 31, 2006).

2

In addition to DTC advertising, drug companies promote their drugs through other 

consumer-directed materials—such as informational videos or brochures—that are

intended to be given to consumers by medical professionals. Drug companies also promote 

prescription drugs to medical professionals, primarily by using sales representatives to 

provide information about prescription drugs and by advertising in professional journals.

Further, drug companies provide free samples of prescription drugs that medical 

professionals can give to their patients. 

3

IMS Health Inc., “Total U.S. Promotional Spend by Type, 2005,” Top-Line Industry Data

(Fairfield, Conn.: IMS Health Inc., 2006), http://www.imshealth.com/ (accessed Aug. 21, 

2006). 

Page 1 GAO-07-54 Prescription Drug Advertising
saves money by reducing spending on other medical care. Critics contend 

that it can be misleading, encourages inappropriate increases in 

prescription drug use, and creates unnecessary costs for the U.S. health 

care system. 

The Department of Health and Human Services’ (HHS) Food and Drug 

Administration (FDA) regulates the promotion and advertising of 

prescription drugs, including DTC materials and materials directed to 

medical professionals, to ensure that they are not false or misleading and 

otherwise comply with applicable laws and regulations.4

 This oversight 

function is carried out by the Division of Drug Marketing, Advertising, and 

Communications (DDMAC) within FDA’s Center for Drug Evaluation and 

Research.5

 FDA regulations require that drug companies submit final 

advertising materials to FDA at the time they are first disseminated to the 

public.6

 In addition, drug companies sometimes voluntarily submit draft 

versions of DTC advertising materials to FDA prior to their release in 

order to obtain advisory comments from the agency. 

If FDA identifies a violation in a disseminated DTC advertisement, such as

a false or misleading safety or effectiveness claim, the agency may issue a 

regulatory letter. In these letters, FDA asks drug companies to take 

specific actions such as stopping the dissemination of the advertisement 

and, if FDA finds the violation to be particularly serious, running another 

advertisement to correct misleading impressions left by the violative 

advertisement. Regulatory letters for these violative advertisements are 

drafted by DDMAC. Since January 31, 2002, at the direction of HHS, all 

draft FDA regulatory letters, including the letters drafted by DDMAC, are 

reviewed and approved by FDA’s Office of the Chief Counsel (OCC) before 

they are issued in order to ensure the letters’ “legal sufficiency and 

 4

See 21 U.S.C. § 352(n), 21 C.F.R. § 202.1(e)(2006). FDA’s authority does not extend to

“help-seeking” advertisements—those that do not identify prescription drugs by name, but

rather discuss a disease or condition and advise the audience to “see your doctor” for 

possible treatments. In addition, the Federal Trade Commission has primary oversight 

responsibility for the regulation of advertising for over-the-counter drugs. 

5

Other centers within FDA are responsible for overseeing promotion and advertising of 

biologics—such as vaccines and blood products—and electronic products emitting 

radiation. 

6

21 C.F.R. § 314.81(b)(3)(i)(2006). 

Page 2 GAO-07-54 Prescription Drug Advertising
consistency with agency policy.”7

 In October 2002, we reported that the 

2002 policy change had adversely affected FDA’s ability to enforce 

compliance with its regulations by delaying the issuance of regulatory 

letters and potentially allowing misleading advertisements to continue to 

be disseminated.8

 As we noted in that report, issuing regulatory letters 

quickly after violative materials are disseminated is a key component of 

FDA’s oversight of DTC advertising because any inaccurate impressions of 

a drug that are caused by a misleading advertisement are minimized if the 

advertisement is quickly removed. We recommended that FDA take action 

to reduce the amount of time for internal review of draft regulatory letters

citing violative DTC materials. In its response to our recommendation, 

FDA wrote that it had established a goal of issuing regulatory letters 

“within 15 working days of review at OCC.”9

As a result of the increased spending on prescription drugs and concerns 

about the effect of DTC advertising, you asked us to examine trends in 

DTC advertising and FDA’s regulation and oversight of this advertising. In

this report, we discuss (1) trends in pharmaceutical industry spending on 

DTC advertising, as compared to promotion to medical professionals, and 

research and development; (2) what is known about the relationship 

between DTC advertising and prescription drug spending and utilization 

patterns; (3) the DTC advertising materials FDA reviews; (4) the number 

of FDA regulatory letters that cited DTC advertising materials and FDA’s 

process for issuing those letters; and (5) the effectiveness of FDA’s 

regulatory letters at limiting the dissemination of false or misleading DTC 

advertising.

To examine trends in pharmaceutical industry spending on DTC 

advertising, promotion to medical professionals, and research and 

development of new drugs, we reviewed publicly reported data. For 

overall drug company spending from 1997 through 2005 on DTC 

advertising and promotion to medical professionals, we obtained data

 7

FDA issues regulatory letters on a variety of topics as a means of bringing about voluntary 

compliance with applicable laws and regulations. In a November 29, 2001, memo the

Deputy Secretary of HHS instructed FDA that no regulatory letters could be issued until 

FDA’s OCC reviewed them. According to FDA officials, OCC implemented this policy 

change on January 31, 2002. Prior to this policy change, OCC review and approval of draft 

regulatory letters before their issuance was not required. 

8

GAO, Prescription Drugs: FDA Oversight of Direct-to-Consumer Advertising Has 

Limitations, GAO-03-177 (Washington, D.C.: Oct. 28, 2002). 

9

GAO-03-177, p. 33. 

Page 3 GAO-07-54 Prescription Drug Advertising
from IMS Health Inc. For 2005, we reviewed detailed data from Neilsen 

Monitor-Plus on DTC advertising by prescription drug. Some types of 

promotional spending on DTC advertising and promotion to medical 

professionals—such as spending on professional meetings and spending 

on promotion to nurse practitioners—are not captured in the data we 

examined. In addition, we obtained data from the Pharmaceutical 

Research and Manufacturers of America (PhRMA)—which represents U.S. 

pharmaceutical research and biotechnology companies—on drug 

company spending for the research and development of new drugs from 

1997 through 2005. Based on our review of related documentation and our 

discussions with the data providers, we determined that the data we 

present were sufficiently reliable for our use. To examine the relationship 

between DTC advertising and prescription drug spending and utilization, 

we reviewed 64 peer-reviewed journal articles, dissertations, and industry 

articles published from 1982 through 2006. To examine the DTC 

advertising materials that FDA reviews, we obtained data from FDA on the 

number and type of advertising materials that it received and reviewed 

from 1997 through 2005. Based on interviews with FDA officials and 

reviewers and our review of related documentation, we determined that 

these data were sufficiently reliable for the purposes of this report. To 

examine the number of FDA regulatory letters that cite violative DTC 

advertising materials and FDA’s process for issuing those letters, we 

reviewed all regulatory letters issued by FDA from 1997 through 2005 

citing prescription drug promotion. We identified 135 regulatory letters 

issued during this period that cited one or more violative DTC advertising 

materials.10 We also reviewed FDA documentation on the length of the 

agency’s process for issuing the 135 regulatory letters. Because FDA does 

not track when the agency identifies a violation, we used the date on 

which reviewers first began drafting a regulatory letter as the earliest date

in this process. To examine the effectiveness of the regulatory letters FDA 

issued from 2004 through 2005 that cite violative DTC advertising 

materials, we obtained additional details about the timeliness of the letters

and drug companies’ compliance with any corrective action requested by

FDA. We reviewed the content of the regulatory letters FDA issued from 

1997 through 2005 to identify the violations cited; we did not evaluate the 

appropriateness of cited violations or evaluate the legal sufficiency of 

these letters. We also did not examine the effectiveness of FDA’s review of 

 10We excluded regulatory letters that cited only materials intended to be given to 

consumers by medical professionals or that cited only materials directed to medical 

professionals. FDA officials confirmed that the 135 letters included all letters that cited 

DTC materials. 

Page 4 GAO-07-54 Prescription Drug Advertising
draft materials at preventing potentially violative materials from being 

disseminated. Finally, our examination included only DDMAC’s oversight 

of prescription drug promotion and advertising; we did not examine 

oversight by other parts of FDA of promotion for other types of medical 

products. (For additional information on our methodology, see app. I.) We 

conducted our work from January 2006 through November 2006 in 

accordance with generally accepted government auditing standards. 

Drug company spending on DTC advertising has increased twice as fast as

spending on promotion to physicians or on the research and development 

of new drugs. According to publicly reported data, from 1997 through 

2005, spending on DTC advertising increased almost 20 percent each year. 

Over the same time period, spending on drug promotion to physicians and 

spending on research and development each increased by about 9 percent 

annually. Drug companies spent less in 2005 on DTC advertising 

($4.2 billion) than on promotion to physicians ($7.2 billion) or research 

and development ($31.4 billion). 

Results in Brief 

Studies we reviewed suggest that while DTC advertising increases 

prescription drug spending and utilization, it can have both positive and 

negative effects on consumers. The studies we reviewed found that 

increases in DTC advertising have contributed to overall increases in 

spending on both the advertised drug itself and on other drugs that treat 

the same conditions. For example, one study of 64 drugs found a median

increase in sales of $2.20 for every $1 spent on DTC advertising. Consumer 

surveys suggest that DTC advertising increases utilization of drugs by 

prompting some consumers to request the advertised drugs from their 

physicians, who studies find are generally responsive to these requests. 

The surveys we reviewed found that between 2 and 7 percent of 

consumers who saw DTC advertising requested and ultimately received a

prescription for the advertised drug. Studies about DTC advertising and 

the increased utilization of prescription drugs it can prompt suggest that 

its effect on consumers can be both positive, such as encouraging them to 

talk to their doctors about previously undiagnosed conditions, and 

negative, such as encouraging increases in prescriptions for advertised 

drugs when alternatives may be more appropriate. 

FDA reviews a small portion of the DTC materials it receives, and the 

agency cannot ensure that it is identifying for review the materials it 

considers to be highest priority. Since FDA created a group in 2002—with 

an initial staff allocation of one group leader, four reviewers, and two 

social scientists—with specific responsibility for reviewing DTC materials, 

Page 5 GAO-07-54 Prescription Drug Advertising
the number of DTC materials FDA receives each year has almost doubled.

While FDA officials told us the agency prioritizes the review of materials 

that have the greatest potential to impact public health, the agency has not 

documented criteria to make this prioritization. FDA officials identified 

informal criteria that reviewers consider when identifying materials for 

review. For example, FDA officials told us that they review all final and 

draft DTC television advertisements that FDA receives because these 

materials are likely to be widely disseminated to consumers. The agency

also places a priority on draft versions of other DTC materials because this 

provides the agency with an opportunity to identify problems before the 

materials are disseminated to consumers. However, FDA does not 

systematically apply its informal criteria to all of the DTC materials it 

receives. Instead, the agency relies on reviewers to be aware of the 

materials the agency has received and accurately apply the various criteria 

to each of the materials. Furthermore, FDA cannot determine whether a 

particular material has been reviewed. As a result, the agency cannot 

ensure that it is identifying and reviewing the highest-priority materials. 

Since the 2002 policy change requiring legal review of all draft regulatory

letters, FDA’s process for drafting and issuing letters has taken longer and

the agency has issued fewer letters per year. From 2002 through 2005, 

once the agency began drafting a regulatory letter for violative DTC 

materials, it took an average of 4 months to issue the letter, while it took 

an average of 2 weeks to issue a letter from 1997 through 2001. FDA 

officials told us that the policy change contributed to the lengthened 

review by creating additional levels of review and making it necessary for 

the DDMAC reviewers who draft the regulatory letters to do substantially 

more work to prepare for and respond to comments from OCC. Since the 

policy change, FDA has issued about half as many regulatory letters citing 

violative DTC advertisements per year—between 8 and 11 letters annually 

from 2002 through 2005, compared with 15 to 25 letters annually from 1997 

through 2001. FDA’s regulatory letters sometimes cited more than one 

DTC material and more than one violation per material. Commonly cited 

violations included failure of the material to accurately communicate 

information about the safety of the drug, overstatement of the drug’s 

effectiveness, and use of misleading comparative claims. FDA officials told

us that the agency issues letters only for the violative DTC materials that it

considers the most serious and most likely to impact consumers’ health. 

The effectiveness of FDA’s regulatory letters at halting the dissemination

of violative DTC materials has been limited. The 19 regulatory letters FDA 

issued from 2004 through 2005 were issued an average of 8 months after 

the violative materials were first disseminated to consumers. By the time 

Page 6 GAO-07-54 Prescription Drug Advertising
these regulatory letters were issued, drug companies had already 

discontinued use of more than half of the violative advertising materials. 

When cited materials were still being disseminated, drug companies 

complied with FDA’s requests to remove the materials in response to 

FDA’s letters. In addition, as requested in the regulatory letters, drug 

companies identified and removed additional materials with similar 

claims. Further, for the 6 letters in which FDA requested that drug 

companies issue new advertising materials to correct the misimpressions 

left by the violative materials cited in the letters, drug companies 

disseminated the corrective materials. These corrections were not 

disseminated to consumers until 5 months or more after FDA issued the 

regulatory letter. Despite halting the dissemination of both cited and other 

violative materials at the time a letter was issued, FDA’s issuance of 

regulatory letters has not always prevented drug companies from later 

disseminating similar violative materials for the same drugs. We found that 

of the 89 drugs for which FDA cited violative DTC materials from 1997 

through 2005, 25 drugs had DTC materials cited in more than one 

regulatory letter, sometimes for similar types of violations. In our 2002 

report, we expressed similar concerns about the length of time it takes 

FDA to issue regulatory letters and recommended that HHS take steps to 

reduce the time that FDA’s DTC draft regulatory letters are under review. 

HHS agreed in its written response to that report that letters needed to be 

issued more quickly and established a goal of issuing the letters “within 15 

working days of review at OCC.” Given our findings in this report, we 

continue to believe that letters must be issued more quickly in order to 

limit consumers’ exposure to false or misleading claims. 

To improve FDA’s processes for identifying and reviewing final and draft 

DTC advertising materials, we are making recommendations to the Acting

Commissioner of FDA. Specifically, we recommend that FDA 

(1) document criteria for prioritizing materials that it receives for review, 

(2) systematically apply its documented criteria to all of the materials it 

receives, and (3) track which materials have been reviewed.

In its comments on a draft of this report, HHS generally agreed with our 

description of FDA’s oversight of DTC advertising but disagreed with our 

recommendations and some aspects of our conclusions. Specifically, HHS

commented that implementing our recommendations would require vastly 

increased staff. HHS also expressed concern that our draft report 

criticized the length of time it takes to issue regulatory letters since the 

policy change requiring legal review, without adequately addressing the 

underlying purpose of that review. We believe it is important for FDA to 

develop a more complete and systematic process for screening the 

Page 7 GAO-07-54 Prescription Drug Advertising
materials it receives, in order to ensure that FDA is reviewing the highestpriority materials. We do not agree that such a process would require that

every DTC material be reviewed in detail, as HHS contends. Instead, we 

believe that FDA should apply its criteria as a screening mechanism to all 

submitted materials to determine the priority of materials for review. 

Furthermore, FDA already has most of the information that would be 

necessary to establish a system to screen submitted materials against 

these criteria. Additionally, we agree with HHS that it is important to 

ensure that FDA’s regulatory letters are legally supportable. As FDA 

agreed in its response to our 2002 report, however, it is also important for 

letters to be issued quickly. We believe that it is important for letters to be 

issued in a timely manner if they are to have an impact on halting the 

dissemination of the violative materials that the letters cite and reducing 

consumers’ exposure to false or misleading advertising. 

The practice of advertising prescription drugs to consumers has been 

controversial. The United States is one of only two nations that allow DTC 

advertising (the other is New Zealand). In the United States, there have

been concerns about the impact of DTC advertising on prescription drug 

spending and about potential safety issues, particularly with regard to the 

advertising of new drugs. These concerns have led to calls to restrict DTC 

advertising. For example, the Institute of Medicine recently recommended 

that DTC advertising be restricted during the first two years a new drug is

marketed because some of the health risks of new drugs are not fully 

understood.11

Background 

FDA regulates the content of all prescription drug advertising, whether 

directed to consumers or medical professionals. Advertising that is 

targeted to consumers includes both DTC and “consumer-directed” 

materials. DTC advertising includes, for example, broadcast 

advertisements (such as those on television and radio), print 

advertisements (such as those in magazines and newspapers), and Internet

advertisements (such as consumer advertising on drug companies’ Web 

sites).12 In contrast, consumer-directed advertisements are designed to be

 11Institute of Medicine, The Future of Drug Safety: Promoting and Protecting the Health of

the Public (Washington, D.C.: The National Academies Press, September 2006). 

12A drug company Web site may contain advertising directed to consumers, advertising 

directed to medical professionals, and product labeling. 

Page 8 GAO-07-54 Prescription Drug Advertising
given by medical professionals to consumers and include, for example, 

patient brochures provided in doctors’ offices. 

FDA requires that drug companies submit all final prescription drug 

advertising materials to the agency when they are first disseminated to the 

public.13 Drug companies are generally not required to submit advertising 

materials to FDA before they are disseminated.14 However, drug 

companies sometimes voluntarily submit draft DTC advertising materials 

to FDA in order to obtain advisory comments from the agency.

15

Advertising materials must contain a “true statement” of information 

including a brief summary of side effects, contraindications, and the 

effectiveness of the drug.

16 To meet this requirement, advertising materials 

must not be false or misleading, must present a fair balance of the risks 

and benefits of the drug, and must present any facts that are material to 

the use of the drug or claims made in the advertising. With the exception 

of broadcast advertisements, materials must present all of the risks 

described in the drug’s approved labeling. Broadcast materials may 

present only the major side effects and contraindications, provided the 

 1321 C.F.R. § 314.81(b)(3)(2006).

14See 21 U.S.C. § 352(n)(3)(A) (providing that FDA generally may not require 

advertisements to be submitted for approval prior to dissemination). Advertising and 

promotional materials must be submitted to FDA before they are disseminated for drugs 

approved under FDA’s accelerated approval process, which is for drugs that treat serious

or life-threatening illnesses, and for drugs approved based on animal studies where human 

efficacy studies are not ethical or feasible. 21 C.F.R. §§ 314.550, 314.640(2006). 

15PhRMA issued guidance effective January 2006 that states that “[drug] companies should

submit all new DTC television advertisements to the FDA before releasing these 

advertisements for broadcast.” PhRMA, PhRMA Guiding Principles: Direct to Consumer 

Advertisements about Prescription Medicines (Washington, D.C.: PhRMA, November

2005), http://www.phrma.org/files/DTCGuidingprinciples.pdf (last accessed July 31, 2006). 

1621 C.F.R. § 202.1(e)(1)(2006). Those advertising materials that call attention to the name 

of the drug but do not include indication or dosage recommendations for use of the drug

are exempt from these brief summary requirements. 

Page 9 GAO-07-54 Prescription Drug Advertising
materials make “adequate provision” to give consumers access to the 

information in the drug’s approved or permitted package labeling.17

Within FDA, DDMAC is responsible for implementing the laws and 

regulations that apply to prescription drug advertising. The division, which 

had 41 staff as of July 2006, is responsible for the oversight of both 

advertising directed to consumers and advertising directed to medical 

professionals. In March 2002, DDMAC created a DTC Review Group, 

which is responsible for oversight of advertising materials that are 

directed to consumers. Four Professional Review groups are responsible 

for oversight of promotional materials targeted to medical professionals. 

The DTC Review Group was allocated a group leader, four reviewers, and

two social scientists when it was created. This group’s responsibilities 

include reviewing final DTC materials and reviewing and providing 

advisory comments on draft DTC materials. The group also monitors 

television, magazines, and consumer advertising on drug companies’ Web

sites to identify advertising materials that were not submitted to FDA at 

the time they were first disseminated and reviews advertising materials 

cited in complaints submitted by competitors, consumers, and others. The 

two social scientists support reviewers in both the DTC and professional 

groups in their assessment of the content of advertising materials and 

conduct research related to DTC advertising, such as surveys of consumer 

and physician attitudes toward DTC advertising.

Once submitted to FDA, final and draft DTC advertising materials are 

distributed to a reviewer in the DTC Review Group. For final materials, if 

the reviewer identifies a concern, the agency determines whether it 

represents a violation and merits a regulatory letter. For draft materials 

submitted by drug companies, FDA may provide the drug company with 

advisory comments to consider before the materials are disseminated to 

 17FDA published draft guidance for DTC broadcast advertisements in 1997, and final

guidance in 1999, that described an approach drug companies could use to meet the 

regulatory requirement for making adequate provision of key information. The outlined

approach provides that drug companies disseminate complete information included in a

drug’s approved package labeling through four alternative sources—including a toll-free 

number and a drug company Web site. See FDA, Guidance for Industry: ConsumerDirected Broadcast Advertisements (Rockville, Md.: FDA, August 1999). For other 

guidance related to DTC advertising, see FDA, Draft Guidance for Industry: Brief 

Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements 

(Rockville, Md.: FDA, January 2004), and FDA, Draft Guidance for Industry: Help-Seeking

and Other Disease Awareness Communications by or on Behalf of Drug and Device

Firms (Rockville, Md.: FDA, January 2004).

Page 10 GAO-07-54 Prescription Drug Advertising
consumers if, for example, the reviewers identify claims in materials that 

could violate applicable laws and regulations.18

If FDA identifies violations in disseminated DTC materials, the agency can 

issue two types of regulatory letters—either a “warning letter” or an 

“untitled letter.” Warning letters are typically issued for violations that may 

lead FDA to pursue enforcement action if not corrected; untitled letters 

are issued for violations that do not meet this threshold. FDA generally

posts issued letters on its Web site within several days of issuance.19 Both 

types of letters—which ranged from 2 to 9 pages, from 1997 through 

2005—cite the type of violation identified in the company’s advertising 

material, request that the company submit a written response to FDA 

within 14 days, and request that the company take specific actions. 

Untitled letters request that companies stop disseminating the cited 

advertising materials and other advertising materials with the same or 

similar claims. In addition, warning letters further request that the 

company issue advertising materials to correct the misleading impressions 

left by the violative advertising materials. While FDA does not have 

explicit authority to require companies to act upon these letters, if the 

companies continue to violate applicable laws or regulations, the agency 

has other administrative and judicial enforcement avenues that could 

encourage compliance or result in the product being taken off the market. 

For example, FDA, through the Department of Justice, may seek 

additional remedies in the courts resulting in the seizure of drugs deemed 

to be misbranded because their advertising is false or misleading. 

As reviewers from the DTC Review Group draft the regulatory letters, they 

sometimes obtain consultations from other FDA experts. For example, 

they may consult with the social scientists in the DTC Review Group about 

how consumers might interpret the violative materials, with the regulatory 

counsel in DDMAC about regulatory issues, or with a medical officer in 

FDA’s Office of New Drugs who has knowledge of a drug’s clinical testing 

and approval history. The reviewers may also consult with reviewers in 

DDMAC’s Professional Review groups. 

 18If FDA notifies the drug company that a draft material is not in violation and, at some

subsequent time, changes its opinion, the agency is to notify the drug company in writing 

and is to provide it with a reasonable amount of time for correction before any regulatory

action is taken. 21 C.F.R. § 202.1(j)(4)(2006). 

19FDA, Center for Drug Evaluation and Research, Warning Letters and Notice of Violation 

Letters to Pharmaceutical Companies (Rockville, Md.: FDA, 2006),

http://www.fda.gov/cder/warn/ (last accessed Sept. 26, 2006). 

Page 11 GAO-07-54 Prescription Drug Advertising
The draft regulatory letters are subsequently reviewed by officials in 

DDMAC, FDA’s Office of Medical Policy (which oversees DDMAC), and 

OCC. In January 2002, at the direction of the Deputy Secretary of HHS, 

FDA implemented a policy change requiring OCC to review and approve 

all regulatory letters prior to their issuance, including letters drafted by the 

DTC Review Group, to ensure “legal sufficiency and consistency with 

agency policy.”20 In its written comments on a draft of our 2002 report, 

FDA stated that, prior to the policy change, there had been complaints that 

FDA would not follow up on many of its regulatory letters, and that the 

goal of the policy change was to promote voluntary compliance by 

ensuring that drug companies who receive a regulatory letter understand 

that the letter has undergone legal review and the agency is prepared to go

to court if necessary.21

The amount that drug companies spend on DTC advertising increased 

twice as fast as spending on promotion to physicians or on research and 

development. IMS Health estimated that, from 1997 through 2005, 

spending on DTC advertising in the United States increased from 

$1.1 billion to $4.2 billion—an average annual increase of almost 

20 percent.22 In contrast, over the same time period, IMS Health estimated 

that spending on drug promotion to physicians increased by 9 percent 

annually. Further, PhRMA reported that spending on the research and

development of new drugs increased by about 9 percent annually during 

the same period.23 While spending on DTC advertising has grown rapidly, 

companies continue to spend more on promotion to physicians and on 

research and development. In addition, IMS Health reports that the retail

value of the free drug samples that companies provide to medical 

Drug Company 

Spending on DTC 

Advertising Has 

Increased More 

Rapidly Than 

Spending on 

Promotion to 

Physicians or 

Research and 

Development 

 20Prior to the January 2002 policy change, OCC review and approval of draft regulatory 

letters before their issuance was not required. DDMAC officials told us, however, that prior 

to the policy change they routinely obtained feedback from OCC on draft warning letters. 

21GAO-03-177, p. 32. 

22IMS Health Inc., “Total U.S. Promotional Spend, by Type,” Top-Line Industry Data

(Fairfield, Conn.: IMS Health Inc., 2006), http://www.imshealth.com/ (last accessed Aug. 21, 

2006). 

23PhRMA, Pharmaceutical Industry Profile 2006 (Washington, D.C.: PhRMA, March 2006). 

Page 12 GAO-07-54 Prescription Drug Advertising
professionals to distribute to their patients has increased by about 

15 percent annually.24 (See table 1.) 

Table 1: Prescription Drug Promotion and Research and Development, 1997 through 2005 

Dollars in billions 

1997 1998 1999 2000 2001 2002 2003 2004 2005

Average 

annual 

percentage

increase

Total

percentage

increase, 

1997-2005 

Promotion 

Spending on DTC advertisinga$1.1 $1.3 $1.8 $2.5 $2.7 $2.6 $3.3 $4.0 $4.2 19.6 296.4

Spending on promotion to 

physiciansb

3.9 4.6 4.8 5.6 5.9 6.6 7.4 7.8 7.2 9.0 86.0

Retail value of samplesc6.0 6.6 7.2 8.5 10.5 11.9 13.5 15.9 n.a. 14.9d162.4d

Research and Development 

Spending on research and 

developmente

15.5 17.1 18.5 21.4 23.5 25.7 27.1 29.6 31.4f9.3 103.3

Sources: GAO analysis of IMS Health and PhRMA data. 

Legend: n.a. = not available. 

a

Includes estimated spending on DTC advertising on television, in magazines and newspapers, on 

radio, and outdoors (such as on billboards). The estimates do not include other spending, such as

spending to develop and maintain drug companies’ Web sites or spending on sponsorship of sporting 

events. 

b

Includes estimated spending on office- and hospital-based promotion to physicians and journal 

advertising. These estimates do not include other spending, such as drug company spending on 

meetings and events, or spending on promotion that targets medical professionals other than 

physicians, such as nurse practitioners and physicians assistants. 

c

We used the retail value of drug samples as a measure of the volume of drug samples provided to 

physicians, but the retail value of samples does not directly reflect the amount spent by drug 

companies to manufacture and provide these samples. 

d

Represents data from 1997 through 2004. 

e

Includes spending on research and development reported by PhRMA member companies, as

reported in PhRMA’s annual industry review. Although not all drug companies are members of 

PhRMA, its member companies account for almost all spending on prescription drug promotion. 

f

This figure represents an estimate by PhRMA of spending for this year. 

 24We used the retail value of drug samples as a measure of the volume of drug samples

provided to physicians, but the retail value of samples does not directly reflect the amount

spent by drug companies to manufacture and provide these samples.

Page 13 GAO-07-54 Prescription Drug Advertising
Some types of promotional spending are not captured in the data we 

report. For example, figures for spending on DTC advertising do not 

include spending to develop and maintain drug companies’ Web sites or 

spending on sponsorship of sporting events. In addition, some spending on

promotion to medical professionals is not captured. For example, the data 

do not include drug company spending on meetings and events, or 

spending on promotion that targets medical professionals other than 

physicians, such as nurse practitioners and physicians assistants. 

Drug companies concentrate their spending on DTC advertising in specific 

forms of media and on relatively few drugs. Television and magazine 

advertising represented about 94 percent of all spending on DTC 

advertising in 2005. DTC advertising also tends to be concentrated on 

relatively few brand name prescription drugs—in 2005, the top 20 DTC 

advertised drugs accounted for more than 50 percent of all spending on 

DTC advertising.25 Many of the drugs most heavily advertised to consumers 

in 2005 were for the treatment of chronic conditions, such as high 

cholesterol, asthma, and allergies. Several of the drugs that have high 

levels of DTC advertising are also often promoted to physicians, and the 

drug companies often provide physicians with free samples of these drugs 

to be given to consumers. 

Studies we reviewed suggest that DTC advertising increases prescription 

drug spending and utilization. It increases utilization by prompting some 

consumers to request the drugs from their physicians and for some 

physicians to prescribe the requested drugs. Evidence about increased 

utilization prompted by DTC advertising suggests it can have both positive 

and negative effects on consumers. 

Studies we reviewed suggest that DTC advertising can increase drug 

spending for both the advertised drug and for other drugs that are used to

treat the same condition. Studies have found that, for many drugs, DTC 

advertising increases sales of the drug itself, though the amount varies 

substantially. Across the studies we examined, estimates for certain drugs 

range from little change in sales to an increase of more than $6 for every 

$1 spent to advertise the specific drug. For example, one study of 64 drugs 

found a median increase in sales of $2.20 for every $1 spent on DTC 

Research Suggests 

DTC Advertising 

Increases Drug 

Spending and 

Utilization 

 25Med Ad News staff, “DTC Takes a Back Seat,” Med Ad News, vol. 25, no. 5 (May 2006). 

Page 14 GAO-07-54 Prescription Drug Advertising
advertising.26 The impact of DTC advertising on the sales of an individual 

drug depends on many factors. For example, one study found that, for the 

63 drugs with the largest revenues in 2000, DTC advertising for newer 

drugs—launched in 1998 or 1999—increased sales more than DTC 

advertising for drugs launched from 1994 through 1997.27 Further, research 

suggests that the sales of a specific drug may be affected by DTC 

advertising for other drugs that treat the same condition. For example, one 

study found that every $1,000 spent on advertising for allergy drugs was 

associated with 24 new prescriptions for one specific allergy drug.28

The studies we reviewed also suggest that DTC advertising increases 

prescribing by prompting some consumers to request the drugs from their 

physicians, and that physicians are generally responsive to the patient

requests. Across the consumer and physician surveys that we reviewed,29

about 90 percent of consumers report having seen a DTC advertisement. 

Studies have found that about 30 percent (ranging from 18 to 44 percent) 

 26David Gascoigne and John Busbice for IMS, DTC ROI: The Latest Findings (presented at

the DTC National Conference, Washington, D.C., Apr. 26, 2006). 

27Dick Wittink, Analysis of ROI for Pharmaceutical Promotion (ARPP) (Westfield, N.J.: 

The Association of Medical Publications, Inc., September 2002), 

http://www.rxpromoroi.org/arpp/media/arpp9_18dwittink.ppt (accessed May 19, 2006). 

28Woodie M. Zachry III et al., “Relationship between Direct-to-Consumer Advertising and 

Physician Diagnosing and Prescribing,” American Journal of Health-Systems Pharmacy, 

vol. 59, no. 1 (2002). 

29Because the precise questions each survey asked and the resulting responses varied, we 

present general findings along with the relevant range of responses. The studies surveyed 

U.S. adults, but were not always representative of the general U.S. population. The surveys

of consumer and physician behaviors that we reviewed included Prevention Magazine’s 

Eighth Annual Survey of Consumer Reaction to Direct-to-Consumer Advertising of 

Prescription Medicines (Emmaus, Pa.: Prevention Magazine, 2005); 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 (Rockville, Md.: FDA, Nov. 19, 2004); Barbara Mintzes et al., “How Does 

Direct-to-Consumer Advertising (DTCA) Affect Prescribing? A Survey in Primary Care

Environments with and without Legal DTCA,” Canadian Medical Association Journal, vol.

169, no. 5 (2003); Sharon Allison-Ottey, Karen Ruffin, and Kimberly Allison, “Assessing the 

Impact of Direct-to-Consumer Advertisements on the AA Patient: A Multisite Survey of 

Patients During the Office Visit,” Journal of the National Medical Association, vol. 95, 

no. 2 (2003); Balaji Datti and Mary W. Carter, “The Effect of Direct-to-Consumer 

Advertising on Prescription Drug Use by Older Adults,” Drugs & Aging, vol. 23, no. 1 

(2006); Stephen E. Everett, “Lay Audience Response to Prescription Drug Advertising,” 

Journal of Advertising Research, vol. 31, no. 2 (1991); The NewsHour with Jim 

Lehrer/Kaiser Family Foundation/Harvard School of Public Health, “National Survey on 

Prescription Drugs,” (Menlo Park, Calif.: Kaiser Family Foundation, Sept. 2000), 

http://www.pbs.org/newshour/health/prescriptions/full_survey.pdf (accessed May 25, 2006). 

Page 15 GAO-07-54 Prescription Drug Advertising
of consumers who have seen DTC advertising reported discussing with 

their physician either the condition seen in an advertisement or an 

advertised drug. Of consumers who reported discussing an advertised 

condition or drug, about one quarter (ranging from 7 to 35 percent) 

reported requesting a prescription for the advertised drug. Surveys have

found that of consumers who requested a drug they saw advertised, 

generally more than half (ranging from 21 to 84 percent) reported 

receiving a prescription for the requested drug. The surveys we reviewed 

found that between 2 and 7 percent of consumers who see a DTC 

advertisement requested and ultimately received a prescription for the 

advertised drug. Studies suggest that physicians are generally responsive 

to consumers’ requests, and that decisions to prescribe a drug are 

influenced by a variety of factors in addition to a patient’s medical 

condition. For example, studies have found that advertising in medical 

journals and visits from drug sales representatives may influence 

physician prescribing to a greater degree than DTC advertising. 

Studies about DTC advertising and the increased utilization of prescription 

drugs it can prompt suggest that its effect on consumers can be both 

positive and negative. Some research suggests that DTC advertising can 

have benefits for consumers, such as encouraging them to talk to their 

doctors about previously undiagnosed conditions. For example, one study 

found that DTC advertising is associated with the diagnosis and treatment 

of high cholesterol with prescription drugs.30 Similarly, another study 

found that DTC advertising for antidepressant drugs was associated with 

an increase in the number of people diagnosed with depression and who 

initiated drug therapy, as well as with a small increase in patients who 

received the appropriate duration of therapy.31 In contrast, other research 

suggests that DTC advertising can have negative effects, such as 

encouraging increases in prescriptions for advertised drugs when 

alternatives may be more appropriate. For example, one study found that 

consumers who requested a pain medication as a result of DTC advertising 

were more likely to get the requested drug than a drug more appropriate 

 30Woodie M. Zachry III et al., “Relationship between Direct-to-Consumer Advertising and 

Physician Diagnosing and Prescribing.” 

31Julie M. Donohue et al., “Effects of Pharmaceutical Promotion on Adherence to the 

Treatment Guidelines for Depression,” Medical Care, vol. 42, no. 12 (2004). 

Page 16 GAO-07-54 Prescription Drug Advertising
for those consumers.32 Another study, using actors posing as patients, 

found that 55 percent of those who presented with symptoms of 

adjustment disorder and requested a specific antidepressant received an

antidepressant, even though treatment with drugs may not have been 

appropriate given their symptoms.33

FDA reviews a small portion of the increasingly large number of DTC 

materials it receives. FDA attempts to target available resources by 

focusing its reviews on the DTC advertising materials that have the 

greatest potential to impact public health, but the agency has not 

documented criteria for prioritizing the materials it receives for review. 

FDA officials told us that agency reviewers consider several informal 

criteria when prioritizing the materials. However, FDA does not apply 

these criteria systematically to the materials it receives. Instead, FDA 

relies on each of the reviewers to be aware of the materials the agency has 

received and accurately apply the criteria to determine the specific 

materials to review. Further, the agency does not document if a particular 

DTC material was reviewed. As a result, the agency cannot ensure that it is 

identifying or reviewing the materials that are the highest priority. 

FDA reviews a small portion of the increasingly large number of DTC 

materials submitted to the agency by drug companies. In 2005, FDA 

received 4,600 final DTC materials (excluding Internet materials) and 6,168

final Internet materials.34 FDA also received 4,690 final consumer-directed 

materials—such as brochures given to consumers by medical

professionals. As shown in figure 1, FDA has received a steadily increasing

FDA Reviews a Small 

Portion of DTC 

Materials and Cannot 

Ensure It Is 

Reviewing the 

Highest-Priority 

Materials 

FDA Reviews a Small 

Portion of DTC Advertising 

Materials

 32Michele M. Spence et al. “Direct-to-Consumer Advertising of COX-2 Inhibitors: Effect on 

Appropriateness of Prescribing,” Medical Care Research and Review, vol. 62, no. 5 (2005). 

This study evaluated the appropriateness of a prescription by determining whether it was 

consistent with a patient’s risk of gastrointestinal bleeding, which was assessed according

to three evidence-based risk assessment guidelines.

33Richard L. Kravitz et al., “Influence of Patients’ Requests for Direct-to-Consumer 

Advertised Antidepressants,” Journal of the American Medical Association, vol. 293, 

no. 16 (2005). This study used actors trained to present a standard set of symptoms to 

office-based physicians and to make standard requests for treatment in accordance with 

the established study protocol. 

34We present Internet materials separately from other DTC materials because FDA’s count 

of submitted materials does not distinguish between Internet materials targeted to 

consumers and those targeted to medical professionals. However, FDA officials told us that

most Internet materials, such as drug companies’ Web sites, include both a consumer and a 

professional component. 

Page 17 GAO-07-54 Prescription Drug Advertising
number of final materials from 1999 through 2005. We could not determine 

whether there has been a similar increase in the number of draft DTC 

materials FDA has received because the agency does not track this 

information.35

Figure 1: Number of Final DTC and Consumer-Directed Materials Submitted to FDA,

1999 through 2005

0

4

8

12

16

1999 2000 2001 2002 2003 2004 2005 

Numbers in thousands

Year

Other consumer-directed

Internet (consumer and professional)

DTC (excluding Internet) 

Source: GAO analysis of FDA data.

Notes: We do not include final DTC materials submitted to FDA in 1997 and 1998 because FDA 

changed the way it categorized submitted materials in 1999. We present Internet materials separately 

from DTC materials because FDA’s data do not distinguish between Internet materials that are 

targeted to consumers and those targeted to professionals. However, FDA officials told us that most 

Internet materials contain a consumer component. 

 35FDA tracks the number of submissions of draft DTC materials, rather than the actual 

number of draft materials. These submissions can include both materials directed to 

consumers and materials targeted to medical professionals, and FDA officials estimated 

that each submission could contain as few as 1 or as many as 60 separate draft materials. 

As a result, we were unable to determine the number of draft DTC materials submitted to 

FDA in a given year. 

Page 18 GAO-07-54 Prescription Drug Advertising
FDA officials told us that the agency receives substantially more final and

draft materials than the DTC Review Group can review. The total number 

of final materials has almost doubled since FDA formed its DTC Review 

Group in March 2002. FDA officials told us that the group was not fully 

staffed until September 2003 and that turnover has been a problem, 

temporarily reducing the number of reviewers in the group from four to 

one in late summer 2005. FDA has since filled all of the positions in the 

group and it added a fifth reviewer in September 2006.36 Officials told us 

that it can take 6 months to a year for new reviewers to become fully 

productive. 

FDA officials estimate that reviewers spend the majority of their time 

reviewing and commenting on draft materials. However, we were unable

to determine the number of final or draft materials FDA reviews, because 

FDA does not track this information. In the case of final and draft 

broadcast materials, FDA officials told us that the DTC group reviews all 

of the materials it receives; in 2005, it received 337 final and 146 draft 

broadcast materials. However, FDA does not document whether these or 

other materials it receives have been reviewed. As a result, FDA cannot 

determine how many materials it reviews in a given year. 

FDA Cannot Ensure That 

It Is Reviewing the 

Highest-Priority DTC 

Advertising Materials 

FDA cannot ensure that it is identifying and reviewing the highest-priority 

DTC materials because it does not have documented criteria that it 

systematically uses to select DTC materials for review. FDA officials told 

us that, to target available resources, the agency prioritizes the review of 

the DTC advertising materials that have the greatest potential to impact 

public health. However, FDA has not documented criteria for reviewers in 

the DTC Review Group to consider when prioritizing materials for review. 

Instead, FDA officials identified informal criteria that reviewers use to 

prioritize their reviews. For example, FDA officials told us that the DTC 

Review Group reviews all final and draft broadcast DTC advertising 

materials because they are likely to be disseminated to a large number of 

people. In addition, FDA officials told us that the agency places a high

priority on reviewing other draft materials because they provide the 

agency with an opportunity to identify problems and ask drug companies

 36FDA officials told us that DDMAC has been approved to hire two additional full-time 

employees, whom DDMAC plans to hire for the DTC Review Group. 

Page 19 GAO-07-54 Prescription Drug Advertising
to correct them before the materials are disseminated to consumers.37 In 

addition, FDA officials told us that reviewers consider whether 

• a nonbroadcast material is likely to be widely disseminated to consumers; 

• a drug has been cited in previous regulatory letters; 

• a drug is being advertised to consumers for the first time; 

• a drug is one of several drugs that can be used to treat the same condition, 

which FDA believes increases the likelihood that advertising will use 

comparative claims that may not be supported by available scientific 

evidence; 

• a drug is cited in a complaint submitted by a competitor, consumer, or 

other stakeholder; 

• a drug has had recent labeling changes, such as the addition of new risk 

information; or 

• a drug was approved under FDA’s accelerated approval process. 

FDA officials indicated that the agency does not systematically apply its 

informal criteria to all of the materials that it receives. Specifically, at the 

time FDA receives the materials, the agency does not identify the materials 

that meet its various criteria. FDA officials told us that the agency does 

identify all final and draft broadcast materials that it receives, but does not 

have a system for identifying any other high-priority materials. Absent 

such a system for all materials, FDA relies on each of the reviewers—in 

consultation with other DDMAC officials—to be aware of the materials 

that have been submitted and to accurately apply the criteria to determine 

the specific materials to review. This creates the potential for reviewers to 

miss materials that the agency would consider to be a high priority for 

review. Furthermore, because FDA does not track information on its 

reviews, the agency cannot determine whether a particular material has 

been reviewed. As a result, the agency cannot ensure that it is identifying 

and reviewing the highest-priority materials. 

 37We did not examine the effectiveness of FDA’s review of draft materials in preventing the 

dissemination of violative DTC materials because FDA does not track whether the draft 

materials it reviews are later cited in a regulatory letter. 

Page 20 GAO-07-54 Prescription Drug Advertising
Since the 2002 policy change requiring legal review by OCC of all draft 

regulatory letters, the agency’s process for drafting and issuing letters has 

taken longer and FDA has issued fewer regulatory letters per year. As a 

result of the policy change, draft regulatory letters receive additional 

levels of review and the DTC reviewers who draft the letters must do 

substantially more work to prepare for and respond to comments resulting 

from review by OCC. Since the policy change, FDA has issued fewer 

regulatory letters per year than it did in any year prior to the change. FDA 

officials told us that the agency issues letters for only the violative DTC 

materials that it considers the most serious and most likely to impact 

consumers’ health. 

Since the 2002 policy change requiring legal review of all draft regulatory

letters, FDA’s process for issuing letters has taken longer. Once FDA 

identifies a violation in a DTC advertising material and determines that it 

merits a regulatory letter, FDA takes several months to draft and issue a 

letter.38 (See fig. 2.) For letters issued from 2002 through 2005, once 

DDMAC began drafting a letter for violative DTC materials it took an 

average of about 4 months to issue the letter. The length of this process 

varied substantially across these regulatory letters—one letter took 

around 3 weeks from drafting to issuance, while another took almost 

19 months. In comparison, for regulatory letters issued from 1997 through 

2001, it took an average of 2 weeks from drafting to issuance. During this 

earlier time period, 11 letters were issued the day they were drafted, and 

the longest time from drafting to issuance was slightly more than 

6 months. 

Since the 2002 Policy 

Change, FDA’s 

Process for Issuing 

Regulatory Letters 

Has Taken Longer and 

the Agency Has 

Issued Fewer Letters 

FDA’s Process for Issuing 

Regulatory Letters Has 

Taken Longer Since the 

2002 Policy Change 

 38FDA does not track when it identifies a violation in a DTC material and determines that it 

merits a regulatory letter. Because the agency does, however, document the date on which 

reviewers first began drafting a letter, we examined the amount of time it took for FDA to 

draft and issue a letter. 

Page 21 GAO-07-54 Prescription Drug Advertising
Figure 2: Average Months to Issue Regulatory Letters Citing Violative DTC 

Materials, 1997 through 2005 

Note: For each letter, we determined the number of months from the date on which a reviewer first 

began drafting a regulatory letter to the date the letter was issued. FDA does not track the date a 

violation was identified or the date it was determined that the violation merited a regulatory letter. 

The primary factor contributing to the increase in the length of FDA’s 

process for issuing regulatory letters is the additional work that resulted 

from the 2002 policy change. In addition to the time required of OCC, 

DDMAC officials told us that the policy change has created the need for 

substantially more work on their part to prepare the necessary 

documentation for legal review. According to DDMAC officials, to prepare 

for initial meetings with OCC on draft regulatory letters reviewers prepare 

extensive background information describing the violations as well as the 

drug and its promotional history. As a part of this process, DDMAC 

reviewers sometimes seek consultations with regulatory and clinical 

experts within FDA. For example, reviewers may request consultations 

with the medical officers in FDA’s Office of New Drugs in order to 

determine whether available data from the drug approval process are 

0

1

2

3

4

5

6

1997 1998 1999 2000 2001 2002 2003 2004 2005 

Months to issue regulatory letters (initial draft to issuance)

Year

Source: GAO analysis of FDA documents.

Page 22 GAO-07-54 Prescription Drug Advertising
sufficient to support the advertising claims being made in DTC materials.39

After incorporating comments from the requested consultations, DDMAC 

reviewers hold their initial meeting with OCC and subsequently revise the 

draft regulatory letter to reflect the comments from OCC. Once these 

initial revisions are complete, DDMAC formally submits a draft regulatory

letter to OCC for legal review and approval. All DDMAC regulatory letters 

are reviewed by both OCC staff and OCC’s Chief Counsel. OCC often 

requires additional revisions to the draft regulatory letter before OCC will 

concur that a letter is legally supportable and can be issued. Depending on

comments provided by OCC, the DDMAC reviewers may request 

additional consultations with FDA experts at each stage of review. 

OCC officials told us that the office has given regulatory letters that cite 

violative DTC materials higher priority than other types of regulatory 

letters, but that the attorneys have many other responsibilities. Prior to 

2005, OCC had two staff attorneys and one supervising attorney assigned 

to review all of the regulatory letters submitted by DDMAC, including the 

letters that cite DTC materials. However, OCC officials told us that the 

review of DDMAC’s draft regulatory letters is a small portion of their total 

responsibilities and must be balanced with other requests, such as the 

examination of legal issues surrounding the approval of a new drug. OCC 

officials told us that, in 2005, the office assigned two additional attorneys 

in an attempt to help issue the DDMAC regulatory letters more quickly. 

Prior to September 2005, OCC had a goal of providing initial comments to 

DDMAC within 15 business days from the date that a letter citing DTC 

materials was formally submitted.40 Based on our review of DDMAC’s and 

OCC’s documentation for the 19 letters issued from 2004 through 2005, we 

 39Of the 19 regulatory letters FDA issued from 2004 through 2005, reviewers obtained a 

consultation from the social scientists in the DTC Review Group for 5 letters and from

medical officers in the Office of New Drugs for 9 letters. FDA officials told us that some of

these consultations were due to increasingly complex advertising claims—for example, 

claims that the drug is more effective than other drugs—and DTC advertising for more 

complex drugs—for example, drugs that treat the human immunodeficiency virus or

diabetes. We did not examine the numbers of consultations obtained in prior years because 

FDA officials told us that its documentation of consultations in earlier years was not 

reliable. 

40OCC officials indicated that OCC changed this goal in September 2005 and now has a goal

of providing initial comments to DDMAC within 10 business days from the date that a letter 

is formally submitted. We used the 15-day goal in our analysis because each of the 19 

regulatory letters issued from 2004 through 2005 were submitted to OCC prior to 

September 2005. 

Page 23 GAO-07-54 Prescription Drug Advertising
estimated that OCC generally met its 15-day goal for providing initial 

comments. However, the goal OCC established is not directly relevant to

the total amount of time it takes FDA to issue the regulatory letter once it 

has been formally submitted to OCC because DDMAC must make changes 

to the letters to respond to OCC’s comments and OCC may review letters 

more than once. For regulatory letters issued from 2004 through 2005 that

cited violative DTC materials, we found that, once DDMAC had formally 

submitted a draft letter to OCC, it took an average of about 3 months for 

the letter to receive final OCC concurrence and be issued. FDA does not 

have a goal for how long it should take the agency to issue a letter from 

the time that OCC first formally receives a draft of the letter.41

The number of regulatory letters FDA issued per year for violative DTC 

materials decreased after the 2002 policy change lengthened the agency’s 

process for issuing letters. From 2002 to 2005, the agency issued between 8 

and 11 regulatory letters per year that cited DTC materials.42 (See fig. 3.) 

Prior to the policy change, the agency issued about twice as many such 

regulatory letters per year. From 1997 through 2001, FDA issued between 

15 and 25 letters citing DTC materials per year. An FDA official told us that 

both the lengthened review time resulting from the 2002 policy change and 

staff turnover within the DTC Review Group contributed to the decline in 

the number of issued regulatory letters. In addition, from 2002 through 

2005,

43 FDA did not ultimately issue 10 draft regulatory letters citing DTC 

materials that DDMAC had submitted to OCC for the required legal review. 

For 5 letters, OCC determined that there was insufficient legal support for 

issuing the letters and, therefore, did not concur with DDMAC. DDMAC 

withdrew the other 5 letters from OCC’s consideration but could not 

provide us with information on why it withdrew these letters. 

FDA Issued Fewer 

Regulatory Letters Citing 

Violative DTC Advertising 

Materials after Its 2002 

Policy Change 

 41HHS indicated in its written comments on a draft of our October 2002 report that it had 

“established a goal of issuing regulatory letters within 15 working days of review at OCC” 

(GAO-03-177, p. 33). However, FDA officials have subsequently told us that there is no set 

goal for issuing regulatory letters and, instead, OCC had agreed to provide DDMAC with 

initial comments within 15 business days from the date draft regulatory letters citing DTC 

materials were formally submitted to OCC. 

42From January through September 2006, FDA issued three regulatory letters citing 

violative DTC materials, one of which was a warning letter. 

43FDA officials indicated that OCC began tracking information on its reviews of draft 

regulatory letters in April 2002. 

Page 24 GAO-07-54 Prescription Drug Advertising
Figure 3: Number of Regulatory Letters FDA Issued That Cited DTC Advertising

Materials, 1997 through 2005 

Although the total number of regulatory letters FDA issued for violative 

DTC materials decreased, the agency issued relatively more warning 

letters—which cite violations FDA considers to be more serious—in 

recent years. Historically, almost all of the regulatory letters that FDA 

issued for DTC materials were untitled letters for less serious violations. 

From 1997 through 2001, FDA issued 98 regulatory letters, 6 of which were 

warning letters. From 2002 through 2005, 8 of the 37 regulatory letters 

were warning letters. 

FDA regulatory letters may cite more than one DTC material or type of 

violation for a given drug.

44 Of the 19 regulatory letters FDA issued from 

2004 through 2005, 7 cited more than 1 DTC material, for a total of 31

0

5

10

15

20

25

30

1997 1998 1999 2000 2001 2002 2003 2004 2005

Numbers of letters

Year

Warning letters

Untitled letters

Source: GAO analysis of FDA regulatory letters.

 44Of the 19 regulatory letters issued from 2004 through 2005, 18 cited violative advertising 

materials for only one drug. One letter cited materials for two drugs promoted by a single 

company. 

Page 25 GAO-07-54 Prescription Drug Advertising
different materials.45 These 31 materials appeared in a range of media, 

including television, radio, print, direct mail, and Internet. Further, FDA 

identified multiple violations in 21 of the 31 DTC materials cited in the 

letters. The most commonly cited violations related to a failure of the 

material to accurately communicate information about the safety of the 

drug. For example, FDA wrote in 5 letters that distracting visuals in cited 

television advertisements minimized important information about the risk 

of the drug. The letters also often cited materials for overstating the 

effectiveness of the drug or using misleading comparative claims. 

FDA officials told us that the agency issues regulatory letters for DTC 

materials that it believes are the most likely to negatively impact 

consumers and does not act on all of the concerns that its reviewers 

identify. When reviewers have concerns about DTC materials, they discuss 

them with others in DDMAC and may meet with OCC and medical officers 

in FDA’s Office of New Drugs to determine whether a regulatory letter is 

warranted or on the content of the letter itself. FDA officials told us that 

the agency issues regulatory letters only for the violative materials that it

considers the most likely to negatively impact public health. For example, 

they said the agency may be more likely to issue a letter when a false or 

misleading material was broadly disseminated to a large number of 

consumers. In addition, FDA officials told us that they are more likely to 

issue a regulatory letter when the drug is one of several drugs that can be

used to treat the same condition; they said that the issuance of a 

regulatory letter in this situation may enhance future voluntary 

compliance by promoters of the competing drugs. However, because FDA 

does not document decisions made at the various stages of its review 

process about whether to pursue a violation, officials were unable to 

provide us with an estimate of the number of materials about which 

concerns were raised but the agency did not issue a letter. 

FDA Issues Regulatory 

Letters Only for DTC 

Advertising Materials It 

Considers Most Likely to 

Negatively Impact 

Consumers 

 45Of the 19 regulatory letters citing DTC materials, 2 also cited materials intended to be 

provided to consumers by medical professionals and 5 also cited materials targeted directly 

to medical professionals. 

Page 26 GAO-07-54 Prescription Drug Advertising
FDA regulatory letters have been limited in their effectiveness at halting 

the dissemination of false and misleading DTC advertising materials. We 

found that, from 2004 through 2005, FDA issued regulatory letters an 

average of about 8 months after the violative DTC materials they cited 

were first disseminated. By the time these letters were issued, drug 

companies had already discontinued more than half of the cited materials. 

For the materials that were still being disseminated, drug companies 

removed the cited materials in response to FDA’s letter. Drug companies 

also identified and removed other materials with claims similar to the 

materials cited in the regulatory letters. Although drug companies 

complied with FDA’s requests to create materials that correct the 

misimpressions left by the cited materials, these corrections were not 

disseminated until 5 months or more after FDA issued the regulatory 

letter. Despite halting the dissemination of both cited and other violative 

materials at the time the letter was issued, FDA’s issuance of these letters 

did not always prevent drug companies from later disseminating similar 

violative materials for the same drugs. 

Effectiveness of FDA 

Regulatory Letters at 

Halting Dissemination 

of Violative DTC 

Materials Has Been 

Limited 

Page 27 GAO-07-54 Prescription Drug Advertising
FDA’s regulatory letters have been limited in their effectiveness at halting 

the dissemination of the violative DTC materials they cite. Because of the

length of time it took FDA to issue these letters, violative advertisements 

were often disseminated for several months before the letters were issued. 

From 2004 through 2005, FDA issued regulatory letters citing DTC 

materials an average of about 8 months after the violative materials were 

first disseminated. FDA issued one letter less than 1 month after the 

material was first disseminated, while another letter took over 3 years. The 

cited materials were usually disseminated for 3 or more months, though 

there was substantial variability across materials. Of the 31 violative DTC 

materials cited in these letters, 16 were no longer being disseminated by 

the time the letter was issued. On average, these letters were issued more 

than 4 months after the drug company stopped disseminating these 

materials, and therefore had no impact on their dissemination. For the 14 

DTC materials that were still in use when FDA issued the letter, the drug 

companies complied with FDA’s request to stop disseminating the 

violative materials.46 However, by the time the letters were issued, these 14

materials had been disseminated for an average of about 7 months.47 See 

figure 4 for information on the timeliness of the 19 regulatory letters 

relative to the dissemination of the DTC advertising materials they cited. 

Lack of Timely Issuance of 

Regulatory Letters Limits 

FDA’s Effectiveness at 

Halting Violative DTC 

Advertising Materials 

 46For one violative advertising material, we were unable to determine from FDA’s case files 

when the violative advertising material ended. 

47This average is based on 12 of 14 advertising materials for which we were able to 

determine the length of time the materials were disseminated. 

Page 28 GAO-07-54 Prescription Drug Advertising
Figure 4: Timelines for 19 Regulatory Letters Issued from 2004 through 2005 and the Cited DTC Materials 

Source: GAO analysis of FDA regulatory letters and documentation.

Dissemination of violative material

FDA’s letter drafting period

Initial dissemination of corrective material

Months that the violative material was disseminated,

and FDA’s letter drafting period

Months until the drug company initially disseminated 

the corrective material

0 10

Months before letter issuance Months after letter issuance

#1

#2

#3

#4

#5

#6

#7

#8

#9

#10

#11

#12

#13

#14

#15

#16

#17

#18

#19

FDA letter 

issuance

-15 -5 5 15

b

a

c

b

d

-10 0

Note: Of these 19 regulatory letters, 18 cited violative advertising materials for a single drug. In one 

instance, the letter cited materials promoting two drugs promoted by a single company. 

a

The drug company started disseminating the violative DTC material about 36 months before FDA 

issued the regulatory letter. 

Page 29 GAO-07-54 Prescription Drug Advertising
b

We were unable to determine from FDA’s documentation the date the drug company first 

disseminated the violative material. However, the drug company indicated in correspondence with 

FDA that it stopped disseminating the material when it received the regulatory letter. 

c

The drug company started disseminating the violative material about 31 months before FDA issued

the regulatory letter. 

d

FDA started drafting the regulatory letter about 19 months before the letter was issued. This letter, 

which was drafted about 9 months before the violative DTC material was first disseminated, also cited 

materials directed to medical professionals, and those materials are not represented in this figure. In 

addition, we were unable to determine from FDA’s documentation the date the drug company 

stopped disseminating the violative material. However, the drug company indicated that the material 

was no longer being disseminated when it initially responded to FDA’s regulatory letter. 

As requested by FDA in the regulatory letters, drug companies often 

identified and stopped disseminating other materials with claims similar to 

those in the violative materials. For 18 of the 19 regulatory letters issued 

from 2004 through 2005, the drug companies indicated to FDA that they 

had either identified additional similar materials or that they were 

reviewing all materials to ensure compliance.48 Some of these drug 

companies indicated in their correspondence with FDA which similar 

materials they had identified. Specifically, drug companies responding to 

13 letters indicated that they had identified and stopped disseminating 

between 1 and 27 similar DTC and other materials directed to consumers 

that had not been cited in the regulatory letter. In addition to halting 

materials directed to consumers, companies responding to 11 letters also 

stopped disseminating materials with similar claims that were targeted 

directly to medical professionals.49

Drug companies disseminated the corrective advertising materials 

requested in FDA warning letters, but took 5 months or more to do so. In 

each of the six warning letters FDA issued in 2004 and 2005 that cited DTC 

materials, the agency asked the drug company to disseminate truthful, 

nonmisleading, and complete corrective messages about the issues 

discussed in the regulatory letter to the audiences that received the 

violative promotional materials. In each case, the drug company complied

with this request by disseminating corrective advertising materials. For 

four warning letters we were able to examine the resulting corrective 

FDA Regulatory Letters 

Led Drug Companies to 

Identify and Remove 

Materials Similar to the 

Violative DTC Advertising 

Materials

Drug Companies 

Disseminated Corrective 

Advertising Materials 

5 Months or More after 

FDA Issued the Regulatory 

Letter 

 48For one letter, the FDA documentation we reviewed did not contain the drug company’s 

written response. 

49In their responses, the drug companies identified between 1 and 18 materials directed to 

medical professionals. 

Page 30 GAO-07-54 Prescription Drug Advertising
materials and found that they each contained an explicit reference to the 

regulatory letter and a message intended to correct misleading 

impressions created by the violative claim.50 In addition, the drug 

companies provided evidence to FDA that the materials would be 

disseminated to a consumer population similar to the one that received the 

original violative advertising materials. For example, one drug company 

provided FDA with the broadcast schedule for the violative television 

advertisement and the planned schedule for the corrective advertising 

material to demonstrate that it would run on similar channels, at similar 

times, and with similar frequency. 

For the six warning letters FDA issued in 2004 and 2005 that cited DTC 

materials, the corrective advertising materials were initially disseminated 

more than 5 to almost 12 months after FDA issued the letter. For example, 

for one allergy medication, the violative advertisements ran from April 

through October 2004, FDA issued the regulatory letter in April 2005, and

the corrective advertisement was not issued until January 2006. FDA 

officials told us that the process of issuing a corrective advertisement is 

lengthy because the agency and the drug company negotiate the content

and format of the corrective advertisements. They also said that, in some 

cases, FDA reviewers work closely with the drug company to develop, and 

sometimes suggest specific content for, the corrective advertisement. See 

figure 4 for more detail on the dissemination of the corrective 

advertisements. 

FDA Regulatory Letters Do 

Not Always Prevent 

Subsequent Dissemination 

of Violative DTC Materials 

for the Same Drug 

FDA regulatory letters do not always prevent the same drug companies 

from later disseminating violative DTC materials for the same drug, 

sometimes using the same or similar claims. From 1997 through 2005, FDA 

issued regulatory letters for violative DTC materials used to promote 89 

different drugs.51 Of these 89 drugs, 25 had DTC materials that FDA cited in 

more than one regulatory letter, and one drug had DTC materials cited in

eight regulatory letters. For 15 of the 25 drugs, FDA cited similar broad 

 50For two regulatory letters, the FDA documentation that we reviewed did not contain a 

copy of the corrective material that had been disseminated by the drug company. 

51When multiple drugs contained the same active ingredient, we considered them to be the 

same drug for the purposes of this analysis. For example, we considered the tablet and 

syrup versions of a drug to be a single drug product because they contained the same 

active ingredient. 

Page 31 GAO-07-54 Prescription Drug Advertising
categories of violations in multiple regulatory letters.52 For example, FDA 

issued regulatory letters citing DTC materials for a particular drug in 2000

and again in 2005 for “overstating the effectiveness of the drug.” However, 

the specific claims cited in each of these regulatory letters differed. In 

2000, FDA wrote in its regulatory letter that the “totality of the image, the 

music, and the audio statements” in a television advertisement overstated

the effectiveness of the drug. The 2005 letter stated that a different 

television advertisement overstated effectiveness by suggesting that the

drug was effective for “preventing or modifying the progression of 

arthritis” when the drug was approved for the “relief of the signs and 

symptoms” of arthritis. For 4 of the 15 drugs, FDA cited the same specific

violative claim for the same drug in more than one regulatory letter. (See 

table 2.) For example, in 1999 FDA cited a DTC direct mail piece for failing 

to convey important information about the limitations of the studies used 

to approve the promoted drug. In 2001, FDA cited a DTC broadcast 

advertisement for the same drug for failing to include that same 

information. 

 52We did not examine how many of the drugs that were cited for violative DTC materials

had also been cited for violative materials directed to medical professionals. However,

during our review of the regulatory letters, we noted that some drugs have had both types 

of materials cited, and that FDA sometimes cited the same or similar violative claims in 

both types of materials. In addition, the regulatory letters we reviewed sometimes stated 

that FDA, based on its review of draft versions of advertising materials, had previously 

issued advisory comment letters expressing its concern about drug companies’ use of the

claims cited in the regulatory letter. 

Page 32 GAO-07-54 Prescription Drug Advertising
Table 2: Drugs for Which FDA Cited the Same Specific Violative Claim in More Than One Regulatory Letter 

Material cited in FDA letter Drug product 

(company) Condition First letter Subsequent letter 

Ditropan XL 

(Alza Corporation) 

Overactive 

bladder 

Letter cited a DTC direct mail letter for 

failing to convey that the clinical studies 

were set up to include only patients whom 

the company knows would have improved

symptoms on Ditropan XL because they 

were known to have had improved 

symptoms on oxybutynin, the active 

ingredient in Ditropan XL, or other similar 

medications used to treat overactive 

bladder. (Apr. 2, 1999) 

Letter cited a DTC broadcast 

advertisement and a DTC print 

advertisement for failing to prominently 

disclose important facts—specifically, that 

the clinical trials for Ditropan XL were set 

up to include only patients who were known 

to have had improved symptoms on 

oxybutynin, or other similar medications 

used to treat overactive bladder. 

(July 12, 2001)

Letter cited a DTC direct mail letter for 

failing to disclose that patients randomized 

to the placebo arm experienced a 51% 

reduction in the number of wetting 

accidents. (Apr. 2, 1999) 

Letter cited a DTC print advertisement for 

failing to prominently disclose that patients 

randomized to placebo experienced a 51% 

reduction in the number of wetting 

accidents. (July 12, 2001) 

MUSE 

(VIVUS Inc.) 

Erectile 

dysfunction

Letter cited a DTC print advertisement for 

not providing qualifying information with

sufficient prominence to balance out the 

headline claim “Impotence is Optional.” 

(Feb. 19, 1998)

Letter cited a DTC print advertisement for 

not displaying a qualifying subhead with the 

prominence necessary to provide the 

context needed for the headline “Impotence 

is Optional.” (Apr. 1, 1998) 

Letter cited a DTC print advertisement for 

failing to communicate an important 

material characteristic of the drug because 

FDA considers the term “urethral 

suppository” to be an unfamiliar medical

term for the average consumer that does 

not disclose how the drug is used. 

(Apr. 1, 1998) 

Letter cited a DTC television advertisement 

for failing to adequately disclose how the 

drug is used; FDA’s letter specifically 

references the related citation from its 

April 1, 1998 letter. (May 25, 2004) 

Nolvadex 

(AstraZeneca 

Pharmaceuticals LP) 

Breast cancer Letter cited a DTC direct mail 

advertisement for not providing adequate 

context for a risk reduction claim. Without 

additional context, the use of this claim 

overstates the efficacy of the drug at 

reducing incidence of breast cancer in

women at high risk. (July 20, 2000) 

Letter cited a DTC print advertisement for 

not providing adequate context for a risk 

reduction claim. Without additional context, 

the use of this claim overstates the efficacy 

of the drug at reducing occurrence of new 

cancers. (Dec. 14, 2001) 

Prevacid 

(TAP Pharmaceutical 

Products Inc.) 

Gastroesophageal reflux 

disease 

Letter cited a DTC television advertisement 

for not clearly communicating the 

indication, which implies that the drug may 

be used in a broader range of conditions 

because disclosed limitations to the 

indication are nonprominent, hard to 

comprehend, and displayed against 

distracting visual backgrounds. 

(Mar. 15, 2000) 

Letter cited a DTC television advertisement 

for failing to clearly communicate limitations 

of the approved indication because 

communication of the indication is 

interfered with by competing visual, 

graphic, and auditory distractions that 

combine to interfere with, and undermine, a 

typical consumer’s reading and 

comprehension. (Aug. 2, 2002) 

Source: GAO analysis of FDA regulatory letters. 

Page 33 GAO-07-54 Prescription Drug Advertising
Given substantial increases in drug company spending on DTC advertising 

in recent years, and evidence that DTC advertising can influence 

consumers’ behavior, it is important to develop a full understanding of its

impact on the U.S. health care system. It is also important that FDA 

effectively limit the dissemination of DTC advertising that is false or 

misleading. Because FDA reviews a small portion of the final and draft 

DTC materials that it receives, it is important that the agency have a 

process to identify and review the materials that are the highest priority. 

However, FDA lacks documented criteria for identifying and prioritizing 

DTC materials for review, a process to ensure that criteria are applied 

systematically to all materials received, and a system for tracking whether 

materials have been reviewed. As a result, FDA cannot be assured that the 

highest-priority materials have been identified or reviewed. 

Given the length of time it takes FDA to issue regulatory letters and the 

potential for repeated use of violative claims, we are concerned about 

FDA’s effectiveness at limiting consumers’ exposure to false or misleading 

DTC advertising. In our 2002 report, we recommended that HHS take steps 

to reduce the time that FDA’s DTC draft regulatory letters are under 

review. In its written response to the recommendation in that report, HHS 

agreed that it needs to issue DTC regulatory letters more quickly and 

established a goal of issuing the letters “within 15 working days of review

at OCC.” However, we have now found that it takes FDA months to 

complete the process of drafting and reviewing the letters. As we 

previously recommended, we believe that regulatory letters must be issued 

more quickly. 

To improve FDA’s processes for identifying and reviewing final and draft 

DTC advertising materials, we recommend that the Acting Commissioner 

of the Food and Drug Administration take the following three actions: 

Conclusions 

Recommendations for 

Executive Action 

• document criteria for prioritizing materials that it receives for review, 

• systematically apply its documented criteria to all of the materials it 

receives, and 

• track which materials have been reviewed. 

Page 34 GAO-07-54 Prescription Drug Advertising
HHS reviewed a draft of this report and provided comments, which are 

reprinted in appendix II.

In its comments, HHS generally agreed with our description of FDA’s 

oversight of DTC advertising, but disagreed with our recommendations 

and some aspects of our conclusions. First, HHS disagreed with our 

recommendations that it systematically prioritize and track the DTC 

advertising materials it reviews. HHS stated that DDMAC now reviews all 

of some types of high priority DTC materials, especially final and draft 

broadcast advertisements. HHS also commented that, although DDMAC 

has not documented its selection criteria, those criteria are systematically

applied by its reviewers to determine workload priorities. HHS also noted 

that reviewing each DTC material received according to selection criteria 

and tracking the reviews that DDMAC conducts would require DDMAC’s 

staff to be vastly increased. 

We recognize that, with current staffing, DDMAC’s DTC Review Group 

cannot review in detail the more than 10,000 DTC materials that are 

submitted to the agency each year and that DDMAC now focuses its 

review efforts specifically on broadcast materials and draft materials. 

However, it is because DDMAC’s reviewers are only able to review 

selected materials that we believe it is important for FDA to develop a 

more complete and systematic process for screening the materials the 

agency receives. To do so, the informal criteria that reviewers now 

consider when prioritizing reviews should be formalized to help ensure 

consistent application. Contrary to HHS’s comments, we do not agree that

systematically applying these criteria would require that every DTC 

material be reviewed in detail. Instead, FDA should apply the criteria as a 

screening mechanism to all materials it receives. Furthermore, FDA 

already has most of the information that would be necessary to establish a 

system to screen submitted materials against these criteria. For instance, 

when drug companies submit DTC materials to FDA, the agency records 

information about the drug being advertised and the type of material 

submitted. Additionally, for most of the priority criteria described in our 

report, FDA already has information—such as whether the drug has been

the subject of a previous regulatory letter or a recent label change—

needed to determine how the criteria would apply to materials used to 

promote a given drug. 

Agency Comments 

and Our Evaluation 

Page 35 GAO-07-54 Prescription Drug Advertising
Second, HHS also expressed concern that our draft report criticized the 

agency for the length of time it takes to issue regulatory letters and 

declines in the number of letters issued since the policy change requiring 

review by OCC, without adequately addressing the underlying purpose of 

that review. HHS commented that its policy change has led to more 

defensible regulatory letters and better compliance after issuance. We

agree with HHS that it is important to ensure that FDA’s regulatory letters 

are legally supportable, and, as HHS noted, we did not examine the effect

of the policy change on the legal sufficiency of the letters in this report. 

However, we also believe that it is important for letters to be issued in a

timely manner if they are to have an impact on halting the dissemination of 

the violative materials that the letters cite. In 2002, HHS agreed with the 

recommendation of our earlier report that DTC regulatory letters be issued 

more quickly. Nonetheless, as we noted in the draft of this report, we 

found that violative advertisements had often been disseminated for 

several months before letters were issued in 2004 and 2005. More than half

of the violative DTC materials cited in the 2004 and 2005 letters were no 

longer being disseminated by the time the letter was issued. Delays in 

issuing regulatory letters limit FDA’s effectiveness in overseeing DTC 

advertising and in reducing consumers’ exposure to false or misleading 

advertising.

Finally, HHS commented that our discussion of research on DTC 

advertising implies that we statistically aggregated data from different 

studies to generate summary figures on the impact of DTC advertising on 

various types of consumer requests to their physicians. We have revised 

the report to clarify that the information we present is from the studies we 

reviewed and that we did not aggregate data across studies. HHS also 

provided technical comments which we incorporated as appropriate. 

As agreed with your offices, unless you publicly announce the contents of

this report earlier, we plan no further distribution of it until 30 days from 

the date of this letter. We will then send copies of this report to the 

Secretary of Health and Human Services, the Acting Commissioner of the

Food and Drug Administration, and other interested parties. We will also 

make copies available to others who request them. In addition, the report 

will be available at no charge on GAO’s Web site at http://www.gao.gov. 

Page 36 GAO-07-54 Prescription Drug Advertising
If you or your staffs have any questions about this report, please contact 

me at (202) 512-7119 or crossem@gao.gov. Contact points for our Offices 

of Congressional Relations and Public Affairs may be found on the last 

page of this report. GAO staff who made major contributions to this report 

are listed in appendix III. 

Marcia Crosse 

Director, Health Care 

Page 37 GAO-07-54 Prescription Drug Advertising
Appendix I: Scope and Methodology Appendix I: Scope and Methodology 

To examine trends in pharmaceutical industry spending on direct-toconsumer (DTC) advertising, promotion to medical professionals, and 

research and development of new drugs, we reviewed publicly reported 

data. For overall drug company spending from 1997 through 2005 on DTC 

advertising and promotion to medical professionals, we obtained data

from IMS Health.1

 We interviewed knowledgeable IMS Health officials to 

verify the data’s accuracy and the methodologies used for collecting them 

and reviewed related documentation and determined that the data were 

sufficiently reliable for the purposes of this report. In addition, we 

obtained data on drug company spending from 1997 through 2005 on 

research and development of new drugs from the Pharmaceutical 

Research and Manufacturers of America (PhRMA), which represents U.S. 

pharmaceutical research and biotechnology companies. For 2005, we 

reviewed more detailed data on DTC advertising by prescription drug from 

Neilsen Monitor-Plus, which were reported in the May 2006 edition of Med 

Ad News, a publication targeted to the pharmaceutical industry. For the 

PhRMA and Neilsen Monitor-Plus data, we reviewed related

documentation and determined that the data were sufficiently reliable for 

the purposes of this report. The scope of our analysis focuses on trends 

since 1997 because in that year the Food and Drug Administration (FDA) 

issued its draft guidance clarifying the requirements for broadcast 

advertising.

To examine the relationship between DTC advertising and prescription 

drug spending and utilization, we conducted a literature review. We 

conducted a structured search of 33 databases that included peerreviewed journal articles, dissertations, and industry articles issued from 

January 2000 through February 2006. We searched these databases for 

articles with key words in their title or abstract related to DTC advertising, 

such as various versions of the word “advertising,” “consumer,” “patient,” 

“physician,” “doctor,” and “return on investment.” We supplemented this 

list with searches of the references in articles identified through the 

database search. We also included articles cited during our interviews with 

representatives from advocacy organizations—Consumers Union and 

Public Citizen—and industry representatives from PhRMA, AstraZeneca

Pharmaceuticals LP, and Pfizer Inc. From all of these sources, we 

 1

IMS Health data for spending on DTC advertising do not include spending to develop and

maintain drug companies’ Web sites or spending on sponsorship of sporting events. In

addition, the data for spending on promotion to medical professionals do not include drug 

company spending on meetings and events, or spending on promotion that targets medical 

professionals other than physicians, such as nurse practitioners and physicians assistants. 

Page 38 GAO-07-54 Prescription Drug Advertising
Appendix I: Scope and Methodology 

identified over 600 articles published from 1982 through 2006. Within the 

more than 600 articles, we identified for detailed review 64 journal articles 

and dissertations that were original research and had subject matter 

directly relevant to the relationship between DTC advertising and 

prescription drug spending and utilization. 

To examine the DTC advertising materials that FDA reviews, we reviewed 

applicable laws and regulations and data from FDA on the number and 

type of advertising materials that the agency receives and reviews. For 

materials submitted from 1997 through 2005, we obtained data from FDA’s 

Advertising Management Information System database, which tracks the 

number of final advertising materials the drug companies submit to FDA at 

the time of their dissemination to the public. FDA officials told us that 

these data may contain errors because drug companies do not always 

properly identify the type of advertising material in their submission to 

FDA. For example, a DTC material may be incorrectly coded as a material 

directed to professionals. Although FDA officials do not know the extent

to which such errors are entered into the database, based on our review of 

their data collection methods and our interviews with knowledgeable

agency officials, we determined that these data were sufficiently reliable

for reporting on trends in the volume of materials submitted to FDA. We 

also obtained data from FDA’s Marketing, Advertising, and 

Communications Management Information System database—which 

tracks correspondence between the agency and drug companies—to 

determine the number of submissions of draft materials received by FDA 

from 1997 through 2005. We discussed these data with the responsible 

FDA official, and determined that they were sufficiently reliable for their 

use in this report. We also interviewed FDA officials, including staff who 

are directly responsible for reviewing DTC materials, about their 

processes for reviewing advertising materials. We did not examine the 

effectiveness of FDA’s review of draft materials at preventing potentially

violative materials from being disseminated. 

To examine the number of FDA regulatory letters that cited DTC materials 

and FDA’s process for issuing regulatory letters, we reviewed all letters 

issued by FDA from 1997 through 2005 citing prescription drug promotion 

and identified those that cited DTC advertising materials. We excluded

regulatory letters that cited only materials intended to be given to 

consumers by medical professionals or that cited only materials directed 

to medical professionals. We then asked FDA officials to review our list 

and add letters we had not identified and remove letters that did not 

specifically cite DTC materials. As a result of this process, we identified 

135 regulatory letters—citing materials promoting 89 different drugs—that 

Page 39 GAO-07-54 Prescription Drug Advertising
Appendix I: Scope and Methodology 

cited a violative DTC material. In our review of the regulatory letters, we 

did not evaluate the appropriateness of the cited violations or evaluate the

legal sufficiency of the letters. We examined the content of FDA’s most 

recent regulatory letters—the 19 regulatory letters, 6 warning letters and

13 untitled letters, FDA issued from 2004 through 2005—in order to 

determine the types of violations that FDA identified and the actions that 

the agency requested the drug companies to take. (See table 3.) Of these 

19 regulatory letters, 18 cited violative materials for a single drug. In one 

instance, the letter cited materials promoting two drugs promoted by a 

single company. 

Table 3: FDA Regulatory Letters Issued from 2004 through 2005 That Cited DTC Materials 

Drug cited Date of letter

a

Condition Drug company

Type of each cited

advertisement

2004 

Warning letters 

MUSE 5/25/2004 Erectile dysfunction VIVUS Inc. Television

Web site

Norvir 6/10/2004 Human immunodeficiency virus Abbott Laboratories Web site 

Pamine 11/9/2004 Peptic ulcer Bradley Pharmaceuticals Inc. Web site 

Untitled letters 

Crestor 12/21/2004 Cholesterol AstraZeneca

Pharmaceuticals LP 

Print 

Effexor 3/18/2004 Depression Wyeth Pharmaceuticals Radio 

Kaletra 10/29/2004 Human immunodeficiency virus Abbott Laboratories Print 

Restroom poster

Paxil CR 6/9/2004 Social anxiety disorder GlaxoSmithKline Television

Seasonale 12/29/2004 Contraceptive Barr Research Inc. Television

Viagra 11/10/2004 Erectile dysfunction Pfizer Inc. Television 1 

Television 2

Viramune 9/22/2004 Human immunodeficiency virus Boehringer Ingelheim 

Pharmaceuticals Inc. 

Print 

Zyrtec-D 12hr 4/22/2004 Allergies Pfizer Inc. Web site 

2005 

Warning letters 

Enbrel 2/18/2005 Plaque psoriasis Amgen Inc Television

Quadramet 7/18/2005 Pain associated with cancer Cytogen Corporation Radio 

Web site

Page 40 GAO-07-54 Prescription Drug Advertising
Appendix I: Scope and Methodology 

Drug cited Date of letter

a

Condition Drug company

Type of each cited

advertisement

Zyrtec 4/13/2005 Allergies Pfizer Inc. Print 1 

Print 2

Print 3

Untitled letters 

Celebrex and Pfizer Inc. Television 1 

Bextra 

1/10/2005 Osteoarthritis, rheumatoid arthritis, 

painful menstruation Television 2

Television 3

Direct mail

Crestor 3/8/2005 Cholesterol AstraZeneca Television 

Pharmaceuticals LP Print 1 

Print 2

Print 3

Levitra 4/13/2005 Erectile dysfunction Bayer Pharmaceuticals

Corporation 

Television 

Strattera 6/14/2005 Attention deficit hyperactivity 

disorder 

Eli Lilly and Company Television 

Zoloft 5/6/2005 Major depressive disorder Pfizer Inc. Print 

Source: GAO analysis of FDA regulatory letters. 

a

Regulatory letters are available online from FDA, Center for Drug Evaluation and Research, Warning 

Letters and Notice of Violation Letters to Pharmaceutical Companies, http://www.fda.gov/cder/warn/ 

(last accessed on Sept. 26, 2006). 

We also reviewed FDA documentation to determine how long it took the 

agency to draft and issue the 135 regulatory letters it issued from January 

1997 through December 2005. We used information from FDA records to 

obtain the date on which reviewers first began drafting a regulatory letter. 

These records also contained information about key meetings that 

occurred, internal consultations requested by FDA’s Division of Drug 

Marketing, Advertising, and Communications (DDMAC), and the 

comments obtained during the drafting and review of each regulatory 

letter. Because FDA does not track when the agency identifies a violation,

we considered the date on which reviewers first began drafting a 

regulatory letter as the earliest date in the letter drafting and review 

process. For each of the 19 regulatory letters issued from 2004 through 

2005, we obtained the date DDMAC formally submitted the draft letter to 

the Office of the Chief Counsel (OCC) from FDA’s Agency Information 

Management System database. This system is designed to document the 

dates of key interactions between OCC and other FDA offices. OCC 

officials told us that the date DDMAC submitted draft regulatory letters to 

OCC was consistently documented in the system. Based on our 

Page 41 GAO-07-54 Prescription Drug Advertising
Appendix I: Scope and Methodology 

discussions with OCC officials and our review of similar dates recorded in 

DDMAC’s case files, we determined that these data were sufficiently 

reliable for the purposes of this report. 

To examine the effectiveness of FDA’s regulatory letters, we focused on 

the 19 regulatory letters issued from 2004 through 2005 that cited DTC 

materials. We reviewed the files that FDA maintains for each advertised 

drug cited in these letters. These files contain correspondence from the 

drug companies, copies of advertising materials, and documentation of 

FDA actions. We reviewed FDA’s correspondence with the drug 

companies to obtain information regarding the regulatory letters, the dates 

the violative advertisements started and ended, and the drug companies’ 

compliance with any corrective action requested by FDA. The information 

we collected is based both on what drug companies reported in

correspondence with FDA and, in some cases, what we obtained directly 

from the sponsoring drug company. We did not confirm the accuracy of 

the information drug companies reported to FDA or to us. We also 

identified the violations cited in the 135 regulatory letters FDA issued from 

1997 through 2005. 

We conducted our work from January 2006 through November 2006 in

accordance with generally accepted government auditing standards. 

Page 42 GAO-07-54 Prescription Drug Advertising
Appendix II: Comments from the Department Appendix II: Comments from the Department of Health and Human Services 

of Health and Human Services 

Page 43 GAO-07-54 Prescription Drug Advertising
Appendix II: Comments from the Department 

of Health and Human Services 

Page 44 GAO-07-54 Prescription Drug Advertising
Appendix II: Comments from the Department 

of Health and Human Services 

Page 45 GAO-07-54 Prescription Drug Advertising
Appendix II: Comments from the Department 

of Health and Human Services 

Page 46 GAO-07-54 Prescription Drug Advertising
Appendix III: GAO Contact and Staff Acknowledgments 

Page 47 GAO-07-54 

Appendix III: GAO Contact and Staff 

Acknowledgments 

GAO Contact Marcia Crosse, (202) 512-7119 or crossem@gao.gov 

In addition to the contact named above, Martin T. Gahart, Assistant 

Director; Chad Davenport; William Hadley; Cathy Hamann; Julian Klazkin; 

and Eden Savino made key contributions to this report. 

Prescription Drug Advertising

Acknowledgments 

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