United States Government Accountability Office

GAO Testimony 

Before the Subcommittee on Oversight 

and Investigations, Committee on Energy 

and Commerce, House of Representatives

PRESCRIPTION DRUGS

Trends in FDA’s Oversight 

of Direct-to-Consumer 

Advertising 

Statement of Marcia Crosse 

Director, Health Care 

For Release on Delivery

Expected at 10:00 a.m. EDT 

Thursday, May 8, 2008

 

GAO-08-758T 
What GAO Found

United States Government Accountability Office

Why GAO Did This Study

Highlights

Accountability Integrity Reliability

May 8, 2008

PRESCRIPTION DRUGS

Trends in FDA’s Oversight of Direct-to-Consumer 

Advertising

Highlights of GAO-08-758T, a testimony 

before the Subcommittee on Oversight 

and Investigations, Committee on Energy 

and Commerce, House of Representatives

The Food and Drug Administration 

(FDA) is responsible for overseeing

direct-to-consumer (DTC) 

advertising of prescription drugs, 

which includes a range of media, 

such as television, magazines, and 

the Internet. 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. In 2002, GAO

reported on delays in FDA’s 

issuance of regulatory letters. 

GAO was asked to discuss trends in

FDA’s oversight of DTC advertising 

and the actions FDA has taken 

when it identifies violations. This 

statement is based on GAO’s 2006

report, Prescription Drugs:

Improvements Needed in FDA’s 

Oversight of Direct-to-Consumer 

Advertising, GAO-07-54

(November 16, 2006). In this 

statement, GAO discusses the 

(1) DTC advertising materials FDA 

reviews, (2) FDA’s process for 

issuing regulatory letters citing 

DTC advertising materials and the 

number of letters issued, and 

(3) the effectiveness of FDA’s 

regulatory letters at limiting the

dissemination of false or 

misleading DTC advertising. 

For its 2006 report, GAO examined

FDA data on the advertising 

materials the agency received and 

reviewed the regulatory letters it

issued citing prescription drug 

promotion from 1997 through 2005. 

For this statement, GAO also 

reviewed data from FDA to update 

selected information from the 2006

report. 

Since 1999, FDA has received a steadily increasing number of advertising 

materials directed to consumers. In 2006, GAO found that FDA reviewed a 

small portion of the DTC materials it received, and the agency could not 

ensure that it was identifying for review the materials it considered to be 

highest priority. While FDA officials told GAO that the agency prioritized the 

review of materials that had the greatest potential to negatively affect public 

health, the agency had not documented criteria to make this prioritization. 

GAO recommended that FDA document and systematically apply criteria for 

prioritizing its reviews of DTC advertising materials. In May 2008, FDA 

indicated that it had documented criteria to prioritize reviews. However, FDA

still does not systematically apply its criteria to all of the DTC materials it 

receives. Furthermore, GAO noted in its 2006 report that FDA could not 

determine whether a particular material had been reviewed. GAO 

recommended in that report that the agency track which DTC materials had 

been reviewed. FDA officials indicated to GAO in May 2008 that the agency

still did not track this information. As a result, the agency cannot ensure that 

it is identifying and reviewing the highest-priority materials.

GAO found in 2006 that, since a 2002 policy change requiring legal review of 

all draft regulatory letters, FDA’s process for drafting and issuing letters was 

taking longer and the agency was issuing fewer letters per year. FDA officials 

told GAO that the policy change contributed to the lengthened review. 

In 2006, GAO found that the effectiveness of FDA’s regulatory letters at 

halting the dissemination of violative DTC materials had been limited. By the 

time the agency issued regulatory letters, drug companies had already 

discontinued use of more than half of the violative advertising materials 

identified in each letter. In addition, FDA’s issuance of regulatory letters had

not always prevented drug companies from later disseminating similar 

violative materials for the same drugs. 

Number of Materials Directed to Consumers Submitted to FDA, 1999 through 2007 

0

5

10

15

20

25

1999 2000 2001 2002 2003 2004 2005 2006 2007

Numbers in thousands

Source: GAO analysis of FDA data.

Year

Note: Totals include final DTC materials, Internet materials—some of which may be directed to

medical professionals—and materials designed to be given to consumers by medical professionals. 

To view the full product, including the scope 

and methodology, click on GAO-08-758T. 

For more information, contact Marcia Crosse, 

(202) 512-7114, crossem@gao.gov. 
Mr. Chairman and Members of the Subcommittee: 

I am pleased to be here today as you examine the practice of direct-toconsumer (DTC) advertising of prescription drugs, which includes a range 

of media, such as television, magazines, and the Internet. The Department 

of Health and Human Services’ (HHS) Food and Drug Administration 

(FDA) regulates the promotion and advertising of prescription drugs, 

including DTC materials, to ensure they are not false or misleading and 

otherwise comply with applicable laws and regulations. This oversight 

function is carried out by FDA’s Division of Drug Marketing, Advertising, 

and Communications (DDMAC). Recently, you have raised concerns 

regarding potentially misleading DTC advertising for several drugs. 

FDA regulations require that drug companies submit final DTC advertising 

materials to FDA at the time they are first disseminated to the public.1

 In 

addition, although generally not required to do so, drug companies may 

voluntarily submit draft versions of DTC advertising materials to FDA for 

advisory comments.2,3

 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. DDMAC drafts these regulatory letters, which 

are then reviewed and approved by the agency’s Office of Chief Counsel 

(OCC). In October 2002, we reported on delays in FDA’s issuance of these 

regulatory letters and recommended that the agency take action to reduce 

the amount of time for internal review of draft regulatory letters citing 

 1

21 C.F.R. § 314.81(b)(3)(i)(2007). 

2

21 C.F.R. § 202.1(j)(4)(2007). The FDA Amendments Act of 2007 provided FDA with new 

authorities related to the oversight of DTC advertising. The Act, among other things,

authorizes FDA to require the submission of any draft television drug advertisement for 

review up to 45 days before it is scheduled to be disseminated. See Pub. L. No. 110-85, 

§ 901(d)(2), 121 Stat. 823, 939 (2007), codified at 21 U.S.C. § 353b. 

3

The Pharmaceutical Research and Manufacturers of America (PhRMA) issued guidance 

effective January 2006 that states that “[drug] companies should submit all new DTC 

television drug advertisements to the FDA before releasing these advertisements for

broadcast.” PhRMA Guiding Principles: Direct to Consumer Advertisements about 

Prescription Medicines (Washington, D.C.: PhRMA, November 2005), 

http://www.phrma.org/files/DTCGuidingprinciples.pdf (accessed Apr. 29, 2008).

Page 1 GAO-08-758T
violations in DTC materials.4

 In response to our recommendation, FDA 

agreed to take steps to reduce the time to issue regulatory letters. 

My remarks today are primarily based on our November 2006 report on 

trends in FDA’s oversight of DTC advertising and the actions it took when 

it identified a violation in a disseminated DTC advertisement.5

 Today, I will

discuss (1) the DTC advertising materials FDA reviews, (2) FDA’s process 

for issuing regulatory letters citing DTC advertising materials and the 

number of letters issued, and (3) the effectiveness of FDA’s regulatory 

letters at limiting the dissemination of false or misleading DTC advertising.

For our November 2006 report, to examine the DTC advertising materials 

that FDA reviewed, we obtained data from FDA on the number and type of 

advertising materials that it received and reviewed from 1997 through 

2005. To examine FDA’s process for issuing regulatory letters that cited 

violative DTC advertising materials and the number of such letters that 

FDA issued, we reviewed all regulatory letters issued by FDA from 1997 

through 2005. To examine the effectiveness of these regulatory letters, we 

reviewed their content to identify violations cited; we did not evaluate the 

appropriateness or legal sufficiency of these letters. In addition, we 

obtained information from FDA about the timeliness of the letters issued 

in 2004 and 2005 and drug companies’ compliance with any corrective 

action requested by FDA. For this statement, we reviewed data from FDA 

to update selected information from our 2006 report. We shared the 

updated facts contained in this statement with FDA officials. They 

provided technical comments which we incorporated as appropriate. We

conducted the work for our November report from January 2006 through

November 2006 and for this statement from April 2008 through May 2008. 

We conducted all of our work in accordance with generally accepted

government auditing standards. Those standards require that we plan and

perform the audit to obtain sufficient, appropriate evidence to provide a 

reasonable basis for our findings and conclusions based on our audit 

objectives. We believe that the evidence obtained provides a reasonable

basis for our findings and conclusions based on our audit objectives. 

 4

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

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

5

GAO, Prescription Drugs: Improvements Needed in FDA’s Oversight of Direct-toConsumer Advertising, GAO-07-54 (Washington, D.C.: Nov. 16, 2006). 

Page 2 GAO-08-758T
In summary, in our 2006 report we found that FDA reviewed a small 

portion of the DTC materials it received, and the agency could not ensure 

that it identified for review the materials it considered to be highest 

priority. We found that the number of final DTC materials FDA received

each year had almost doubled from 2002 through 2005. Since 2006, the 

number of materials received by FDA has continued to increase. While

FDA officials told us that the agency prioritized the review of materials 

that had the greatest potential to negatively affect public health, we found 

that the agency had not documented criteria to make this prioritization. 

Rather, FDA officials identified informal criteria that reviewers considered 

when identifying materials for review. We recommended that FDA 

document and systematically apply criteria for prioritizing its reviews of 

DTC advertising materials. We also noted in our 2006 report that FDA 

could not determine whether a particular material had been reviewed. 

Therefore, we recommended in our 2006 report that the agency track 

which DTC materials have been reviewed. In May 2008, FDA informed us 

that it now had documented criteria to prioritize reviews. However, FDA 

still does not systematically apply its criteria to all of the DTC materials it 

receives to determine which are highest priority for review. FDA officials 

also indicated to us in May 2008 that the agency still does not track 

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 a 2002 policy change requiring internal legal review of all draft 

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

longer and the agency issued fewer letters per year. Prior to this policy 

change, from 1997 through 2001, it took FDA an average of 2 weeks to 

issue a letter. After the change, 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. In 2006 and 2007, the time 

increased to an average of over 5 months. 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. After the policy change, FDA issued 

about half as many regulatory letters that cited 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 issued 4 such letters in 2006 and 2 in 2007. FDA officials told us

that the agency issued letters only for the violative DTC materials that it 

considered the most serious and most likely to negatively affect 

consumers’ health. 

Page 3 GAO-08-758T
At the time of our 2006 report, we found that the effectiveness of FDA’s 

regulatory letters at halting the dissemination of violative DTC materials 

had been limited. FDA issued 19 such regulatory letters from 2004 through 

2005. On average, it issued these letters 8 months after the violative 

materials were first disseminated. By the time these regulatory letters 

were issued, drug companies had already discontinued more than half of 

the violative advertisements. Generally, companies complied with FDA 

requests to remove cited materials that were still being disseminated, and 

those companies requested to issue corrective materials did so, but not 

until 5 months or more after the regulatory letter was issued. FDA’s 

issuance of regulatory letters did not always prevent 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. Delays in 

issuing regulatory letters limit FDA’s effectiveness in overseeing DTC 

advertising and in reducing consumers’ exposure to false and misleading 

advertising.

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

given by medical professionals to consumers and include, for example, 

patient brochures provided in doctors’ offices. 

Background 

Advertising materials must contain a “true statement” of information 

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

effectiveness of the drug.

6

 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 

 6

21 C.F.R. § 202.1(e)(1),(2)(2007). 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 4 GAO-08-758T
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 

materials make “adequate provision” to give consumers access to the 

information in the drug’s approved or permitted package labeling.7

Within FDA, DDMAC is responsible for implementing the laws and 

regulations that apply to prescription drug advertising. In March 2002, 

DDMAC created a DTC Review Group, which is responsible for oversight 

of advertising materials that are directed to consumers. As of May 2008, 

the group had a total of two group leaders, seven reviewers, and two social 

scientists. 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. 

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

distributed to a DTC reviewer. 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 consumers if, for 

example, the reviewers identify claims in materials that could violate

applicable laws and regulations. 

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

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 additional enforcement actions if not corrected; 

untitled letters are issued for violations that do not meet this threshold. 

Both types of letters cite the type of violation identified in the company’s 

 7

FDA 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 alternative sources, such as a toll-free number 

and a drug company Web site. See FDA, Guidance for Industry: Consumer-Directed

Broadcast Advertisements (Rockville, Md.: Aug. 1999).

Page 5 GAO-08-758T
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. Warning letters further request that the company issue 

advertising materials to correct the misleading impressions left by the

violative advertising materials.8

 The draft regulatory letters are 

subsequently reviewed by officials in DDMAC, FDA’s Office of Medical 

Policy (which oversees DDMAC), and OCC. FDA has stated that it 

instituted OCC review for the purpose of promoting voluntary compliance 

by ensuring that drug companies that receive a regulatory letter 

understand that the letter has undergone legal review and the agency is 

prepared to go to court if necessary.9

As of 2006, FDA reviewed a small portion of the increasingly large number 

of DTC materials it received. FDA attempted to target available resources 

by focusing its reviews on the DTC advertising materials that had the 

greatest potential to negatively affect public health, but the agency did not 

document criteria for prioritizing the materials it received for review. 

Agency reviewers considered several informal criteria when prioritizing 

the materials, but these were not systematically applied and the agency did 

not document if a particular DTC material was reviewed. As a result, the 

agency could not ensure that it was identifying or reviewing the materials 

that were the highest priority. 

FDA Reviewed a 

Small Portion of DTC 

Materials and Could 

Not Ensure It Was 

Reviewing the 

Highest-Priority 

Materials 

FDA officials told us at the time of our 2006 report that the agency 

received substantially more final and draft materials than the DTC Review 

Group could review. In 2005, FDA received 4,600 final DTC materials 

 8

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. With the enactment of 

the FDA Amendments Act of 2007, FDA was also authorized to assess civil monetary

penalties. Pub. L. No. 110-85, § 901(d)(4), 121 Stat. 823, 940-942 (2007), codified at 21 U.S.C. 

§ 333(g). 

9

See GAO-03-177, 32. 

Page 6 GAO-08-758T
(excluding Internet materials) and 6,168 final Internet materials.10 FDA 

also received 4,690 final consumer-directed materials—such as brochures 

given to consumers by medical professionals. FDA received a steadily 

increasing number of final materials from 1999 through 2005. We found 

that, in 2006 and 2007, the total number of final DTC, Internet, and 

consumer-directed materials FDA received continued to increase.11 (See 

fig. 1.) 

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

Submitted to FDA, 1999 through 2007 

0

5

10

15

20

25

1999 2000 2001 2002 2003 2004 2005 2006 2007

Numbers in thousands

Source: GAO analysis of FDA data.

Year

 10FDA’s count of submitted materials did 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. 

11We could not determine whether there had been a similar increase in the number of draft

DTC materials FDA received because the agency did not track this information. 

Page 7 GAO-08-758T
FDA officials estimated that reviewers spent 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 reviewed, because 

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

materials, FDA officials told us that the DTC group reviewed all of the 

materials it received; in 2005, it received 337 final and 146 draft broadcast 

materials. However, FDA did not document whether these or other 

materials it received had been reviewed. As a result, FDA could not 

determine how many materials it reviewed in a given year. We

recommended in our 2006 report that the agency track which DTC 

materials had been reviewed. FDA officials indicated to us in May 2008

that the agency still did not track this information. 

At the time of our 2006 report, FDA officials identified informal criteria 

that the agency used to prioritize its reviews. FDA officials told us that, to

target available resources, the agency prioritized the review of the DTC 

advertising materials that had the greatest potential to negatively affect 

public health. We recommended that FDA document its criteria for 

prioritizing its reviews of DTC advertising materials. FDA informed us in 

May 2008 that it now has documented criteria to prioritize reviews. For 

example, its first priority is to review materials with “egregious” violations, 

such as those identified through complaints. In addition, FDA places a 

high priority on reviewing television advertising materials. FDA officials 

also told us that the agency places a high priority on reviewing draft 

materials because they provide the agency with an opportunity to identify

problems and ask drug companies to correct them before the materials are 

disseminated to consumers. 

We reported in 2006 that FDA did not systematically apply its criteria for 

prioritizing reviews to all of the materials that it received. Specifically, we 

found in 2006 that, at the time FDA received the materials, it recorded 

information about the drug being advertised and the type of material being 

submitted but did not screen the DTC materials to identify those that met 

its various informal criteria. FDA officials told us that the agency did

identify all final and draft broadcast materials that it received, but it did 

not have a system for identifying any other high-priority materials. Absent 

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

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

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

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

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

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

reviews, the agency could not determine whether a particular material had 

Page 8 GAO-08-758T
been reviewed. As a result, the agency could not ensure that it identified 

and reviewed the highest-priority materials. We recommended that the 

agency systematically screen the DTC materials it received against its 

criteria to identify those that are the highest priority for review. As of May 

2008, FDA still did not have such a process. 

In 2006 we reported that, after the 2002 policy change requiring legal 

review by OCC of all draft regulatory letters, the agency’s process for 

drafting and issuing letters citing violative DTC materials had stretched to 

several months and FDA had issued fewer regulatory letters per year. As a

result of the policy change, draft regulatory letters received additional 

levels of review and the DTC reviewers who drafted the letters did 

substantially more work to prepare for and respond to comments resulting 

from review by OCC. FDA officials told us that the agency issued letters 

for only the violative DTC materials that it considered the most serious 

and most likely to negatively affect consumers’ health. 

After the 2002 Policy 

Change, FDA’s 

Process for Issuing 

Regulatory Letters 

Took Longer and the 

Number of Letters 

Issued Declined 

Once FDA identified a violation in a DTC advertising material and 

determined that it merited a regulatory letter, FDA took several months to 

draft and issue a letter. For letters issued from 2002 through 2005, once 

DDMAC began drafting the 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. We 

recommended in 2002 that the agency reduce the amount of time to draft 

and issue letters and the agency agreed. We found in 2006, however, that 

the review time had increased and we again urged the agency to issue the 

letters more quickly. In 2006 and 2007, it took an average of more than 

5 months from drafting to issuance. One letter took less than 2 months to 

issue while another took about 11 months. (See fig. 2 for the average 

months from 1997 through 2007.) 

Page 9 GAO-08-758T
Figure 2: Average Months to Issue Regulatory Letters Citing Violative DTC Materials, 1997 through 2007 

Months to issue regulatory letters (initial draft to issuance)

0

1

2

3

4

5

6

1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007

Source: GAO analysis of FDA documents.

Year

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 that contributed to the increase in the length of FDA’s 

process for issuing regulatory letters was the additional work that resulted

from the 2002 policy change. All DDMAC regulatory letters were reviewed

by both OCC staff and OCC’s Chief Counsel. In addition to the time 

required of OCC, DDMAC officials told us that the policy change created 

the need for substantially more work on their part to prepare the 

necessary documentation for legal review. After meeting with OCC and 

revising the draft regulatory letter to reflect the comments from OCC, 

DDMAC would formally submit a draft letter to OCC for legal review and 

approval. OCC often required additional revisions before it would concur 

that a letter was legally supportable and could be issued. While OCC 

officials told us that the office had given regulatory letters that cited 

violative DTC materials higher priority than other types of regulatory 

letters, their review of DDMAC’s draft regulatory letters was a small 

portion of their other responsibilities and had to be balanced with other 

requests, such as the examination of legal issues surrounding the approval 

of a new drug. Recently, FDA informed us that it now allows some steps to 

be eliminated—if deemed unnecessary for a particular letter—in an 

attempt to make the legal review process more efficient. 

Page 10 GAO-08-758T
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. Prior to the 

policy change, 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. More recently, we found that the 

number of letters issued that cite DTC materials has continued to 

decline—FDA issued 4 letters in 2006 and 2 letters in 2007. (See fig. 3 for 

the number of letters issued from 1997 through 2007.) 

Figure 3: Number of Regulatory Letters FDA Issued That Cited DTC Advertising Materials, 1997 through 2007 

Numbers of letters

Year

Warning letters

Untitled letters

Source: GAO analysis of FDA regulatory letters.

0

5

10

15

20

25

30

1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007

Page 11 GAO-08-758T
Although the total number of regulatory letters FDA issued for violative 

DTC materials has decreased, the agency has issued in recent years 

proportionately more warning letters—which cite violations FDA 

considers to be more serious. 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 citing DTC advertising materials, 6 of which were warning letters. 

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

letters. Of the 6 letters FDA issued for DTC materials in 2006 and 2007, 4 

were warning letters. 

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

violation for a given drug. Of the 19 regulatory letters FDA issued from 

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

different materials. These 31 materials appeared in a range of media, 

including television, radio, print, direct mail, and the 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. The letters also often cited materials for overstating the

effectiveness of the drug or using misleading comparative claims. Of the 6 

regulatory letters FDA issued in 2006 or 2007 that cited DTC materials, 2 

cited more than 1 DTC material and all identified multiple violations in 

each of the cited materials. 

For our 2006 report, FDA officials told us, that the agency issued 

regulatory letters for DTC materials that it believed were the most likely to 

negatively affect consumers and that it did not act on all of the concerns 

that its reviewers identified. For example, they said the agency may be

more likely to issue a letter when a false or misleading material was 

broadly disseminated. When reviewers had concerns about DTC materials, 

they discussed them with others in DDMAC and may have met with OCC 

and medical officers in FDA’s Office of New Drugs to determine whether a 

regulatory letter was warranted. However, because FDA did 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. 

Page 12 GAO-08-758T
At the time of our 2006 report, we found that FDA regulatory letters were 

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 which time 

more than half of the materials had already been discontinued. Although 

drug companies complied with FDA’s requests to create materials to 

correct the misimpressions left by the cited materials, these corrections 

were not disseminated until 5 months or more after FDA issued the 

regulatory letter. Furthermore, FDA’s regulatory 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 Was Limited 

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, and 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 

effect 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. However, by the time 

the letters were issued, these 14 materials had been disseminated for an 

average of about 7 months.12

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. In addition to halting 

materials directed to consumers, companies responding to 11 letters also 

 12For one violative advertising material, we were unable to determine from FDA’s files 

when the violative advertising material ended. 

Page 13 GAO-08-758T
stopped disseminating materials with similar claims that were targeted 

directly to medical professionals. 

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 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 regulatory letters did 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. 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.13 For 15 of the 25 drugs, FDA cited similar broad 

categories of violations in multiple regulatory letters. 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.” For 4 of 

the 15 drugs, FDA cited the same specific violative claim for the same drug 

in more than one regulatory letter. 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. 

 13In 2006 and 2007, FDA issued 6 letters for drugs that had not previously been cited in 

regulatory letters. As of April 2008, the agency had issued one regulatory letter for a drug 

that had been cited in 2 previous regulatory letters. 

Page 14 GAO-08-758T
Given substantial growth in the number of DTC advertising materials 

submitted to FDA in recent years, FDA’s role in limiting the dissemination 

of false or misleading advertising to the American public has become 

increasingly important. Fulfilling this responsibility requires that the 

agency, among other things, review those DTC advertising materials that 

are highest priority and take timely action to limit the dissemination of 

those that are false or misleading. We found in 2006 that FDA did not have 

a complete and systematic process for tracking and prioritizing all 

materials that it received for review. FDA’s development of documented 

criteria to prioritize reviews is a step in the right direction. However, as we 

recommended in 2006, we believe that FDA should take the next step of 

systematically applying those criteria to the DTC materials it receives to 

determine which are highest priority for review. While the agency said that 

it would require vastly increased staff to systematically screen materials, 

we found in 2006 that FDA already has most of the information it would 

need to do so. Finally, despite FDA agreeing in 2002 that it is important to 

issue regulatory letters more quickly, the amount of time it takes to draft 

and issue letters has continued to lengthen. We believe that delays in 

issuing regulatory letters limit FDA’s effectiveness in overseeing DTC 

advertising and in reducing consumers’ exposure to false and misleading 

advertising.

Mr. Chairman, this completes my prepared statement. I would be happy to

respond to any questions you or the other members of the subcommittee 

may have at this time. 

For further information about this statement, please contact 

Marcia Crosse, at (202) 512-7114 or crossem@gao.gov. Contact points 

for our Offices of Congressional Relations and Public Affairs may be 

found on the last page of this statement. Martin T. Gahart, Assistant 

Director; Chad Davenport; William Hadley; Cathy Hamann; Julian Klazkin; 

and Eden Savino made key contributions to this statement. 

Concluding 

Observations 

Contacts and 

Acknowledgments 

(290715) Page 15 GAO-08-758T
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