Prescription Drugs: Trends in FDA's Oversight of		 
Direct-to-Consumer Advertising (08-MAY-08, GAO-08-758T).	 
                                                                 
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.						 
-------------------------Indexing Terms------------------------- 
REPORTNUM:   GAO-08-758T					        
    ACCNO:   A82020						        
  TITLE:     Prescription Drugs: Trends in FDA's Oversight of	      
Direct-to-Consumer Advertising					 
     DATE:   05/08/2008 
  SUBJECT:   Advertising					 
	     Consumer protection				 
	     Cost analysis					 
	     Evaluation criteria				 
	     Federal regulations				 
	     Food and drug law					 
	     Government information dissemination		 
	     Pharmaceutical industry				 
	     Policy evaluation					 
	     Prescription drugs 				 
	     Public health					 
	     Regulatory agencies				 
	     Sales promotion					 
	     Schedule slippages 				 
	     Surveys						 
	     Television advertising				 
	     Policies and procedures				 

******************************************************************
** This file contains an ASCII representation of the text of a  **
** GAO Product.                                                 **
**                                                              **
** No attempt has been made to display graphic images, although **
** figure captions are reproduced.  Tables are included, but    **
** may not resemble those in the printed version.               **
**                                                              **
** Please see the PDF (Portable Document Format) file, when     **
** available, for a complete electronic file of the printed     **
** document's contents.                                         **
**                                                              **
******************************************************************
GAO-08-758T

   

This is a work of the U.S. government and is not subject to copyright 
protection in the United States. It may be reproduced and distributed 
in its entirety without further permission from GAO. Because this work 
may contain copyrighted images or other material, permission from the 
copyright holder may be necessary if you wish to reproduce this 
material separately. 

Testimony: 

Before the Subcommittee on Oversight and Investigations, Committee on 
Energy and Commerce, House of Representatives: 

United States Government Accountability Office: 

GAO: 

For Release on Delivery Expected at 10:00 a.m. EDT: 

Thursday, May 8, 2008: 

Prescription Drugs: 

Trends in FDA's Oversight of Direct-to-Consumer Advertising: 

Statement of Marcia Crosse: 

Director, Health Care: 

GAO-08-758T: 

GAO Highlights: 

Highlights of GAO-08-758T, a testimony before the Subcommittee on 
Oversight and Investigations, Committee on Energy and Commerce, House 
of Representatives. 

Why GAO Did This Study: 

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 FDAï¿½s issuance of regulatory letters. 

GAO was asked to discuss trends in FDAï¿½s oversight of DTC advertising 
and the actions FDA has taken when it identifies violations. This 
statement is based on GAOï¿½s 2006 report, Prescription Drugs: 
Improvements Needed in FDAï¿½s 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) FDAï¿½s 
process for issuing regulatory letters citing DTC advertising materials 
and the number of letters issued, and (3) the effectiveness of FDAï¿½s 
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. 

What GAO Found: 

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, FDAï¿½s 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 FDAï¿½s 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, 
FDAï¿½s issuance of regulatory letters had not always prevented drug 
companies from later disseminating similar violative materials for the 
same drugs. 

To view the full product, including the scope and methodology, click on 
[hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-08-758T]. For more 
information, contact Marcia Crosse, (202) 512-7114, [email protected] 

[End of section] 

Mr. Chairman and Members of the Subcommittee: 

I am pleased to be here today as you examine the practice of direct-to- 
consumer (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.[Footnote 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.[Footnote 
2],[Footnote 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 violations in 
DTC materials.[Footnote 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.[Footnote 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. 

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. 

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. 

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). 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. 

Advertising materials must contain a "true statement" of information 
including a brief summary of side effects, contraindications, and the 
effectiveness of the drug.[Footnote 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 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.[Footnote 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 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.[Footnote 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.[Footnote 9] 

FDA Reviewed a Small Portion of DTC Materials and Could Not Ensure It 
Was Reviewing the Highest-Priority Materials: 

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 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 (excluding Internet materials) and 6,168 final Internet 
materials.[Footnote 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.[Footnote 11] (See fig. 1.) 

Figure 1: Number of Final DTC, Internet, and Consumer-Directed 
Materials Submitted to FDA, 1999 through 2007: 

This figure is a vertical bar graph showing number of final DTC, 
internet, and consumer-directed materials submitted to FDA, 1999 
through 2007. The X axis represents the year, and the Y axis represents 
the numbers in thousands. 

Year: 1999; 
Numbers in thousands: 6. 

Year: 2000; 
Numbers in thousands: 7. 

Year: 2001; 
Numbers in thousands: 9. 

Year: 2002; 
Numbers in thousands: 9. 

Year: 2003; 
Numbers in thousands: 10. 

Year: 2004; 
Numbers in thousands: 14. 

Year: 2005; 
Numbers in thousands: 15. 

Year: 2006; 
Numbers in thousands: 18. 

Year: 2007; 
Numbers in thousands: 21. 

(Numbers rounded to make whole numbers.) 

[See PDF for image] 

Source: GAO analysis of FDA data. 

[End of figure] 

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 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. 

After the 2002 Policy Change, FDA's Process for Issuing Regulatory 
Letters Took Longer and the Number of Letters Issued Declined: 

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. 

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.) 

Figure 2: Average Months to Issue Regulatory Letters Citing Violative 
DTC Materials, 1997 through 2007: 

This figure is a versicle bar graph showing average months to issue 
regulatory letters citing violative DTC materials, 1997 through 2007. 
The X axis represents the year, and the Y axis represents the months to 
issue regulatory letters (initial draft to issuance). 

Year: 1997; 
Months to issue regulatory letters: 0.3. 

Year: 1998; 
Months to issue regulatory letters: 0.3. 

Year: 1999; 
Months to issue regulatory letters: 0.7. 

Year: 2000; 
Months to issue regulatory letters: 0.7. 

Year: 2001; 
Months to issue regulatory letters: 0.7. 

Year: 2002; 
Months to issue regulatory letters: 2. 

Year: 2003; 
Months to issue regulatory letters: 4.6. 

2004; 
Months to issue regulatory letters: 5.1. 

Year: 2005; 
Months to issue regulatory letters: 3.5. 

Year: 2006; 
Months to issue regulatory letters: 4.63. 

Year: 2008; 
Months to issue regulatory letters: 6.17. 

[See PDF for image] 

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. 

[End of figure] 

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. 

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: 

This figure is a vertical combination bar graph showing number of 
regulatory letters FDA issued that cited DTC advertising materials, 
1997 to 2007. The X axis repredents the year, and the Y axis represents 
the numbers of letters. One bar represents the warning letters, and the 
second bar represents untitled letters. 

Year: 1997; 
Warning letters: 17; 
Untitled letters: 2. 

1998; 
Warning letters: 25; 
Untitled letters: 0. 

1999; 
Warning letters: 16; 
Untitled letters: 2. 

2000; 
Warning letters: 20; 
Untitled letters: 1. 

2001; 
Warning letters: 14; 
Untitled letters: 1. 

2002; 
Warning letters: 9; 
Untitled letters: 0. 

2003; 
Warning letters: 7; 
Untitled letters: 2. 

2004; 
Warning letters: 8; 
Untitled letters: 3. 

2005; 
Warning letters: 5; 
Untitled letters: 3. 

2006; 
Warning letters: 1; 
Untitled letters: 3. 

2007; 
Warning letters: 1; 
Untitled letters: 1. 

[See PDF for image] 

[End of figure] 

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. 

Effectiveness of FDA Regulatory Letters at Halting Dissemination of 
Violative DTC Materials Was Limited: 

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. 

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.[Footnote 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 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.[Footnote 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. 

Concluding Observations: 

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. 

Contacts and Acknowledgments: 

For further information about this statement, please contact Marcia 
Crosse, at (202) 512-7114 or [email protected]. 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. 

[End of section] 

Footnotes: 

[1] 21 C.F.R. ï¿½ 314.81(b)(3)(i)(2007). 

[2] 21 C.F.R. ï¿½ 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, ï¿½ 901(d)(2), 121 Stat. 823, 939 (2007), codified at 21 U.S.C. ï¿½ 
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), 
[hyperlink, http://www.phrma.org/files/DTCGuidingprinciples.pdf] 
(accessed Apr. 29, 2008). 

[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-to-Consumer Advertising, GAO-07-54 (Washington, D.C.: Nov. 16, 
2006). 

[6] 21 C.F.R. ï¿½ 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. 

[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). 

[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, ï¿½ 901(d)(4), 121 Stat. 823, 940-
942 (2007), codified at 21 U.S.C. ï¿½ 333(g). 

[9] See GAO-03-177, 32. 

[10] FDA'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. 

[11] We 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. 

[12] For one violative advertising material, we were unable to 
determine from FDA's files when the violative advertising material 
ended. 

[13] In 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.

GAO's Mission: 

The Government Accountability Office, the audit, evaluation and 
investigative arm of Congress, exists to support Congress in meeting 
its constitutional responsibilities and to help improve the performance 
and accountability of the federal government for the American people. 
GAO examines the use of public funds; evaluates federal programs and 
policies; and provides analyses, recommendations, and other assistance 
to help Congress make informed oversight, policy, and funding 
decisions. GAO's commitment to good government is reflected in its core 
values of accountability, integrity, and reliability.  

Obtaining Copies of GAO Reports and Testimony: 

The fastest and easiest way to obtain copies of GAO documents at no 
cost is through GAO's Web site [hyperlink, http://www.gao.gov]. Each 
weekday, GAO posts newly released reports, testimony, and 
correspondence on its Web site. To have GAO e-mail you a list of newly 
posted products every afternoon, go to [hyperlink, http://www.gao.gov] 
and select "E-mail Updates."  

Order by Mail or Phone: 

The first copy of each printed report is free. Additional copies are $2 
each. A check or money order should be made out to the Superintendent 
of Documents. GAO also accepts VISA and Mastercard. Orders for 100 or 
more copies mailed to a single address are discounted 25 percent. 
Orders should be sent to:  

U.S. Government Accountability Office: 
441 G Street NW, Room LM: 
Washington, D.C. 20548:  

To order by Phone: 
Voice: (202) 512-6000: 
TDD: (202) 512-2537: 
Fax: (202) 512-6061:  

To Report Fraud, Waste, and Abuse in Federal Programs:  

Contact:  

Web site: [hyperlink, http://www.gao.gov/fraudnet/fraudnet.htm]: 
E-mail: [email protected]: 
Automated answering system: (800) 424-5454 or (202) 512-7470:  

Congressional Relations:  

Ralph Dawn, Managing Director, [email protected]: 
(202) 512-4400: 
U.S. Government Accountability Office: 
441 G Street NW, Room 7125: 
Washington, D.C. 20548:  

Public Affairs: 

Chuck Young, Managing Director, [email protected]: 
(202) 512-4800: 
U.S. Government Accountability Office: 
441 G Street NW, Room 7149: 
Washington, D.C. 20548: 

*** End of document. ***