Prescription Drugs: Trends in FDA's Oversight of Direct-to-Consumer Advertising
Published: 2008-05-08T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: 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.
section_title: What GAO Found
paragraphs: 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.

section_title: Letter
paragraphs: 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. 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. 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. 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. 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.
subsections: section_title: Background
paragraphs: 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. 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.
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. 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.
section_title: FDA Reviewed a Small Portion of DTC Materials and Could Not Ensure It Was Reviewing the Highest-Priority Materials
paragraphs: 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. 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. (See  fig. 1.)
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.
section_title: After the 2002 Policy Change, FDA’s Process for Issuing Regulatory Letters Took Longer and the Number of Letters Issued Declined
paragraphs: 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.)
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.)
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.
section_title: Effectiveness of FDA Regulatory Letters at Halting Dissemination of Violative DTC Materials Was Limited
paragraphs: 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.
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. 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.
section_title: Concluding Observations
paragraphs: 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.
section_title: Contacts and Acknowledgments
paragraphs: 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.
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