	Background

FDA regulates the content of all prescription drug advertising, whether  directed to consumers or medical professionals. In March 2002,  DDMAC created a DTC Review Group, which is responsible for oversight  of advertising materials that are directed to consumers. 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. FDA received a steadily  increasing number of final materials from 1999 through 2005. 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. 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. We reported in 2006 that FDA did not systematically apply its criteria for  prioritizing reviews to all of the materials that it received. 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. 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. 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. These 31 materials appeared in a range of media,  including television, radio, print, direct mail, and the Internet. 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. Furthermore, FDA’s regulatory letters did not always  prevent drug companies from later disseminating similar violative  materials for the same drugs. 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. 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.
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 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.

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, 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.