May 13, 2008
GAO: FDA bureaucracy gums up DTC reviews
A Government Accountability Office report said the FDA has failed to implement an effective system for tracking and prioritizing reviews of DTC ads – and that the gap between reviews of violative ads and the issuance of regulatory letters continues to widen as a result.
From 1997-2002, the report said, it took an average of two weeks for FDA to issue a regulatory letter. Since 2002, when the FDA implemented a policy change requiring internal legal review of all draft regulatory letters, the process has taken longer – four months, on average, from 2002-2005 – and fewer letters have been issued. In 2006 and 2007, average response time lengthened to more than five months.
Two years ago, the GAO prodded the agency to begin tracking which ads were reviewed and develop a system for prioritizing reviews in order to promote more timely issuance of warning and untitled letters. The agency, said the report, has “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, the agency has not yet implemented a system for identifying what ads have been reviewed, as the GAO recommended in 2006.
In prepared remarks to Congress, GAO healthcare head Marcia Crosse praised the agency's development of prioritization criteria but knocked its failure to implement those criteria and track reviews. “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,” said Cross. “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.”