US FDA scraps DTC ad review program

The US Food and Drug Administration has informed drugmakers via an announcement in the Federal Register that the direct-to-consumer television advertisement user fee program (Marketletters passim) has been postponed because the necessary user fees for the program were not "provided in advance in appropriations Acts." The agency argues that the terms of Food and Drug Administration Amendments Act of 2007 required separate legislative approval. A previously-issued notice establishing user fee rates for the program for fiscal year 2008 has therefore been withdrawn.

A fee of $41,390 for each advertisement to be reviewed by the FDA had been expected. Mark Tosh, editor of DTC Perspectives, noted that 31 marketing firms has signed up to submit 151 television advertisements for review before general release. Instead, the federal agency said it would continue to review DTC advertisement on "as timely a basis as resources will permit" without charging user fees. An extra 27 reviewer positions at the FDA would have been available, without the latest development. Mr Tosh added that opposition in Congress to drugmaker fees was behind the impasse.