US FDA scraps DTC ad review program

28 January 2008

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 A previously-issued notice establishing user fee rates for the program for fiscal year 2008 has therefore been withdrawn.

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