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 A previously-issued notice establishing user fee rates for the program for fiscal year 2008 has therefore been withdrawn.

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.

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK





Today's issue

Company Spotlight