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FDA SUPPORTS 'PAY TO PLAY' APPROACH TO DTC USER FEES

December 13, 2006

The FDA is supporting a user fee program for direct-to-consumer (DTC) advertising, where companies are only required to pay when they have ads up for review, a high-ranking agency official said.

The FDA has been in negotiations with industry officials over a new user fee system to fund the agency's review of drug advertising as part of the closed-door Prescription Drug User Fee Act negotiations. The FDA has tentatively agreed to a "pay to play" approach where companies that do not submit advertising do not have to pay these fees, Scott Gottlieb, the agency's deputy commissioner for medical and scientific affairs, said.

The FDA, PhRMA and the Biotechnology Industry Organization will soon issue an agreement under which industry will pay the agency fees for DTC ad reviews, pending the parties finalizing the legal structure for the agreement. The funds are meant to ensure faster reviews of these ads. Industry also agreed to the fees to head off potential legislation mandating preapproval of DTC ads, an industry source said.