Pay Per View: Why Fees for DTC Might Fly
This article was originally published in RPM Report
The pharma industry is promising to preclear its ads with FDA. The problem is, FDA's ad review group is already overworked. Some in industry think the answer is to expand the user fee program to include fees for DTC.
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FDA is proposing that drug sponsors assume responsibility for testing proprietary trademarks for potential medication errors before they are reviewed by the agency. That -- along with performance goals tied to user fee dollars -- should help speed up the review of proposed brand names.
Since the implementation of the PhRMA direct-to-consumer advertising guidelines in January 2006, FDA hasn't taken a single enforcement action against a consumer-directed prescription drug print or TV ad. That's good news for an industry trying to quiet critics on Capitol Hill in the run-up of the reauthorization of the Prescription Drug User Fee Act.
The pharmaceutical industry and FDA are getting ready for a fight-and for once they are on the same side. They want Congress to reauthorize the Prescription Drug User Fee Act quickly and cleanly-without tacking on other reforms to FDA's drug regulations. They probably won't get their wish.