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Jan24
FDA DTC User Fees: Dead In The Water

Last week, the FDA announced that its controversial direct-to-consumertombstone.jpeg advertising user fee program was being discontinued.  The reason: lack of funds.  Another: A less than enthusiastic response from the pharmaceutical industry.

According to PharmaExec.com: “When President Bush signed the Prescription Drug User Fee Act in September last year, he included a provision that if FDA failed to raise at least $11.2 million in review fees by January 25, 2008, the program would be null and void.

Additionally, Congress sealed the program's fate on December 26 by declining funding for the user fee program and instead giving $4 million to fund traditional DTC prereviews.”

However, government wasn’t the only player less than enthusiastic about the user fee program.  Advertising agencies were not willing to shell out hundreds of thousands to get a seat at the table and have advertisements reviewed.  In addition, it was less than clear whether an advertisement would be immune from future censure after being pre-approved by the agency.

Right now it is unclear whether the DTC user fee initiative will be resuscitated.  Those seeking to revive it must overcome numerous barriers, especially the current political climate. 

 


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