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FDA announces user fee rates for DTC voluntary review program

Pharma Compliance Alert, January 2, 2008

Pharmaceutical companies that want the FDA to review direct-to-consumer (DTC) advertising will pay $41,390 per ad submitted in fiscal year 2008, according to a Federal Register notice.

In a previous Federal Register notice, the FDA asked companies how many ads they planned to submit in FY 2008 and based the fees on that number. Companies that submit more ads than they planned will pay an additional 50% per ad, while companies that did not indicate they planned to submit ads for review will also pay 50% more.

In addition, companies will pay a one-time fee during the first year they participate in the program. Companies who join in FY 2009 through FY 2012 will have to pay an operating reserve fee that is either the total amount of advisory reviews for all of the company's proposed DTC ads for that year or the total amount of review fees that would have been assessed in fiscal 2008, whichever is higher.

Click here to read the notice in the Federal Register.

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