News: Prescription Drug Television Advertisement Advisory Review Fees – Not This Year

Posted 01 March 2008 | By

As previously reported (see Regulatory Affairs Focus, December 2007), the Food and Drug Administration Amendments Act of 2007 (FDAAA) included a provision requiring the payment of fees for advisory review of prescription drug television advertisements by the Food and Drug Administration (FDA).1 At the end of last year, it appeared that this program was on track. On 25 October 2007, FDA issued a Federal Register notice requesting notifications of expected advisory review submissions for Fiscal 2008.2 On 11 December 2007, FDA announced that, based upon the number of notifications received from industry,3 the advisory review fee for Fiscal 2008 would be $41,390 for each proposed television advertisement voluntarily submitted for advisory review.4


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