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FDA Begins Reviewing DTC Ads As User Fee Program Faces Pay Or Die Deadline

Executive Summary

Industry already has submitted 12 direct-to-consumer television ads to FDA for pre-review through the new DTC user fee program

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The price of DTC TV ad reviews

FDA is charging pharmaceutical companies $41,390 to review a direct-to-consumer television ad during fiscal year 2008. The fees are based on company commitments to submit 151 ads for review and the need to generate $6.25 million to pay for FDA review activities and set up an operating reserve fund. The FDA Amendments Act, which establishes the voluntary DTC user fee program, requires collection of the fees within 120 days of the law's Sept. 27 enactment (1"The Pink Sheet" Nov. 26, 2007, p. 5). FDA is writing guidance on submission contents, format and procedures, but has given no date for its release...

The price of DTC TV ad reviews

FDA is charging pharmaceutical companies $41,390 to review a direct-to-consumer television ad during fiscal year 2008. The fees are based on company commitments to submit 151 ads for review and the need to generate $6.25 million to pay for FDA review activities and set up an operating reserve fund. The FDA Amendments Act, which establishes the voluntary DTC user fee program, requires collection of the fees within 120 days of the law's Sept. 27 enactment (1"The Pink Sheet" Nov. 26, 2007, p. 5). FDA is writing guidance on submission contents, format and procedures, but has given no date for its release...

DTC clock ticking

Drug sponsors must notify FDA by Nov. 26 if they intend to submit DTC television ads to the agency for pre-broadcast review in fiscal 2008. Such a notification constitutes a legally binding commitment to pay a review fee, which will be calculated based on the number of ads to be reviewed (1"The Pink Sheet" Oct. 1, 2007, p. 4). The DTC user fee program, authorized by the FDA Amendments Act, will fund about 27 additional staff, enabling more rapid ad review. Guidance is forthcoming on contents, format and procedures for submitting DTC packages for review, the Oct. 25 Federal Register states...

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