October 26th, 2007

FDA Requests Information on DTC Advertisements for Review Program

FDA News

Companies must notify the FDA shortly if they intend to participate in the agency’s direct-to-consumer (DTC) advertisement review program in fiscal 2008 or they will face higher user fees.

The FDA is collecting information on the number of companies planning to present DTC television ads for review and the number of ads each company plans to submit, according to a notice in the Oct. 25 Federal Register. The information will be used to establish the fiscal 2008 user fee amount charged for each submission during the fiscal year.

The FDA Amendments Act (FDAAA) established new user fee programs for the voluntary review of DTC advertisements. Companies submitting advertisements will pay two user fees: one for each advertisement submitted and one paid during the company’s first year of participation in the program to establish a reserve fund.

The agency will use the fees to hire 27 staff members to review submissions in fiscal 2008. The fee levels will be set to generate revenues of $6.25 million in the program’s first year. Between 2000 and 2006, the FDA received an average of 150 television advertisements for review each year.

If the FDA does not receive sufficient funding — at least $11.25 million from both user fee programs — within 120 days after the bill’s enactment, the user fee review program will not start.

The FDA will issue another notice in the Federal Register establishing the user fee amount for fiscal 2008 once companies respond. The user fee covers an initial submission and a resubmission after FDA comment. Companies will not have to pay fees for advertisements required for FDA review before dissemination, such as those for accelerated approval drugs. 

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