Earlier today, FDA issued a Federal Register notice explaining the new Direct-to-Consumer (“DTC”) user fee program established by the FDA Amendments Act of 2007 (“FDAAA”) and requesting companies to notify the Agency within 30 calendar days whether they intend to participate in the program during FY 2008 – and if so to identify the number of planned DTC television ads in that period. The notice, as well as other information, is also available on FDA’s Division of Drug Marketing, Advertising, and Communications (“DDMAC”) DTC user fee website. FDA’s DTC advertisement user fee Performance Goals are available here (see Section B) and describe the Agency’s phased-in performance metrics through FY 2012.
The new DTC user fee program, codified at FDC Act § 736A (“Fees Relating to Advisory Review of Prescription-Drug Television Advertising”) is voluntary and authorizes FDA to assess and collect fees for the pre-dissemination review of DTC televisions ads. Under the new program, FDA will review and provide comments regarding its view of a submitted DTC advertisement’s compliance with the FDC Act, provided that the established user fee has been paid and that the advertisement has not yet been disseminated. Applicants need not avail themselves of this new system and can instead continue to submit DTC advertisements to FDA in their normal course of business. Any advertisements for which FDA pre-dissemination review is required are not subject to the user fees authorized by FDC Act § 736A.
Although FDAAA established an upper limit of $83,000 per submission for the FY 2008 fee, FDA explains in the notice that:
The fee will be based on the number of advertisements identified in response to this participation notice. The advisory review fees in FY 2008 will be set at a level to generate target revenues of $6.25 million in the first year of the program. Individual fees will be determined by dividing the target revenue, established in the statute, by the number of proposed television advertisements that all companies have indicated (in response to the participation notice) that they intend to submit during FY 2008.
The DTC user fees the Agency collects will be used to fund approximately 27 additional DDMAC staff for the Division’s pre-dissemination advisory review.
Whether or not the new DTC user fee program will actually be implemented will depend on how many companies commit to the program. FDAAA provides that the program will not commence if FDA fails to receive at least $11.25 million within 120 days after enactment of FDAAA (i.e., January 25, 2008).
The DTC user fee program is one of two DTC provisions included in FDAAA. FDAAA also amended the FDC Act to create § 503B (“Prereview of Television Advertisements”), which gives FDA the authority to require pre-review of television advertisements. FDA’s authority under this provision is generally limited to providing recommendations after reviewing an ad. FDA may require a change if it addresses a serious risk with the drug, or if the Agency requires the inclusion of the approval date in the ad (which may occur for up to 2 years after approval).