Direct-to-Consumer (DTC) Television User Fee Program Documents
1/15/2008: The Food and Drug Administration (FDA) is issuing this notice to inform companies that the Direct-to-Consumer (DTC) television advertisement user fee program will not commence because the necessary user fees for the program were not "provided in advance in appropriations Acts" as required by the Food and Drug Administration Amendments Act of 2007 (FDAAA). Federal Register notice [HTML] [PDF]
If you have questions about the DTC user fee program or about submitting DTC TV ads for advisory review, please contact either Mrs. Olga Salis or Mr. Michael Wade at (301) 796-1200.
Proposed DTC TV Advertisements Voluntarily Submitted for OPDP Advisory Review
Since the DTC User Fee Program will not be implemented, all direct-to-consumer (DTC) television advertisements voluntarily submitted for OPDP advisory review should be sent directly to FDA’s central document room to the attention of OPDP’s Project Management Team. Please send these submissions to:
Food and Drug Administration
Center for Drug Evaluation and Research
Office of Prescription Drug Promotion
5901-B Ammendale Road
Beltsville, MD 20705-1266
Attention: DTC TV Ad for Advisory Review
OPDP strongly encourages companies to note on the exterior package that the submission is a proposed DTC TV ad for OPDP advisory review. Companies with questions about submission of proposed DTC TV advertisements should contact Mrs. Olga Salis or Mr. Michael Wade at 301-796-1200 or by email at firstname.lastname@example.org or email@example.com.
Companies planning to send more than one proposed DTC television advertisement to OPDP for advisory review should not consolidate them into one submission. Each proposed DTC television advertisement for advisory review should be submitted separately (not bundled together), and each submission should be complete and reviewable as a stand-alone submission.
What Constitutes a Complete and Reviewable DTC TV Submission?
Please visit OPDP’s submission page for information on what constitutes a complete and reviewable DTC TV submission, and for information on other submissions. OPDP’s submissions web page is available at Submission of Proposed DTC TV Ads for Advisory Review.
Federal Register Documents Concerning the DTC User Fee Program
- DTC User Fee Program Will Not be Implemented [HTML] [PDF] (1/16/08)
- User Fee Program for Advisory Review of Direct-to-Consumer Television Advertisements for Prescription Drug and Biological Products; Request for Notification of Participation and Number of Advertisements for Review [HTML] [PDF] (posted 10/25/2007)
- Federal Register Notice: Establishment of Fiscal Year 2008 User Fee Rates for Advisory Review of Direct-to-Consumer Television Advertisements for Prescription Drug and Biological Products. [HTML] [PDF] (12/13/2007)