FDA Prepares for New DTC User Fee Program

Rockville, MD (Oct. 19)-In accordance with the US Food and Drug Administration Amendments Act of 2007, FDA is asking companies to notify the agency within 30 days whether they intend to participate in FDA’s direct-to-consumer (DTC) user-fee program during fiscal year 2008 (FY 2008). If companies are planning to participate, they must identify the number of DTC television advertisements for prescription drug and biological products they plan to submit for advisory review during FY 2008.

The information gathered during this time period will be used to establish the FY 2008 fee that will be charged for each advisory review submission to FDA and to create an operating reserve. The new DTC user-fee program was signed into law in Sept. 2007 as part of the reauthorization of the Prescription Drug User Fee Act. Participation in the program is voluntary.

FDA received an average of approximately 150 television advertisements for advisory review each year between 2000 and 2006. According to the agency notice, “…companies can benefit from FDA’s advice on whether or not the advertisements are accurate, balanced, and adequately supported. The submission of advertisements for advisory review gives sponsors the opportunity to address any problems before the advertisements are shown to the public and can improve the quality of the advertisements.” The Pharmaceutical Research and Manufacturers of America (PhRMA) has stated its support of the program and has encouraged companies to submit advertisements for FDA review before broadcasting them. A copy of PhRMA’s “Guiding Principles; Direct to Consumer Advertisements About Prescription Medicines’’ is available here.

FDA’s explanation of the DTC user fee program is available

here

.