The price of DTC TV ad reviews
Executive Summary
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...