The New Prescription Drug User Fee Program for DTC for Drug and Bio Products

Tomorrow, the FDA will be publishing a Notice entitled the "User Fee Program for Advisory Review of Direct-to-Consumer Television Advertisements for Prescription Drug and Biologic Products; Request for Notification of Participation and nUmber of Advertisements for Review" - A MOUTHFUL! 

This is a direct result of the legislation recently passed - the Food and Drug Administration Amendments Act of 2007 (FDAAA) and signed into law on September 27, 2007.  As noted in a recent post on the issue, this new power by the FDA raises some intriguing and important matters to be considered for pharma marketing as well as something of a Sophie's Choice (See Show Me the Money). 

The notice is asking companies to decide now (within the next 30 days) whether or not they plan to participate in the program (again, see Show Me the Money) and if they do, how many advertisements they are going to have reviewed under the program.

For those needing a refresher course, the law creates a new user fee program for the review of DTC prescription drug television ads in advance of their airing.  If you get reviewed - no Warning Letter.  If you don't and you do get a Warning Letter, it can be a painful one.  But the FDA wants to know now how many you will be submitting so that the user fee that is going to be charged can be calculated.  For those who oppose user fees because it is thought they bring the agency in charge of regulating the industry too close to the industry, you are going to be frustrated by this development.  But you may not be the only one.  In either case, the agency is going to be extracting money from pharma companies, even though enforcement of DTC as expressed through Warning Letters has seriously declined. 

So, if you are a pharma or bio company, and you haven't decided anything on this issue, the clock begins ticking - presumably tomorrow when the notice is scheduled to be published in the Federal Register.