The FDA is preparing to launch formal user-fee negotiations with generic-drug makers by the end of the month, and agency officials are taking a hard line with industry in the build up. Saying there is a “significant fairness factor” in imposing the fees, Peter Beckerman, a senior policy advisor in the FDA Office of the Commissioner, told generic-drug makers Thursday that their industry should not be exempt from a program that both brand drug and medical-device makers are already a part of. FDA officials have been mounting a push for the creation of a user-fee program for several months now, as the agency’s backlog of generic drug applications has grown to more than 2,000.
Washington Drug Letter