FDA proposes PDUFA V, two new user fee programs to Congress

Agency includes REMS improvements, seeks user fee programs for human generic drugs, biosimilars.

Congress received FDA’s proposals for two new user fee programs for human generic drugs and biosimilars and for the fifth reauthorization of the Prescription Drug User Fee Act (PDUFA V) on January 13, according to an FDA news release.

The proposed user fee programs for generic drugs and for biosimilars (one of many terms for the generic versions of biologics) were modeled on the successful PDUFA user fee program for new drugs and biologics, according to the news release.

User fee programs allow FDA to collect user fees from industry to help fund the agency’s timely review of drug applications. PDUFA is up for reauthorization in September 2012. FDA’s transmission of recommendations for PDUFA reauthorization to Congress kicked off congressional activity leading up to the September deadline.

Originally enacted in 1992, PDUFA must be reauthorized by Congress every 5 years. PDUFA IV was reauthorized under the FDA Amendments Act of 2007, and includes authority for FDA to require manufacturers to develop and comply with Risk Evaluation and Mitigation Strategies (REMS) to mitigate safety issues for certain drugs through components such as a communication plan or restricted distribution through Elements to Assure Safe Use.

FDA’s PDUFA V recommendations included improvements to REMS that APhA supports and advocated for at FDA’s public hearing in November 2011. Improving REMS is a priority for the Association.  For additional information on efforts to improve REMS, see the APhA 2011 REMS White Paper

The proposed Biosimilar and Interchangeable Products User Fee program would be for products approved using a new abbreviated approval pathway for biosimilars under the Biologics Price Competition and Innovation Act of 2009, part of the Affordable Care Act of 2010. The proposed Generic Drug User Fee Act would be for new applications for generic drugs; FDA receives 800 to 900 such applications annually. Generic drugs account for two-thirds of all prescriptions dispensed in the United States.