User Fee Programs

On January 13, 2012 the FDA announced it had completed its recommendations for three user fee programs and sent the recommendations to Congress. The user fee programs are:

  • The fifth authorization of the Prescription Drug User Fee Act (PDUFA);  
  • A new user fee programs for human generic drugs; and
  • A new user fee program for biosimilar biological products.

These user fee programs create revenue through fees paid by the industry that fund a portion of the FDA’s drug review activities while the FDA agrees to overall performance goals such as reviewing a certain percentage of applications within a particular time frame. According to the FDA;

The proposed new Generic Drug User Fee program would provide the FDA with needed funding at a time when generic drug applications are on the rise. Generic drug user fees would help ensure consumers timely access to safe, high-quality and effective generic drugs, which account for two-thirds of all prescriptions dispensed in the U.S.
 The FDA receives 800 to 900 new generic-drug-related applications annually. These applications are increasingly complex and frequently involve products manufactured outside of the U.S. In exchange for fees on facilities and product applications, the proposal includes performance metrics such as review timeframes and a commitment to achieve parity between surveillance inspections of foreign and domestic establishments by the 2017 fiscal year. As a result, FDA expects that the proposal would effectively eliminate the review backlog and significantly reduce review times.
The FDA also stated that the prescription drug user fee programs promote safety, transparency and access to drugs. Time will tell if Congress will approve all three programs, but in an election year cycle, anything is possible.