The FDA completed its recommendations Jan. 17 for three user fee programs to help speed safe and effective drugs and lower-cost generic drug and biosimilar biological products to patients.
The programs include the fifth authorization of the Prescription Drug User Fee Act (PDUFA), and new user fee programs for human generic drugs and biosimilar biological products, modeled after PDUFA. Work on the proposals was concluded before the agency’s mid-January deadline.
In a user fee program, industry pays fees to help fund a portion of the FDA’s drug review activities, and in exchange the FDA will adhere to overall performance goals such as reviewing a certain percentage of applications within a set time frame.
PDUFA, the first program, was created by Congress in 1992 and must be reauthorized every five years. The current program, known as PDUFA IV, will expire on Sept. 30, 2012, unless reauthorized by Congress. FDA’s recommendations for PDUFA V were developed in consultation both with drug industry representatives and with patient and consumer advocates.
The second proposed program is the new Generic Drug User Fee program, which would provide the FDA with needed funding at a time when generic drug applications are on the rise. The FDA receives 800 to 900 genetic-drug-related applications annually. 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 third program is the proposed Biosimilar and Interchangeable Products User Fee program, intended for products approved under a new abbreviated approval pathway for biological products shown to be biosimilar to or interchangeable with an FDA-licensed biological product. The Affordable Care Act of 2010 contains a subtitle called the Biologics Price Competition and Innovation Act (BPCI) of 2009, which established this pathway.
Under the recommendations, fees paid by industry would support the FDA’s continued timely review of critical prescription drugs, advance the development of drugs for rare diseases, increase the use of standardized electronic data to improve quality and efficiency, provide for enhanced communication with small or emerging companies and foster the use of new clinical endpoints that improve drug development times and help address unmet medical needs.
“These final recommendations offer a great example of what can be achieved when the FDA, industry and other stakeholders work together on the same goal,” said Margaret A. Hamburg, FDA Commissioner. “At a time of greater budgetary constraint, user fees provide a critical way for leveraging appropriated dollars, ensuring that FDA has the resources needed to conduct reviews in a timely fashion.”
Hamburg says the FDA hopes the three new programs will eliminate the review backlog and significantly reduce review times.