On Jan. 13, 2012, FDA announced it had completed, and transmitted to Congress, its recommendations for three user fee programs including the fifth authorization of the Prescription Drug User Fee Act (PDUFA) and programs for human generic drugs and biosimilar biological products.
FDA modeled the proposed user fee programs on the PDUFA created by Congress in 1992. Commissioner Margaret A. Hamburg, PhD, stated in a FDA press release that the PDUFA has “ensured a predictable, consistent, and streamlined premarket program for prescription drugs.” Under the programs, the pharmaceutical industry helps to fund a portion of FDA’s drug review activities by paying fees. In return, FDA agrees to process applications in a particular timeframe as well as other performance goals.
Commissioner Hamburg stated, “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.” With the recommended programs, FDA would be able to continue to conduct timely reviews of critical prescription drugs, provide communication with small and emerging companies, promote the use of electronic data, and advance drug development for rare diseases.
The generic-drug market has been growing and applications for new generic drugs have been on the rise. FDA stated in the press release that the proposed Generic Drug User Fee program would ensure that the agency had the necessary funding to process new generic drug applications. The proposal includes review timeframes that would reduce the review backlog and provides a “commitment to achieve parity between surveillance inspections of foreign and domestic establishments by the 2017 fiscal year.”
FDA intends for fees included in the Biosimilar and Interchangeable Products User Fee program to generate revenue in the near-term and support development-phase meetings with sponsors. FDA stated that the proposed biosimilar program would spur competition in the biologic drug market by allowing companies to develop alternative products. According to FDA, a biosimilar is “a biological product that is highly similar to a US-licensed reference biological product notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biologic product and the reference product in terms of safety, purity, and potency of the product.”