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 

 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.”

News

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.