As we noted last week, the FDA completed its work on user fee programs affecting prescription drugs, generic drugs and biosimilars, sending the recommendations to Congress last week, ahead of the agency’s mid-January deadline. Here is a more in-depth look at the recommendations.
The programs include a reauthorization of the Prescription Drug User Fee Act (PDUFA) and two new user fee programs for human generic drugs and biosimilar biological products. PDUFA 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.
Under a user fee program, affected industry agrees to pay fees to help 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. PDUFA has been in use for the last 20 years and is cited by the FDA as speeding up the application review process of the agency without compromising its regulatory work.
The newly proposed user fee programs for generic drugs and biosimilars were modeled on the PDUFA program.
The proposed Generic Drug User Fee Act (GDUFA) program would provide the FDA with funding to assist the agency in ensuring continued consumer 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. If GDUFA is established, the FDA expects that the review backlog of generic drugs would be eliminated.
Additionally, under the Biosimilar and Interchangeable Products User Fee program, products would be approved under a new abbreviated approval pathway for biological products shown to be biosimilar to or interchangeable with an FDA-licensed biological product. A biosimilar is a biological product that is highly similar to a U.S.-licensed reference biological product notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product. The Patient Protection and Affordable Care Act of 2010 (P.L. 111-148) contained a subtitle called the Biologics Price Competition and Innovation Act (BPCI) of 2009, which established the generic user fee pathway.
The recommended user fee program for biosimilars includes fees for products in development to generate revenue in the near-term and to provide the FDA with the resources needed to support development-phase meetings with sponsors of biosimilar biological product candidates.
GDUFA would impact industry most rapidly, as biosimilars are still comparatively less established in terms of research and development among pharma.