The proposed Generic Drug User Fee program (PDF) and the Biosimilar and Interchangeable Products User Fee program (PDF) are based on the Prescription Drug User Fee Act, according to the FDA.
FDA Commissioner Dr. Margaret Hamburg said in the news release that the original program “ensured a predictable, consistent, and streamlined premarket program for prescription drugs.”
The agency, which currently receives up to 900 new generic-drug applications each year, said that generic drug applications are rising and user fees would be used to hire additional staff and improve generic-drug review systems.
The FDA proposes that generic-drug industry pay $299 million each year, including a $50 million fee to address pending abbreviated new-drug applications. As part of the recommendation, the agency said it would review 90% of abbreviated new-drug applications within 10 months of submission.
The proposed biosimilar user-fee program would address products approved under a new “abbreviated” approval process for biosimilar biological products.
Congress is required to reauthorize the current drug user-fee program every five years or it will expire.