FDA suggests new user-fee programs for drugmakers
The Food and Drug Administration sent Congress recommendations for two new user-fee programs for drugmakers that would help pay for quicker reviews of applications for generic and biosimilar drugs. The proposals were included with the FDA’S recommendations for the reauthorization of the Prescription Drug User Fee Act of 1992, which FDA Commissioner Dr. Margaret Hamburg said in a news release has “ensured a predictable, consistent and streamlined premarket program” for brand-name drugs. The proposal for a generic-drug user fee calls for the industry to pay $299 million each year, including a $50 million fee to address pending abbreviated new-drug applications. The agency in turn would review 90% of abbreviated new-drug applications within 10 months of submission. The FDA, which receives up to 900 new generic-drug applications each year, said applications are rising and user fees would be used to hire additional staff and improve genericdrug review systems. Ralph Neas, president and CEO of the Generic Pharmaceutical Association, said in a statement that the proposal is “an important landmark.” The proposed biosimilar user-fee program would address products approved under a new “abbreviated” approval process for those products. Congress must reauthorize the current drug user-fee program by September.