In an interview, CDER's Dr. Galson agreed that there needs to be more innovation coming from the pharmaceutical companies, but said that Congress must be careful to ensure that additional regulatory authority doesn't hamper innovation.
Congress will also have a chance to weigh in on FDA reform when the Prescription Drug User Fee Act (PDUFA) comes up for reauthorization in 2007. The law, originally passed in 1992, set up a system in which the pharmaceutical industry pays user fees to the FDA in exchange for the agency's agreeing to meet certain deadlines in the review of drug applications.