Experts Urge Reform of FDA Clinical Trial Rules

In an interview, CDER's Dr. Galson agreed that there needs to be more innovation coming from pharmaceutical companies, but said that Congress must be careful to ensure that any additional regulatory authority doesn't hamper innovation. “There's a balancing act there,” he said.

Members of Congress also will have a chance to weigh in on FDA reform when the Prescription Drug User Fee Act (PDUFA) comes up for reauthorization in 2007. The PDUFA law, originally passed by Congress 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.