The FDA and drugmakers have hammered out a proposed deal for the future of PDUFA, and one change generating a lot of buzz is a 60-day filing date that would give regulators extra time to review developers' applications for new drugs.
An unnamed source told Reuters the idea of the filing-date period--after which the standard 10-month review deadline under PDUFA would kick in--would give the FDA time to dive into the complex applications. And in the long run, it might actually lead to shorter time frames for gaining approvals. Congress gets the final say on the proposal for reauthorizing PDUFA, which expires in September 2012. And now that the public comment period is open on the proposal, consumer advocates are likely to chime in with their criticisms of the millions of dollars in fees drugmakers pay the FDA to support the agency's budget and staffing for the reviews.
Both top agency and industry chiefs endorsed the proposed PDUFA pact. "We're starting to see a lot of innovative therapies come through as a result of all the investments in science over the last 30 years," CDER Director Janet Woodcock told the AP. "So this agreement will continue the review program that allows those products to move expeditiously through the regulatory process so they can reach the public in a timely way."
Jim Greenwood, BIO's president and chief executive, said the proposed PDUFA deal "will enhance the drug development and review process through increased transparency and scientific dialogue, advance regulatory science, and strengthen post-market surveillance. Most importantly, PDUFA V will provide patients and doctors with earlier access to breakthrough therapies."
- see BIO's release
- read the Reuters report
- see the AP's coverage