PDUFA bill breezes through Senate, on way to president

The Senate wasted little time adding its stamp of approval on the compromise PDUFA legislation hammered out with the House, taking a quick step in the final march to the president's desk for final authorization. For the drug industry as a whole the spotlight is on a speedier review for a backlog of generic applications, while the public is being promised better oversight of overseas manufacturing facilities. But for drug developers the key aspects of the bill include easier access to regulators and accelerated reviews for more therapies.

News of the lopsided vote in favor of the PDUFA reauthorization--only four senators voted against it--quickly spurred a round of applause from industry groups, which played a central role in hammering out an agreement on the final bill and represented companies which will foot much of the bill to run the agency. 

In addition to promising more meetings and clearing a path for the next generation of targeted drugs that attack an unmet medical need, the legislation also continues to encourage the development of antibiotics, new therapies for rare diseases and pediatric drugs.

"FDASIA will foster timely interactive communication with sponsors during the drug development phase as a core agency activity to facilitate the conduct of efficient and effective drug development programs and help make safe and effective medicines available to Americans in a timely manner," noted BIO's Jim Greenwood in an approving statement. "Further, the enhanced accelerated approval pathway will help expedite the development of modern, targeted, and personalized therapies for patients suffering from serious and life-threatening diseases while preserving the FDA's robust standards for safety and effectiveness."

One of the key aspects of this new legislation is its reflection of the agency's evolving position on risks versus benefits. At the big BIO confab in Boston a few days ago FDA Commissioner Margaret Hamburg noted the change, saying: "There has been an apparent evolution in the thinking on safety and efficacy. We have seen a shift in the expectation that an FDA approval means that something is absolutely safe. Instead, safety is relative to benefits."

- read the story from The Washington Post
- here's the release from BIO