Details Of US FDA Reform Bills Now Released

Specifics of three new US House Republican Food and Drug Administration reform bills have been released by Representative James Greenwood, who is heading the reform effort. Rep Greenwood said he had been asked by Commerce Committee chairman Thomas Bliley to direct the House efforts, along with Representatives Joe Barton, Richard Burr and Scott Klug.

At a press conference detailing the three bills, Rep Greenwood said the relationship between American medical researchers and the FDA is an adversarial one that will be made collaborative by the reforms. The FDA today lacks a clear mission, he noted, and the bills give it one - to bring safe and effective products to the American consumer as efficiently as possible, and to encourage an environment that encourages rather than discourages the development of innovative new drugs and devices.

The reforms would require harmonization with international approval frameworks, he added, and allow accreditation by the FDA of certified third-party reviewers to expedite the approval process, under rigorous FDA oversight.