FDA Reform "Still Possible During This Congress"

Although drug approval times are down significantly, the US Food and Drug Administration is still the focus of much reform talk as the technological boom creates more pressure on the agency, which already regulates products worth 25 cents of every dollar spent in the USA, Marc Schneineson of Reed Smith Shaw and McClay has told a Food and Drug Law Institute meeting.

The FDA has taken an expansive regulatory posture while rulemaking has become less informal, he said; recently there has been more (but less consistent enforcement) and there is still a perceived review bottleneck. Historically, changes have been both internally-initiated and legislative, with bipartisan support, and efforts to make the FDA more user-friendly and streamline clinical research and review are not new. While time is running out for legislative change this session, he said, many regulations or guidances have been issued for comment, eg allowing the use of pilot biologics facilities, easing pre-approval of certain manufacturing changes and exempting devices from notification requirements.

Despite claims that FDA reform will not be taken up during the rest of the Congressional calendar, John Cohrssen, counsel to the House Commerce Committee, said he is still working on it. Committee chairman Bliley wants consensus and closure, but if this cannot be achieved he will bring the bill to the floor without it. In the Senate, issues on the timeframe and Senator Kennedy's concerns must be dealt with. Election politics do not help; as substantial consensus is needed, any sector involved could stop the progress.