Institute of Medicine (IOM) news release

The IOM released information last month that is worth another look! The IOM was asked by the FDA and the Department of Health and Human Services to convene a committee to examine the FDA process and make recommendations for improving said process. The recommendations of this committee were released on 9/22/06; copies of the full report, The Future of Drug Safety: Promoting and Protecting the Health of the Public can be purchased at the IOM website. Some of the recommendations from the committee include:

• Labeling requirements and advertising limits for new medications
• Clarified authority and additional enforcement tools for the agency
• Clarification of FDA's role in gathering and communicating additional information on marketed products' risks and benefits
• Mandatory registration of clinical trial results to facilitate public access to drug safety information
• An increased role for FDA's drug safety staff
• A large boost in funding and staffing for the agency

Additionally, the committee report recommends "that a substantial majority -- at least 60 percent -- of advisory committee members be free of significant financial involvement with companies whose interests may be affected by their deliberations. FDA should issue waivers for the other committee members very sparingly." Yes, Virginia, a zero tolerance policy on financial relationships with industry just isn't practical, is it?