Hospital Buyer

The FDA unveiled new guidelines on March 21st limiting participation in drug and device approval Advisory Committees by individuals who receive money from manufacturers. The rules were implemented by the FDA’s new Commissioner, Andrew von Eschenbach M.D., who commenced his post in December 2006.

The threshold was set at $50,000 and includes individuals who received money from manufacturers with products under review or from their competitors. The Commissioner can approve waivers, but the FDA anticipates that such will be rare. The rules will be finalized after the sixty day comment period expires.

Two instances that may have prompted the policy change were scandals involving two painkillers; Bextra and Vioxx. If these new guidelines had been in place, the Committee would have removed Bextra and not allowed Vioxx to return to the market. Ultimately, Bextra was removed and Vioxx did not reappear on the market, but some cite concerns about the process for review. Ten of 32 advisers who voted in favor of the drug’s approval received monies from pharmaceutical companies

The guidelines are generating a significant amount of expected press detailing both approval and dismay. See coverage in the New York Times.

Related stories:

• FDA Reviewers Question Drug Safety Process
• Manufacturers List Their Top Regulatory Issues
• FDA Rolls Out Plan for Better Postmarket Device Monitoring
• Observers Argue About Whether FDA Found Teeth in Drug Approval Process

March 22, 2007 Related topics: Ethics & Scandals, Standards, Quality, Safety, Errors, Pharmaceuticals