It's about time the FDA pretended to have some ethics

It's about time the FDA pretended to have some ethics.---BBB

Posted on Mon, Jul. 24, 2006
FDA to revise rules for advisory panels
By Tony Pugh
McClatchy Newspapers

WASHINGTON - Stung by recent criticism that some of its advisory board members have undisclosed financial ties to drug makers, the U.S. Food and Drug Administration announced on Monday plans to strengthen and clarify its rules about who can sit on the consulting panels.

Composed of outside experts and scientists, advisory committees help guide the FDA on issues of safety and effectiveness of the prescription drugs and medical devices that the FDA regulates. The panels' recommendations on matters such as drug approvals have considerable influence in the industry and within the FDA.

The FDA can waive conflict-of-interest prohibitions and appoint committee members who may have financial relationships with commercial interests. However, critics say such appointments undermine public trust and could affect the impartiality of committee recommendations.

Congress is considering legislation to stop the FDA from appointing people with financial ties to industries or companies that are affected by the panels. A top FDA official argued Monday that it's nearly impossible to find qualified panel members without such ties and argued that ending the waivers would result in less-qualified advisory panels.

Instead, Dr. Scott Gottlieb, the FDA's deputy commissioner for medical and scientific affairs, outlined measures to help identify when a committee member has a conflict of interest. The measures also address when a conflict-of-interest waiver should be granted and what waiver information should be disclosed to the public, he told a discussion hosted by the Center for Science in the Public Interest, a consumer advocacy group.

Gottlieb said the FDA also will issue rules on when committee briefing materials can be made public, increase mailings to provide better advanced notice of committee activities, and streamline the appointment process for FDA drug-related committees.

In June, the House of Representatives passed a measure by Rep. Maurice Hinchey, D-N.Y., a frequent FDA critic, that would prevent the FDA from spending any money on waivers for advisory committees, which would end the practice of appointing scientists with financial ties to industry.

Similar concerns have been raised about advisory committees for the Environmental Protection Agency and the National Academies.

A separate study released Monday by the center found that 56 of the 320 professionals on 21 committees within the academies, or 18 percent, had financial ties to companies or industries in their committees' areas. The study also found at least 66 scientists "whose employment, long-term financial relationships, published writings, think-tank membership or courtroom testimony demonstrated pro-industry positions."