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House Approves Bill to End Conflicts of Interest on FDA Panels

Source: Congressman Maurice Hinchey
Published: June 09, 2005

The U.S. House of Representatives approved Wednesday a bill that would put an end to conflicts of interest on Food and Drug Administration advisory panels.

The amendment, introduced by Congressman Maurice Hinchey (D-NY), helps ensure the scientists and doctors recommending drug approvals have no financial stake in the matter.

�Passage of this amendment to end conflicts-of-interest is a victory for public health and restores integrity and confidence in the FDA's advisory committees,� Hinchey said. �Advisory committees are critical parts of FDA's regulatory scheme and should be free of any direct conflicts-of-interest.�

The FDA relies on advisory committees composed of outside scientists to guide the agency on safety and effectiveness of drugs and medical devices. However, the FDA routinely waives conflict-of-interest prohibitions and appoints scientists with such conflicts to serve on these panels.

�These appointments undermine the objectivity of this outside advice and bias the committee's recommendations, which are reached by a vote of the panel members,� Hinchey stated.

For example, 10 of 32 scientists on FDA�s Cox-2 advisory panel had ties to manufacturers of the drugs. Had their votes been eliminated, two of the three drugs in that class would have been voted down by the panel, instead of receiving narrow support.

In a statement, the FDA said: �After conducting a review of the potential conflicts of interest for all of the members on the advisory committee examining COX-2 inhibitors, conflicts of interest were found. However, these conflicts were not deemed to be of sufficient magnitude to outweigh the need for the members� and consultants� expertise for this meeting.�

The amendment prevents the FDA from spending any money on waivers for advisory committees, effectively ending the practice of including scientists on advisory panels with ties to the drugs and devices at question.

The language in the amendment is a component of the congressman's FDA Improvement Act (FDAIA), which is a sweeping reform bill that would end the financial link and inappropriately close relationship between the drug industry and the FDA, eliminate conflicts-of-interest on FDA advisory committees, and vastly improve the agency's post-market drug safety operations.

Read Full Story at Congressman Maurice Hinchey

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