FDAnews Drug Daily Bulletin

CONGRESS APPROVES WEAKENED ADVISORY PANEL REFORM PLAN

Nov. 1, 2005
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Congress' recent acceptance of language requiring notification of an FDA advisory panel's conflicts of interest signals a defeat for lawmakers, including Rep. Maurice Hinchey (D-N.Y.), who sought to bar experts with such conflicts from participating in these panels. But Hinchey and other supporters are pledging to make another attempt to tighten the FDA's conflict-of-interest policies during next year's appropriations process.

The conference committee considering the FDA appropriations bill recently agreed to language that requires the agency to provide public notice of which advisory committee members have financial ties to drug or device companies 15 days before the panel's work begins. The language marks a win for Sen. Dick Durbin (D-Ill.), who had pushed for this approach.

The notification approach was a necessary compromise because lawmakers did not have the votes in conference to pass Hinchey's more-rigid proposal, Durbin spokesman Joe Shoemaker told FDAnews. Hinchey's amendment, which was passed by the House in June, would have prevented the FDA from using federal funds to grant waivers to advisory panel members that have financial ties to drug or device companies.

Forcing the FDA to provide better notification about conflicts of interest on its advisory panels will pressure the agency to drop committee members with significant conflicts, Shoemaker said. The administration bows to public pressure to a great degree and notification will intensify that, he added.

The final plan will also help to maintain a larger pool of qualified experts for advisory panels, Shoemaker said. Durbin and other lawmakers have argued that barring all experts with ties to industry would leave very few parties to participate in the panels.

But Hinchey and activist groups, including Public Citizen and the Center for Science in the Public Interest (CSPI), argue that the compromise only provides notice of a problem without addressing it. These groups are pledging to take steps to require panel members with such conflicts to recuse themselves, but they admit there is little chance of a legislative change this year.

"As far as I am concerned, this battle is not over," Hinchey said in a statement, which called the final language "a very watered-down version" of his original proposal and "creates significant loopholes" by allowing these parties to continue to be members of the panels. Hinchey pledged to offer his same amendment during next year's appropriations process.