House narrowly passes amendment to FDA funding bill
On June 8th, the U.S. House narrowly passed an amendment to its FDA appropriations bill for the 2006 Fiscal year that would bar FDA from granting financial conflict-of-interest waivers to its Advisory Committtee members. The debate on the amendment was brief, but of enough interest to read, with Rep. Berry (D-Ark), the only registered pharmacist in the House, accusing the pharmaceutical industry of conspiring to rob the U.S. public at every opportunity. Those opposing the amendment did a poor job explaining why the amendment is a bad idea and why FDA has relied on such waivers frequently when appointing its committee members.
What they should have stated is that the waivers permit FDA to use the most qualified experts, those who know the drug or device under discussion the best. This is because the most knowledgable experts are those who participate in clinical trials with related drugs and devices before they reach the market. FDA typically does not allow experts who were actually paid by the sponsor whose drug/device is up for discussion to vote on an issue. Rather, FDA either makes them non-voting members or does not allow them to participate at all. The experts who vote are typically not paid by the relevant sponsor, except in cases where an entire drug class is being discussed and multiple sponsors are involved.
If waivers are not allowed (we’ll have to await Senate Appropriations Committee debate to see where the issue might be headed), FDA will be hard-pressed to staff its Advisory Committees with the most qualified experts. They will be forced to allow only those who are not paid by the sponsor or the sponsor’s competitors to participate, which leaves…basic scientists, epidemiologists, clinical practitioners, public advocates, and other academics, who mean well and certainly have something to contribute but who are not the only Advisors FDA must hear from at these forums in order to receive the expert guidance it requires.
