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Washington, D.C. - Four months after the House approved a measure offered by Congressman Maurice Hinchey (D-NY) to end the Food and Drug Administration's (FDA) practice of allowing scientists and doctors with conflicts of interest to serve on its advisory panels, the House today approved a very watered-down compromised version of that measure that was worked out with Senate leaders. Hinchey sharply criticized the compromised language, which leading Senators advocated, because it creates significant loopholes that would permit the FDA to continue its practice of using conflicted experts on its advisory panels.
"We had a very real opportunity to finally put an end to the FDA's extremely troubling practice of consistently using doctors and scientists on its advisory panels who have direct conflicts of interest with the drugs, biologics, and devices on which they are supposed to give an unbiased opinion," Hinchey said. "While the final language makes it easier for the public to learn about advisory panel members with conflicts-of-interest, it does not address the heart of the issue, which is that these people don't belong on those advisory panels to begin with. As far as I am concerned, this battle is not over. During next year's appropriations process I will offer the same amendment that the House approved earlier this year to end all conflicts-of-interest on advisory panels and will work to gain support to ensure its final passage by both chambers."
Hinchey's amendment, which the House approved on June 8 by a margin of 218 to 210 as an amendment to the Agriculture, Rural Development, FDA, and Related Agencies Appropriations bill for Fiscal Year 2006, would have prevented 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 Senate approved a less strict conflicts of interest measure in September, which served as the foundation for the language that was finally agreed upon between House and Senate negotiators. The final, Senate-inspired compromised measure approved today makes a number of exceptions to the original Hinchey language. Specifically, the final amendment says:
· If the Health and Human Services (HHS) Secretary discloses the nature of the conflict of interest, and the nature of the waiver no later than 15 days prior to an advisory meeting, on the FDA website, then the FDA may proceed with the waiver.
· If the HHS Secretary or FDA discover a conflict of interest less than 15 days prior to the advisory committee meeting, the agency must make a disclosure as soon as possible, but in any event no later than the date of the meeting. In that case, the FDA may also proceed with the waiver.
· The Commissioner of Food and Drugs must make quarterly reports to the HHS Inspector General and the House and Senate Appropriations Committees on the efforts they have made to identify qualified people with minimal or no conflicts for appointment to advisory committees. If those reports aren't made, the FDA can't appoint new people.
"What this final version essentially says to the FDA is if you want to continue using doctors and scientists with conflicts of interest go right ahead, just let us know about it. That's unacceptable," Hinchey said. "The final version even says that the FDA needs to make public all members of its advisory panels with conflicts of interest 15 days in advance of that panel's meeting, but then goes onto say that if a conflict is discovered less than 15 days before the panel meets then that is fine as long as you let us know as soon as you find out. This is a do-nothing amendment and a lost opportunity for real progress."
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.
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. Another FDA advisory committee reviewing silicone breast implants included a scientist who had made a promotional video for a manufacturer of the implants. Additionally, three of 11 scientists on an advisory committee evaluating the link between antidepressants and suicide had been paid consultants for antidepressant manufacturers. This list goes on and on, including hearings on the abuse of Oxycontin.
The language that appeared in the Hinchey 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. Hinchey vowed to keep pursuing other legislative means to advance the full version of his FDAIA.
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