The U.S. Food and Drug Administration plans to write new guidelines specifying when outside scientists and doctors serving on agency advisory panels should be disqualified because of conflicts of interest.
The FDA announced today that it is considering whether to make more information available to the public from advisory committee members’ financial disclosures. The panels make recommendations to the agency on allowing drugs and medical devices to go on the market.
The new guidelines will be designed to, “make sure that the current system is rigorous, consistent and transparent,” Scott Gottlieb, the FDA’s deputy commissioner for medical and scientific affairs, in a telephone interview. FDA decisions about who can serve on advisory committees probably won’t change significantly under the new guidelines, he said.
Members of Congress and public interest groups have criticized the FDA for appointing doctors and scientists who have financial or other relationships with the companies whose products they are asked to consider. The U.S. House has approved legislation that seeks to prevent the FDA from allowing those with conflicts to serve on advisory panels.
The FDA’s planned changes don’t go far enough to achieve, “unconflicted FDA leadership,” said Steven E. Nissen, president of the American College of Cardiology, in a panel discussion in Washington today sponsored by the Center for Science in the Public Interest. “The American people no longer trust the FDA to protect their health.”
Recruiting Panel Members
In a draft of his speech to the group today, Gottlieb said House legislation would create problems for the FDA. The measure might hamper the agency’s ability to, “put experience and expertise as the paramount criteria when recruiting members to serve on these committees,” according to the draft remarks.
“We issue waivers to some people who have what we deem to be relationships that, while significant enough to warrant disclosure, are not deemed to be the kind that, after properly disclosed, will affect their judgment or impartiality or outweigh the benefits of the contribution offered by their participation,” Gottlieb said in the draft.
The FDA staff makes decisions on whether conflicts of interest are serious enough to prevent people from serving on advisory committees. New guidelines would be used in making those decisions.
A study published in the April 26 Journal of the American Medical Association found that 28 percent of advisory panel members and consultants had a financial link to either a drug-maker whose product was being considered or a competitor. The most common ties were payments for consulting, grants or investments, according to the study by Public Citizen, a Washington-based group that is critical of the FDA’s oversight.
A February 2005 analysis by the Center for Science in the Public Interest found that 10 of 32 advisory panelists considering the safety of a class of pain medications similar to Merck & Co.’s withdrawn Vioxx had financial ties to the drugs’ makers.
Had those panelists been excluded, the advisory committee’s recommendation to leave the products on the market would have been reversed, according to the study by the Washington-based center, which focuses on nutrition and food safety.
The FDA needs more funding to replace fees that drug-makers pay to have their applications for approval reviewed because the payments make the agency dependent on the companies, said Nissen, who is chairman of cardiovascular medicine at the Cleveland Clinic.
Source: Bloomberg.com
To contact the reporter on this story:
Justin Blum in Washington at jblum4@bloomberg.net.
