The Food and Drug Administration on Monday announced new guidelines specifying when outside scientists and doctors serving on agency advisory panels should be disqualified because of conflicts of interest.
The FDA also said 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,” said Scott Gottlieb, the FDA’s deputy commissioner for medical and scientific affairs.
FDA decisions about who can serve on advisory committees probably will not change significantly under the new guidelines, he said.
The FDA has been criticized by members of Congress and public interest groups for appointing doctors and scientists who have financial or other relationships with firms whose products they must review.
The U.S. House of Representatives has approved legislation that seeks to prevent the FDA from allowing those with conflicts to serve on advisory panels.
Gottlieb said the House legislation would create problems for the FDA. In a draft of a speech given Monday Gottlieb said 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.”
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 drugmaker 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, another Washington-based group critical of the FDA, found that 10 of 32 advisory panelists considering the safety of a class of pain medications similar to Merck & Co.’s withdrawn Vioxx had financial ties to the drugs’ makers.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, the study found.
