WASHINGTON -- The federal government proposed new rules yesterday that would make it tougher for scientists with industry ties to offer advice about approving new drugs and medical devices.
The Food and Drug Administration said that most scientists with $50,000 or more in stock, consulting fees or other financial links to companies should be barred from making recommendations to the agency about a related product. Scientists with smaller financial interests would be allowed to participate in agency advisory meetings but could not vote.
"This will enhance the public's confidence in the integrity of the process," said Randall Lutter, the FDA's acting deputy commissioner for policy.
The proposal is the government's latest attempt to reduce conflicts of interest among scientists who advise the FDA on whether to approve a new drug or medical device, change its warning label or request its removal from the market for safety reasons. The FDA usually follows the advice of panels of outside scientists.
Their meetings are designed to allow the government to draw on the unvarnished advice of the country's top experts.
But critics have attacked the independence of the advisory committees after a series of reports, in the Los Angeles Times and other publications, about conflicts involving committee members. The critics say these conflicts have led committees to endorse unsafe products, including the painkiller Vioxx, even after its manufacturer had removed the drug from the market because of an increased risk of heart attack.
A study published last year in The Journal of the American Medical Association, which looked at FDA advisory panel meetings over three years, found that more than half of the panel members had a conflict of interest at 22 percent of the meetings surveyed.
Dr. Peter Lurie, the study's lead author, said he doubted the new rules would keep many scientists from participating in the advisory panels as most have financial ties to industry of less than $50,000. But he said the rules were still likely to reduce the influence of scientists with industry connections and might encourage the FDA to step up its recruitment of scientists who have no industry ties at all.
"I'm not saying it's easy to find unconflicted experts with the amount of drug company money salted around universities these days, but I think this is a recognition that if you try harder, you can find unconflicted experts," said Lurie, deputy director of Public Citizen's Health Research Group, a consumer advocacy organization.
His study surveyed 221 meetings held by 16 advisory panels from 2001 to 2004. It found that at least one member had a conflict in 73 percent of the meetings.
Since 2000, the FDA has been screening its advisers for conflicts before meetings. Yet that effort only led to further criticism of industry taint, because the agency granted waivers that allowed many scientists to continue participating on the panels, citing the need for their expertise.
FDA officials said the new rules should put an end to those concerns by establishing clear standards for when and how scientists may participate. The agency could also decide to impose additional limits on the participation of experts who meet the new guidelines, if there is a perception of a serious conflict.
"We believe this approach is more stringent than the one it replaces," Lutter said.
He said that he didn't know precisely how many scientists would be disqualified from participation but that it was a "significant" number. Lurie's study found that 28 percent of the 1,860 scientists who served on the committees surveyed had financial interests greater than $50,000.
Peter Pitts, who oversaw advisory committees as an FDA associate commissioner from 2000 to 2002, expressed concern about the loss of so many distinguished experts from the panels.
"The agency should not have to depend on the almost best and the kind of brightest," said Pitts, director of the Center for Medicine in the Public Interest, an industry-supported group. Pitts derided the $50,000 limit as arbitrary and said the FDA should have decided instead to let its staff continue to pick scientists for the panels.
Rep. Maurice D. Hinchey, a Democrat from New York who has pushed legislation that would bar scientists with any conflict from serving on an advisory committee, praised the FDA's proposal as an "important step."
But Rep. Rosa DeLauro, who chairs the House subcommittee responsible for the FDA's budget, said she remains skeptical, given the agency's "recent track record of putting political and corporate interests above science." DeLauro, a Connecticut Democrat, said she was "concerned that a closer inspection of the plan's details will reveal the loopholes that would render it toothless."
Under the proposed rules, a range of compensation during the preceding 12 months would lead to dismissal from an advisory committee. But some industry spending, such as dinners, honorariums and grants companies give to universities to conduct research, would not normally count toward the $50,000 threshold.
The FDA is seeking public comment for the next 60 days.
The proposed rules fall short of an Institute of Medicine blue-ribbon panel's recommendation that a majority of advisory committee members be free of conflicts.
One example often cited by critics was the 2005 advisory committee vote in favor of allowing Vioxx to return to the market after its manufacturer voluntarily withdrew it. The committee also voted to keep another painkiller, Bextra, on the market. Ten of 32 panel members were later found to have had conflicts of interest, and their votes affected the outcome.
The FDA subsequently decided against allowing the sale of Vioxx and asked Bextra's maker to stop selling its drug.
Dr. Curt D. Furberg, a Wake Forest University professor of public health who served on that drug safety advisory committee, said meetings should be canceled if a majority of members have industry ties. Scientists with conflicts of interest shouldn't even be present during votes, he added.
"They can have an influence. They can be very persuasive. And some other members are more susceptible than others - they take into account what an authority would say," Furberg said.