By Shankar Vedantam
Washington Post Staff Writer
Thursday, March 22, 2007
The Food and Drug Administration said yesterday that it plans to make extensive changes in how it selects medical experts to serve on its advisory panels after years of complaints that many of them have financial ties to the companies whose products they evaluate.
The proposal would eliminate many experts who serve on the panels despite having such financial conflicts, FDA officials said. Experts with limited conflicts of interest would be allowed to participate in the discussions but not to vote on the recommendations made to the agency.
The advisory committees play a central role in regulating drugs, medical devices and diagnostic tests. Their decisions largely determine what drugs and medical products can be marketed to Americans -- because the agency nearly always follows the panels' guidance.
In recent years, concern about the composition of the panels has reached a crescendo. The FDA and others have argued that overly strict rules might eliminate many -- in some cases all -- of the panel candidates with the needed expertise.
Yesterday, officials maintained that the agency's procedures have not been biased in favor of industry, but the new guidelines implicitly acknowledge what critics have long said -- that it is possible to find enough qualified experts who do not have ties to drug and device manufacturers.
The new rules come as Congress has become increasingly vocal about its displeasure with how the FDA is run and follow a stinging federal Institute of Medicine report last year, which called on the agency to address the concerns over conflicts of interest.
"This is one of several announcements the FDA has made in recent months whose timing suggests they are reactions both to the IOM report and the bills moving through Congress," said R. Alta Charo, a University of Wisconsin bioethicist who served on the institute's FDA review panel.
"The FDA is intent on getting out ahead of some of its critics as effectively as possible -- and that is a good thing," she said. Although the changes have not gone as far as urged -- capping the number of members with conflicts on any given panel -- Charo said: "The last thing I want to do is discourage incremental progress."
Under the new rules, any scientist or physician who has had $50,000 or more in financial ties to a company over the past 12 months, including stock or consulting arrangements, would be barred from panels evaluating that company's products. Those who have received less than $50,000 in the previous year might be allowed to participate in the discussion but could not vote.
In general, the FDA said, it will try to limit the participation of experts who are perceived to have a conflict of interest. If the FDA commissioner thinks an expert with financial conflicts is needed on a given panel, an exception can be made, but this will be rare, said Randall Lutter, the agency's acting deputy commissioner for policy.
Lutter and Jill Hartzler Warner, senior policy adviser and counselor in the FDA's Office of Policy and Planning, said it is not possible to say precisely how many experts who currently serve on advisory panels would be affected by the new rule, but they said it would have a significant impact. Agency officials did calculations to measure the impact of various cutoff points before deciding on $50,000.
"We are very interested in ensuring we have the best possible access to scientific experts," Lutter said. "At the same time, we seek to ensure we have the fullest public confidence in the integrity of our advisory committee process."
Lutter denied that the proposal, which will be open for public comment for 60 days, reflects FDA unease about the panels. Rather, he said, the step was being taken to ensure that the public's perception about the advisory panels' quality is in line with the agency's perception.
"We think we have done a very good job of ensuring the process deserves the respect of the American public," he said. "We are not aware of any instances where decisions have been unfairly or adversely affected by conflicts."
Lutter and Warner said the $50,000 figure would not apply to research grants made by pharmaceutical companies to universities where the scientists work, only to grants given directly to experts.
Diana Zuckerman, president of the advocacy group National Research Center for Women & Families, said the FDA guidelines will not do enough. Companies wield influence, she said, with sums far smaller than $50,000.
"A drug rep who takes someone to a memorable restaurant twice a year to chat about their research is spending relatively little money but is building a relationship that is likely to be more influential than giving a $2,000 honorarium -- perhaps even more than a $50,000 grant for a study funded by several companies," she said.
Zuckerman's center analyzed the votes of 11 FDA advisory committees from 1998 through 2005. She said the idea that experts with conflicts could serve on committees but not vote was not well thought out -- because nonvoting members play a substantial role in pushing the committees in one direction or another.
"Our study of advisory committee deliberations showed the collegial, consensus-building nature of these decisions," she said. "The votes are often unanimous because the group comes to a consensus, almost always to approve a product."