FDA SEEKS TO RESTRICT ITS EXPERTS’ TIES TO INDUSTRY

The Food and Drug Administration said Wednesday that it would bar outside medical experts with a financial interest in a manufacturer from voting on advisory panels assessing whether drugs or other products made by that company are safe and effective.

The proposed restrictions -- which would also apply to experts with ties to competing firms -- would significantly strengthen the FDA’s conflict-of-interest policy. One recent study suggests that more than one-fourth of FDA advisors may be prohibited from voting.

Industry supporters reacted cautiously to the announcement, saying it may limit the pool of qualified advisors the FDA can draw on. Consumer groups welcomed the move, although some said the proposed policy came with a considerable loophole.

That’s because the FDA would still permit experts with as much as $50,000 in financial ties to manufacturers to participate on panels as nonvoting advisors, giving them an opening to sway those voting.

FDA officials said the agency was tightening its rules as part of a broader effort to regain the public’s trust.

The withdrawal of the painkiller Vioxx and revelations about the suicide risks of antidepressants, along with other safety problems, have tarnished the FDA’s image. A September report from the Institute of Medicine of the National Academies called on the FDA to adopt stronger policies to minimize conflicts of interest among advisory panel members.

Critics have accused the agency of becoming too cozy with industry, and Congress is working on legislation to strengthen the FDA’s safety program.

Dozens of advisory committees guide much of the FDA’s decision-making on drugs and other products. Panel members -- usually prominent physicians and academic researchers -- vote on issues such as whether risky medications should be taken off the market, or what information should be provided to patients and doctors.

The FDA generally follows the recommendations of the panels, which also may include nonvoting members representing consumers and industry.

The financial ties to be examined under the guidelines include individual research grants, contracts and consulting fees, and investments in company stock, the FDA said. The agency will look at conflicts in the year before an advisory panel meets.

“The major achievement here is that you cannot vote on an advisory panel if you have a conflict of interest,” said Rep. Maurice D. Hinchey (D-N.Y.), who has been a sharp critic of the agency. “It’s not perfect, it’s not the end of the road -- but it is a step in the right direction.”

But Diana Zuckerman, president of the National Research Center for Women & Families, said a $50,000 exemption was too generous.

“Think of all the members of Congress who have gotten into trouble for much less,” she said. “People do crazy things for a lot less than $50,000 -- including people who earn a lot of money.”

The new restrictions will take effect after a 60-day period for public comment.

Current FDA rules automatically bar outside experts from taking part in an advisory panel meeting if their investments in a company likely to be affected by the decision exceed $100,000 or account for at least 15% of their net worth. Those with smaller investments may take part, but must file a disclosure form. Such conflicts are routinely noted in an FDA statement at the start of each meeting.

The current policy allows many experts with consulting contracts or other financial ties to manufacturers to fully participate in advisory committee meetings that involve products made by the specific firms.

A study published last year in the Journal of the American Medical Assn. found that 28% of committee members disclosed financial conflicts, but only 1% recused themselves from voting under current rules.

FDA officials said they could not reliably estimate how many current advisors would be disqualified under the new policy.

“One of the difficulties in trying to come up with that exact number is that it’s meeting-specific,” said Jill Hartzler Warner, an FDA lawyer. “You have to know [in advance] the meeting topic.” But officials said the agency would step up its efforts to recruit panel members without any conflicts.

The JAMA study found only a weak link between the participation of members with conflicts and the outcome of meetings. In a majority of cases, excluding the advisors with conflicts would have reduced the margin of approval for the drug that was being considered, but it would not have changed the final outcome.

“We think we have already done a good job” keeping FDA decisions free of any conflict, said Randall Lutter, acting deputy commissioner for policy. But he acknowledged that current conflict-of-interest rules had been unevenly applied across different advisory panels.

“We are committed to making the process even stronger and better-understood,” Lutter said. The new policy will increase “consistency, predictability and transparency,” he added.

But FDA officials would not say exactly how they arrived at the $50,000 figure as the threshold for financial conflicts.

Lutter said the threshold struck “an appropriate balance” between allowing the FDA to tap the expertise of academic scientists involved in industry-funded research and the need to reassure the public that the agency’s decision-making process was sound.

Independent experts close to the pharmaceutical industry said the new policy appeared to mark a change in direction for the agency.

“I am surprised the FDA is doing this,” said economist John E. Calfee of the American Enterprise Institute. “It’s a more activist FDA than I would have expected.”

Hinchey, the New York congressman, said newly confirmed FDA Commissioner Andrew C. von Eschenbach was making a concerted effort to respond to problems that critics had identified.

But Dr. Peter Lurie, author of last year’s JAMA study that revealed the extent of FDA conflicts, said financial interests were not the only source of potential bias. Doctors treating patients in clinical practice, he said, are often more likely to approve a drug than are medical researchers, who focus on statistics.

“Conflict-of-interest guidelines are important, but they don’t solve all the ills,” said Lurie, deputy director of Public Citizen’s Health Research Group, a consumer advocacy organization. “There’s an inordinate focus on clinicians and an insufficient focus on statisticians and epidemiologists, who tend to look at the data in a more dispassionate way. The clinicians always want more toys.”

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ricardo.alonso-zaldivar@latimes.com