WASHINGTON Outside experts may not participate in federal advisory committee meetings on drugs and medical devices if they have more than a $50,000 financial interest in the companies governed by their decisions, according to new guidelines released Monday.
The Food and Drug Administration's guidance formalizes draft policy issued in March 2007. If an adviser's financial interest falls below $50,000, the FDA may grant them a waiver that allows them to participate, but will do so only if they find there is an essential need for the adviser's particular expertise.
"It's imperative that we seek advice from independent experts, and that we do so in a way that is public, open and transparent," Randall Lutter, a deputy FDA commissioner said Monday.
Advisory committee members often represent the world's leading authorities on a particular disease or condition. Drug and device makers often pay them lucrative consulting and speaking fees, but such financial arrangements also can lead to the appearance of a conflict of interest.
Last year, the FDA convened 48 meetings of advisory committees on topics ranging from the safety of diabetes medications to the evaluation of a new anticancer drugs for use in children.
Jill Hartzler Warner, a senior policy adviser at the FDA, said excluding people from committees who have some financial interest in the drug and device industry would make it extremely hard to find qualified advisers. "The industry relies on recognized experts. So do we," she said.
In 2006, researchers reviewed 221 meetings by 16 boards. They found that disclosure of conflicts of interest at advisory committee hearings was commonplace and rarely results in someone being barred from participating. The researchers, writing in the Journal of the American Medical Association found a "weak relationship" between the financial conflicts and voting behavior. However, excluding committee members from the vote would not have altered the outcome at any of the meetings studied.
Dr. Sidney Wolfe, one of the authors of that study, said the agency weakened proposed restrictions for those with a financial interest of less than $50,000. Previously, the FDA proposed allowing participation in meetings, but not a vote. Now, it will consider waivers that could allow them to vote. Still, he described the guidance as a step in the right direction.
"Over time, the percentage of people who have these (conflicts) will diminish," said Wolfe, director of Public Citizen's Health Research Group. "A lot of it will have to do with how much energy the FDA is willing to expend to find people who don't have a conflict of interest."
Diana Zuckerman, president of the National Research Center for Women & Families, said the $50,000 threshold was too high. She said she was concerned that too many advisers below the threshold would get waivers that allow them to vote.
"The FDA has consistently used a very low standard for granting waivers, and there is no evidence that this will change," she said.
Hartzler Warner said the new guidance is much stricter than past policy. She said the agency will limit the number of waivers it grants and it will insist that an adviser show the waiver is necessary to provide the committee with essential expertise.
Rep. Maurice Hinchey, D-N.Y., said the FDA's waiver policies had led to a broken system in which advisory panels were filled by experts with direct financial interests in the drugs and devices being reviewed.
"By making the standard for waivers more stringent and improving the voting system, the FDA is moving closer toward ensuring the only interest taken into account during these advisory panels is that of the American people," Hinchey said.
The $50,000 cap was one of several policy changes announced Monday. The agency also recommended that advisory board members vote all at one time, rather than one at a time.
"Simultaneous voting avoids voting momentum, in which some voters may be influenced, even subconsciously, by the votes of those who precede them," the agency said in a press release.
The agency also recommended that all votes be announced immediately at the meeting, and it said that all votes will be detailed on the FDA's Web site.
On the Net: