21 mars, 2007 22:53
Drug Reviewers Face Stricter Rules on Industry Ties (Update2)
By Catherine Larkin
March 21 (Bloomberg) -- The U.S. Food and Drug Administration proposed stricter rules to limit the role of outside advisers with financial ties to the industries it regulates.
Advisory committee members with financial conflicts wouldn't be allowed to vote on recommendations to the regulatory agency under the proposal made public today. Panelists who received $50,000 or less in the previous year from a company with an interest in a matter before the committee could get waivers to participate without voting.
The new rules replace an array of policies used to select committees. Lawmakers and consumer groups have criticized the agency for allowing experts with industry ties to serve on the panels. Some called the proposal a step forward.
``I'm very happy about it,'' said Representative Maurice Hinchey, a New York Democrat, in a telephone interview today. ``This is something that has created a lot of danger by having people make decisions when they are likely to make them in their own financial interests rather than in the public interest.''
Committee members are paid to meet several times a year to recommend approval, rejection or further research on drugs, medical devices and biological products. The FDA usually follows the advice of its advisers, though it isn't required to do so.
`Significant Number'
The FDA doesn't know how many committee members would be affected by the new rules, though it probably would be a ``significant number,'' said Randall Lutter, the agency's acting deputy commissioner for policy, in a conference call.
Disqualifying financial ties under the new rules include stock, consulting fees, contracts, personal grants or other benefits received from a drugmaker whose medicine, or a competing product, is being considered by the committee. Research grants to a university employing an advisory panel member wouldn't be counted.
The FDA's oversight of drug safety has been under scrutiny since Merck & Co.'s Vioxx painkiller was withdrawn for cardiac risks in 2004 after five years on the market. Almost a third of the advisers on a panel that had recommended keeping the drug on the market had ties to drugmakers, according to a February 2005 analysis by the Center for Science in the Public Interest in Washington.
Panelists With Ties
More than a fourth of the panelists and consultants on FDA advisory panels had financial ties to a drugmaker whose product was being considered or to a competitor, according to a study by the Public Citizen consumer group that appeared in the April 26 edition of the Journal of the American Medical Association.
The FDA's Lutter said he's not aware of any cases in which advisers' financial ties ``unfairly or inappropriately'' affected the outcome in a committee.
Under the new policy, waivers may be given to panelists who received less than $50,000 if they have unique qualifications or if it's difficult to find experts without financial ties. The FDA commissioner could also allow committee members with interests exceeding $50,000 to participate ``in exceptional instances,'' Lutter said.
One consumer advocacy group said the waivers leave a ``giant loophole.''
``If the person with a conflict is important enough to include as an expert, they will certainly influence the vote,'' said Diana Zuckerman, president of the Washington-based National Research Center for Women & Families, in a statement.
Peter Lurie, deputy director of the health division of Public Citizen in Washington, disagreed. Barring an advisory panel member from voting is like pinning a scarlet letter on his lapel, he said.
``Everybody is going to know that guy is sitting there, but he can't vote,'' Lurie said in a telephone interview. ``It's going to, in effect, create tiers within the advisory committee: those who can vote and those who cannot.''
The public will have 60 days to comment on the FDA's proposal after it is published in the Federal Register on March 23.
To contact the reporter on this story: Catherine Larkin in Washington at clarkin4@bloomberg.net .
Last Updated: March 21, 2007 17:46 EDT
