FDA says plan limits advisers' industry ties
Last Updated: 2007-03-22 13:06:59 -0400 (Reuters Health)
By Lisa Richwine
WASHINGTON (Reuters) - Doctors and scientists with industry ties exceeding $50,000 a year would be banned in most cases from sitting on influential Food and Drug Administration advisory committees under guidelines released on Wednesday.
The proposal is meant to tighten limits on which outside experts can serve on the panels and minimize conflicts of interest, FDA officials said.
"We think this will help us better fill advisory committees with the scientific expertise that we need in a manner that preserves public confidence in the integrity of our process," Randall Lutter, the FDA's acting deputy commissioner for policy, told reporters.
Financial links between the panel members and drug makers have come under scrutiny in recent years, prompting calls for the FDA to find advisers without industry connections.
The committees provide recommendations on whether new drugs or medical devices should be approved, as well as on other issues. The FDA is not required to follow the panels' advice but it usually does.
Under the agency's new plan, financial ties would include stock ownership or payments for research and consulting from companies that could be affected by a panel decision. An expert generally would be disqualified if the combined value exceeded $50,000 for the past 12 months, the FDA said.
For smaller sums, an expert may be allowed to take part in committee discussions but could not vote on recommendations.
The FDA commissioner could make an exception to the guidelines and allow participation. Lutter said he expected exemptions to be rare.
Rep. Maurice Hinchey, a New York Democrat who has pushed legislation to rid advisory panels of financial conflicts, welcomed the FDA move. "The leadership at the FDA is now acting in the public interest," he said in a statement.
But a consumer group said the $50,000 limit was too high because smaller amounts could sway an individual.
"A drug (representative) who takes someone to a memorable restaurant twice a year to chat about new drug developments 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," said Diana Zuckerman, president of the National Research Center for Women & Families.
The FDA will take public comments on the proposal for 60 days before issuing final guidelines.
