Lawmakers May Relax FDA Drug Conflict Rules


U.S. lawmakers likely will change the criteria for advisers reviewing new medicines next year because of complaints that the rules meant to prevent conflicts of interest make it harder to find real experts.

Congressional lawmakers may require the Food and Drug Administration to relax the rules that bar advisers from reviewing a drug if they have even indirect financial ties to related manufacturers, as part of an FDA funding bill.

Senators raised the issue during a hearing last week at the Health, Education, Labor and Pensions Committee.

“Based on today’s hearing and the comments from Senators Franken and Enzi, I think there is a good chance that this issue could end up in the final FDA user fee bill,” said a congressional staff member familiar with the matter. The staff member was referring to Mike Enzi, the top Republican on the committee and Al Franken, a Democratic committee member.

Fees from makers of drugs and medical devices provide more than a third of the FDA’s funding, which means that the bill often serves as a vehicle for broader FDA-related changes.

The agency often must delay panel meetings while it searches for experts without conflicts, lawmakers and FDA officials say. Top doctors are usually the ones drugmakers hire as speakers or consultants. […]

Advocates of stronger rules say the agency lacks the power to force full disclosure, and defines conflicts too narrowly. Members with past financial ties to a company are not considered under the rules, said Diana Zuckerman, president of the National Research Center for Women & Families.

“Those ties affect their voting, whether or not they currently are on the payroll,” she wrote in an email. “Research shows that even small gifts, such as an expensive meal or a $500 honorarium, will affect how a doctor or faculty member feels about a company and could affect how they vote.”

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