Following complaints from US Food and Drug Administration (FDA)
officials, US lawmakers appear likely to relax conflict-of-interest
rules for experts serving on FDA advisory committees reviewing new drugs
and devices. FDA officials, including Commissioner Margaret Hamburg,
have said publicly the rules intended to guard against undue influence
on FDA decisions have impeded the agency’s ability to find qualified
experts. Relaxation of the current rules may be included as part of the
pending reauthorization of the Prescription Drug User Fee Act.
The issue was raised during a recent US House committee hearing on the
reauthorization. A Reuters report quoted a congressional staff member
familiar with the matter, saying "Based on today's hearing and the
comments from Senators[Al] Franken [D-MN) and [Mike] Enzi [R-WY], I
think there is a good chance that this issue could end up in the final
FDA user fee bill."
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