FDA Considering Relaxing Rules against Scientists Receiving Money from Drug Companies
Thursday, July 28, 2011
Margaret Hamburg
The Food and Drug Administration (FDA) may relax conflict-of-interest rules that keep scientists with financial ties to the pharmaceutical and medical device industries from advising the regulatory body.
FDA Commissioner Margaret Hamburg acknowledged this week during a speech that industry and Republicans have complained about the slow pace of FDA review committees approving new drugs and devices. Critics contend that a 2008 policy restricting researchers paid by manufacturers from serving on advisory panels is curtailing feedback the FDA receives.
Twenty-three percent of the seats on the FDA’s advisory committees were vacant as of March.
Representatives of the device industry have complained about the lack of progress by the FDA’s Center for Devices and Radiological Health (CDRH), citing a high rate of turnover by reviewers. Compounding the trouble has been CDRH’s workload, which has increased by 26% since 2007.
Public interest groups were not pleased with Hamburg’s new position, fearing the undue influence of the industry that the FDA is supposed to be regulating.
-Noel Brinkerhoff
Conflict-of-Interest Rules May Be Relaxed in 2012, Hamburg Says (by Jeffrey Young, Bloomberg)
FDA Chief Defends Approval Process (by Emily Walker, MedPage Today)
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