Tuesday, June 05, 2007

Panel to Advise F.D.A. on Medical Risks

WASHINGTON, June 4 (Reuters) — The Food and Drug Administration said on Monday that it would appoint a panel of outside specialists to advise the agency on how to tell the public about the risks and benefits of medicines and medical devices.
The announcement came ahead of a Congressional hearing at which lawmakers are expected to ask why the agency did not warn patients about a possible heart risk with GlaxoSmithKline’s diabetes drug Avandia. Agency officials say other data conflicted with the finding.
The new advisory committee “will bring together a broad range of experts and views to help improve F.D.A.’s communication of the science-based information about product risks and benefits that the public needs to make informed decisions,” Randall Lutter, the agency’s acting deputy commissioner for policy, said in a statement.
Fifteen voting members will sit on the panel, which the agency said would include experts on risk communication, social marketing, health literacy, journalism, bioethics and other relevant fields. Consumers, patients and health professionals also may be appointed.

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