June 4, 2007 / 5:08 PM / 12 years ago

US FDA panel will advise on communicating risks

WASHINGTON, June 4 (Reuters) - A new panel of outside experts will advise the U.S. Food and Drug Administration on how to tell the public about the risks and benefits of medicines and medical devices, the agency said on Monday.

The announcement came ahead of a congressional hearing at which lawmakers are expected to ask why the FDA did not warn patients about a possible heart risk with GlaxoSmithKline Plc’s (GSK.L) (GSK.N) 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 FDA’s communication of the science-based information about product risks and benefits that the public needs to make informed decisions,” Randall Lutter, FDA’s acting deputy commissioner for policy, said in a statement.

Fifteen voting members will sit on the panel. The FDA said they would include experts on risk communication, social marketing, health literacy, journalism, bioethics and other relevant fields.

Consumers, patients, caregivers and health professionals also may be appointed to the committee, the FDA said.

Advisory panels provide recommendations to the agency. The FDA is not required to follow their advice but usually does.

The agency said it acted promptly to establish the new panel after a September 2006 Institute of Medicine report recommended it and other steps to improve drug safety.

The FDA said it expanded the scope of the panel to include all products the agency regulates, not just medical ones. The agency oversees about one-quarter of the U.S. economy, including prescription and over-the-counter drugs, medical devices, dietary supplements and most foods.

The agency’s drug safety monitoring has come under fire in recent years. Critics said officials were slow to respond to problems with Merck & Co. Inc.’s (MRK.N) arthritis pill Vioxx, which the company withdrew in September 2004, and other medicines.

New questions about the FDA’s oversight arose last month when a study published by the New England Journal of Medicine said Avandia raised heart-attack risk by 43 percent.

After the study was released, the FDA said its preliminary analysis put the heightened risk around 40 percent, while Glaxo said its estimate was 30 percent. Both the FDA and Glaxo, however, said other data gave conflicting evidence.

On Wednesday, a House of Representatives committee is set to question FDA Commissioner Andrew von Eschenbach and Glaxo’s research and development chairman about their handling of Avandia.

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