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US advisers criticize FDA drug safety board
GAITHERSBURG, Maryland (Reuters) - Some outside advisers on Friday criticized a major part of the government's efforts to improve drug safety, saying a new oversight board needs independent voices and should consider meeting in public.
The Drug Safety Oversight Board was announced a year ago as a step to help regulators quickly respond to signs of unexpected side effects after a drug reaches the market.
Board members are senior U.S. Food and Drug Administration officials, plus experts from other government agencies. They meet periodically in private to discuss how to address emerging issues. Brief summaries are released to the public.
The board is separate from other FDA drug safety activities and an external advisory panel that provides input on drug risks when the agency requests it.
Dr. Peter Gross, the advisory panel chairman, praised the FDA as "incredibly competent" but said the board would benefit from outside views.
"You are setting yourself up for failure with this oversight board," Gross told FDA officials at a meeting of the advisory panel. "In this age of transparency, you decide to have a committee that's responsible, according to its name, for overall safety, and yet it meets in private. You don't have public representatives."
The board was established in the wake of Merck & Co. Inc.'s recall of arthritis drug Vioxx and other safety controversies that sparked criticism of the FDA's oversight.
The board is a good step that "addresses some of the perceived weaknesses," said Dr. Curt Furberg, an adviser from Wake Forest University School of Medicine in North Carolina.
Arthur Levin, director of the Center for Medical Consumers, said the board's name is misleading. "I don't think it's a drug safety board...The model is bad, the name is bad. Why can't there be an audience?"
FDA officials said the board was designed to be an internal management group, in part because officials must discuss confidential company information.
Adding nongovernment members would require a lengthy screening process for conflicts of interest that could delay action on important issues, they added.