Monday, September 25, 2006

Panel: FDA hasn't learned from Vioxx

Two years after the withdrawal of the pain-killer Vioxx, the Food and Drug Administration still can't adequately track the safety of new drugs and respond quickly to problems, a panel of experts said Friday.

The Institute of Medicine said the FDA needs more money, people and power to ensure it maintains focus on the safety of drugs it regulates once they're on the market.

The institute proposed a series of steps to improve safety review, including boosting the FDA's budget.

It recommended the FDA review the safety of all new drugs five years after their introduction, making initial approval almost tentative and subject to withdrawal.

New drugs also would carry a symbol for two years alerting patients and doctors that uncertainties may remain about their risks and benefits. Advertising would be restricted during that period, if legally permissible, according to the report.

Courtesy AP

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