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Archive for Saturday, September 23, 2006

New steps needed to ensure drug safety

September 23, 2006

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— Two years after the withdrawal of the painkiller Vioxx, federal health regulators still lack the resources necessary to track the safety of new drugs and respond quickly to any problems that might crop up, a panel of experts said Friday.

The Institute of Medicine experts said the Food and Drug Administration needs more money, people and power to ensure the safety of the drugs it regulates. Also needed are labeling and advertising restrictions on newly approved drugs that would stress the uncertainties that remain about their safety, the Institute of Medicine said in "The Future of Drug Safety," a report issued Friday.

The institute said there was an appearance of a crisis in drug safety but did not determine whether one actually exists. It did paint the picture of a lopsided agency, with less-than-adequate amounts of time and money being spent on drugs' safety once people begin using them in great numbers.

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