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GAO: FDA yet to make safety changes post-Vioxx scandal

Submitted by on December 10, 2009 – 5:08 pmNo Comment | 28 views

GAO: FDA yet to make safety changes post-Vioxx scandal

The San Francisco Chronicle reports that the FDA still hasn’t restructured its staff to better monitor drug safety, more than three years after experts recommended key changes in the wake of the Vioxx scandal. That’s according to congressional investigators who found that the FDA has yet to follow through on changes suggested in 2006 to help the agency detect problems with drugs taken by millions of Americans.

Those recommendations came after the embarrassing and dangerous episode with Vioxx, a blockbuster pain drug the FDA approved in 1999, only to pull from the market in 2004 after linking it to heart attack and stroke. Agency officials have made some changes to drug oversight, according to a Government Accountability Office report, but the FDA continues to give the bulk of its decision-making power to scientists who approve new drugs, rather than those who monitor the side effects of drugs on the market.

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