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Published on 9 December 2009

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FDA “yet to make Vioxx safety changes”


The Food and Drug Administration still has not 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 is 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.

“It is not yet clear if or when FDA’s decision-making process will be substantially improved as a result of its efforts,” according to the GAO report.

FDA officials declined to comment beyond the agency’s response included in the report.

Congressional investigators did note that the FDA is making progress on other safety initiatives, including:

Revamping the computer system used to track and sort reports of drug side effects.

Gathering more reports about possible drug safety issues from federal agencies and private medical systems.

Developing a system to resolve drug safety disagreements between staffers.

Copyright Press Association 2009



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