Dec 9, 2009 8:10 AM by Associated Press

FDA yet to make safety changes 3 years after Vioxx scandal

Congressional investigators say the Food and Drug Administration has not followed through on changes suggested three years ago to better monitor drug safety.

The recommendations came after an embarrassing and dangerous episode with Vioxx. The FDA had approved the blockbuster pain drug in 1999, but pulled it from the market five years later after linking it to heart attack and stroke.

The Government Accountability Office report says agency officials have made some changes to drug oversight. But the bulk of its decision-making power is still in the hands of the scientists who approve new drugs, rather than those who monitor the side effects.

The FDA says it intends to give its surveillance office more responsibilities, but only after its nearly 200 employees gain the experience and resources needed to take on those tasks.


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