GAO to study FDA's post-approval review process

Prompted by calls from Sen. Charles Grassley, the Government Accountability office has set plans to review the current method by which the FDA approves some drugs, including challenged medications like diabetes drugs Avandia and cholesterol drug Vytorin. Right now, the agency bases some approvals on "biomarkers," measurable responses in patients which are believed to predict other outcomes. For example, Avandia was approved because it lowered blood sugar, which was believed to lower heart attack risk, a much quicker route than waiting years to see if patients actually had the heart attacks. Since then, however, research has suggested that Avandia actually raises such risks.

Advocates say using biomarkers is appropriate for several reasons. Among other things, they say the longer trials needed to actually find events like heart attacks might jeopardize patients, as some would have to take a placebo for long stretches. Meanwhile, some critics say using biomarkers isn't necessarily the problem. They contend that the real concern is that the FDA doesn't require follow-up studies which would investigate whether drugs like Avandia and Vytorin delivered on their promised benefits.

To learn more about this issue:
- read this Associated Press piece [1]

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