Grassley Secures Independent Review of FDA Approvals Based on Narrow Health Benefits

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GRASSLEY SECURES INDEPENDENT REVIEW OF FDA APPROVALS BASED ON NARROW HEALTH BENEFITS

Senator Chuck Grassley has asked for an independent assessment of how the Food and Drug Administration follows up on the effects of medicines that it approves based on narrowly defined benefits.

"The way things have turned out with drugs like Vytorin and Avandia raise enough questions that a review is warranted," Grassley said. "It's not clear if the FDA's own policies are being enforced internally, where the agency is supposed to require companies to perform follow-up studies. These policies are designed for patient safety."

Grassley's questions stem from a practice of the Food and Drug Administration to use goals called surrogate endpoints to study whether a particular drug achieves a certain benefit, such as lowering blood sugar in diabetics. Grassley said it's critically important that the agency adhere to its complementary policies that require drug-safety reviewers to follow up on drugs that are approved based on surrogate endpoints.

"The public relies on the FDA to keep it safe from dangerous drugs and not just stick to narrow judgments that may not incorporate overall health," Grassley said. The diabetes drug Avandia was approved because it lowered blood sugar but later found to increase the risk of heart attack, even though lower blood sugar is tied to lower heart attack risk.

The Government Accountability Office, which is the investigative arm of Congress, has agreed to conduct the review that Grassley requested in the letter posted below.

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