FDA reviewer calls for approvals overhaul

One of the FDA types who reviewed Avandia is calling for entirely new procedures for evaluating diabetes drugs. In an article for Diabetes Care, Bob Misbin says new diabetes treatments shouldn't be tested against placebo, but against existing drugs.

Noting that the "Avandia affair" got out of hand, Misbin says the FDA should set a high standard for new meds. It may not be able to require new drugs to be better than existing treatments, but it should do whatever's necessary to make sure drugs are safe.

Misbin wanted to require GlaxoSmithKline to conduct a post-marketing safety study of Avandia, but his bosses rejected that idea. Now, Misbin is saying that all diabetes drugs should be studied specifically for safety--in trials that can't exclude patients at risk for serious side effects--before they're approved.

- read the item at Pharmalot

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