Bob Misbin has been a medical reviewer at the FDA for a long time (we’re not sure how many years now), and so he’s seen a lot. And in the wake of the recent dust-up over Glaxo’s Avandia, he’s calling for new standards for approving diabetes drugs. In the upcoming issue of the Diabetes Care journal, Misbin writes that it would be best for experimental diabetes meds to be tested against existing drugs, instead of a placebo, Reuters reports.

“You can’t really evaluate a drug in a vacuum; you have to evaluate it in comparison to something,” Misbin, who reviewed the original Avandia application, tells Reuters. He adds that, since drugmakers have no incentives to test their pills against rival meds, the FDA should make this a requirement, given the effectiveness of existing diabetes treatments.

For those who may have missed the hoopla, a controversial meta-analysis published last spring in The New England Journal of Medicine found Avandia increased the risk of heart attacks by 43 percent. The FDA recently added a Black Box warning to that effect; the second for Avandia. Meanwhile, Glaxo suffered humiliating publicity when it became known a former exec threatened a critic. And Avandia sales, not surprisingly, are sliding.

“The FDA should not ignore the perceived shortcomings in the regulatory process that allowed the Avandia affair to get out of hand,” Misbin wrote.
He goes on to note that, although the FDA doesn’t have the authority to require a new drug be superior to existing treatments, the FDA “is not required to have proof that a new drug is unsafe to deny approval.” And he adds that the FDA should “set a high standard for drugs that offer no advantage over existing therapy.”

Misbin’s original advice to require Glaxo to conduct a post-marketing safety study as a condition for Avandia’s approval was not taken by his superiors. Not surprisingly, Misbin suggests that a safety trial should be required - before approval - of all diabetes drugs. While the FDA evaluates safety data as part of its clinical trials for approving a drug, Misbin is calling for a separate trial designed specifically to detect major safety problems. And that trial should not exclude patients at risk for serious adverse events. What do you think about this idea?

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In recent months, drugmakers have complained vocifersouly that the FDA is raising the bar for approving new drugs by, in effect, comparing experimental treatments with current therapy, Reuters writes. But a top FDA official told Reuters earlier this month that although there is a renewed focus on safety, the agency always has taken the safety records of comparable drugs into account when reviewing drugs.

Source: Reuters