Is the FDA Evolving?

In an unprecedented show of transparency on the subject of how to manage concerns with the diabetes drug, Avandia, the FDA wound up appearing as something slightly less than the unchallenged, omnipotent ruler of all decisions regarding drug safety.

And that could be a good thing.

For the first time, the FDA let the public it serves take a peek at some of the agency’s inner workings, including disagreements in its scientist ranks about Avandia. It even publicly explained its decision for a change, and in the New England Journal of Medicine no less.

According to The New York Times:

“Some of the changes have been driven by people like Dr. Steven Nissen, a cardiologist at the Cleveland Clinic whose 2007 analysis of Avandia’s heart risks stunned doctors, patients and legislators, who asked why the F.D.A. had not done anything similar. When the agency revealed it had done an almost identical analysis a year earlier and found the same result, the controversy intensified.

‘You have these third-party analysts setting the agenda for the agency in ways that never happened before,’ said Daniel Carpenter, an F.D.A. historian at Harvard.

For the F.D.A., the Nissen analysis presented major challenges. It demonstrated that the agency no longer had a monopoly on the information needed to make drug and device safety decisions. Data from crucial clinical trials are increasingly being posted on public Web sites. And academics are using sophisticated techniques to test whether popular medicines are safe.”

By her remarks, it seems Dr. Janet Woodcock, the FDA’s drug center chief, is primarily concerned with the complexities of keeping the public informed about harmful side effects of FDA-approved medications.

“In the past, we would approve the drug after a couple of efficacy trials and that was it,” Woodcock said in an interview. “We didn’t know too much more about the drug. It was simpler.”

“It’s good for public health that we’re learning more, but it creates a more complex environment in which to regulate,” Dr. Woodcock said.

Dr. Woodcock's worries about complicating things aside, could it be the FDA has begun to evolve toward a more flexible, transparent organization?

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