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FDA Mulls a New Experiment: Opening Up

More than two dozen speakers, including a dietary supplement expert and a breast cancer advocate, vented frustrations today about a longstanding lack of transparency at the U.S. Food and Drug Association. The unusual gathering, held in Washington, D.C., and webcast, is the most visible manifestation yet of FDA’s new effort to better communicate with the public and clarify its scientific process. In the spirit of openness, FDA also launched a “transparency blog” earlier this month.

The meeting was a chance for FDA’s varied stakeholders to describe their efforts at trying to wring information from the often secretive agency. Bray Patrick-Lake, a young woman who participated in a clinical trial of a cardiac device designed to ease migraines, described her and a fellow participant’s frustrations trying to communicate with FDA after problems arose in the trial. Several speakers urged FDA to release far more information about its communiques with companies, including discussions about medical therapies before they’re approved or rejected. The agency normally will not confirm or deny whether it’s considering an application for a new drug.

There’s also much confusion about how FDA weighs scientific evidence. Public meetings, for example, of FDA’s advisory committees, might reveal certain problems with a treatment, but FDA’s final action seems to contradict what’s brought up there. Diana Zuckerman of the National Research Center for Women and Families in Washington, D.C., points to silicone breast implants as one example. In that case, data presented at a public meeting several years ago cast the implants in a poor light; the product was later approved without a clear explanation, Zuckerman recalled. “We don’t have access to find out why” FDA made the decision it did.

Not surprisingly, industry representatives weren’t big fans of exposing every back-and-forth they have with FDA on a regular basis—mainly, they said, because of fears that it could tip off the competition. Just revealing a meeting between a company and a particular branch of FDA could be damaging, noted Andrew Emmett from the Biotechnology Industry Organization, if it suggests a company is considering expanding the uses for a particular drug or device.

The task force, which consists of senior FDA officials and is led by Principal Deputy Commissioner Joshua Sharfstein, will try to parse out how transparent it's willing to be. The group—which one speaker complained would do well to include those from outside the agency—will use the meeting, comments on the blog, and other input to submit recommendations to FDA’s newly installed chief Margaret Hamburg later this year.