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Inside the FDA

It wouldn't only be the medical product companies subject to greater disclosures of their business information--the FDA's procedures would also be opened up for scrutiny. In the past, notes Paul Kim, tension between the FDA's Office of New Drugs (OND) and Office of Surveillance of Epidemiology (OSE), which evaluate drug safety pre- and post-market, has surfaced.

"Sometimes public, unpleasant disagreements have come out and turned out to be intramural spats made public," says Kim, a partner at Foley Hoag. "So for the transparency initiative to really be 360 degrees, it has to not only disclose information about what happens to sponsors but also to really shed light on how the agency makes decisions. It's unclear how prepared the agency is for that level of transparency, and some sponsors would be very uncomfortable if the FDA made public its decision-making in or near real time. It'll be a true test for the agency to make that information truly public."

Associate Editor

Melissa Maleske

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