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FDA Report Card 2015: Transparency


Whether through FOIA, correspondence, and/or conversation, it is often difficult to obtain desired clarity or relief from CDRH personnel. This is in contrast to the early performance of the FDA after enactment of the 1976 Amendments.

—Larry R. Pilot, attorney at law

For the most part, FDA strives to be transparent. My concern is that the agency seems to wait to say anything publicly until there's a complete consensus internally. That's not good, because it means that the agency's views are not expressed until they are carved in stone. I would much rather see a dynamic communication while FDA is still thinking about its approach.

Bradley Merrill Thompson, shareholder, Epstein Becker & Green

Transparency has its pros and con. On the pro side, sunshine is the best disinfectant. On the other hand, FDA is using company (i.e., proprietary) information to make decisions, though most of the info marked proprietary is really not. Nonetheless, everyone should be held responsible for their decisions, whether in a company or the FDA. Perhaps individual reviewers should have to explain their decisions publically, as part of a clearance or approval, just like U.S. Supreme Court justices publish their opinion, both for the majority as well as the minority. If it’s good enough for the U.S. Supreme Court, shouldn’t it be good enough for us?

Michael Drues, PhD, president, Vascular Sciences


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