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Drug Agency May Reveal More Data on Actions

By GARDINER HARRIS The Obama administration plans to announce on Tuesday that it is setting up a task force within the agency to recommend ways to reveal more information about F.D.A. decisions, possibly including the disclosure of now secret data about drugs and devices under study. The task will be complicated. Agency confidentiality decisions are governed by several interconnected laws, including the Federal Trade Secrets Act. Changing them would "involve more than one Congressional committee and impact thousands and thousands of companies, and thus would be an extremely difficult legislative path," said Peter Barton Hutt, a former general counsel to the agency. "Many people have been harmed over the last decade because the F.D.A. has treated clinical trial results of drugs and devices as trade secrets," said Dr. Steven Nissen, a cardiologist at the Cleveland Clinic who has campaigned for the release of such information. To continue reading this interesting article by The New York Times, click here.

Full post as published by The Trade Secrets Vault on June 02, 2009 (boomark / email).