Wednesday, June 3, 2009

Drug Agency May Reveal More Data on Actions

For years, the Food and Drug Administration has withheld information about transparency from the public when their makers cite trade secrecy — even in cases where the agency suspects that the products are causing serious illness or death.

Now the new leadership at the F.D.A. may change that. 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.

Still, the goal is to open up a system in which the agency failed to inform the public that a widely prescribed heartburn drug was especially toxic to babies; that a diabetes medicine and a painkiller increased heart attack risks; and that antidepressants increased suicidal thoughts and behavior in children and teenagers.