FDA Mulls Putting Public's Health Above Companies' Trade Secrets

June 3, 2009

The Food and Drug Administration may stop honoring claims of trade secrecy by drug and medical companies when the drugs and devices they make are killing people. At least the FDA is thinking about it.

Under current policy at FDA and other agencies, companies' claims — that information they give to the government is proprietary and exempt from disclosure under FOIA and other laws — often go unchallenged.

In a June 1, 2009, story the New York Times reported:

"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."