A Seat at the Table: FDA Sees Benefits in Transparency--June 2009

How does the FDA decide which drugs to approve and when to issue safety alerts? New leadership at the FDA would like to help the public get answers to those questions. A transparency task force has been set up to recommend the best ways to go about the task--a move US Health and Human Services Secretary Kathleen Sebelius hopes "will give the American people a seat at the table and make the FDA more open and accountable."

The effort may be coming not a moment too soon, as the FDA has faced increased scrutiny from Congress for both food and drug safety lapses, and nearly half of Americans surveyed in a recent Harris Interactive/Health Day poll believe the agency does a poor job of monitoring the safety and effectiveness of prescription drugs.

The task force will be chaired by FDA Deputy Commissioner Joshua Sharfstein, MD.

Writing in last week's issue of The New England Journal of Medicine, Sharfstein and FDA Commissioner Margaret Hamberg, MD, noted that, "transparency is a potent element of a successful strategy to enhance the work of the FDA and its credibility with the public. Whenever possible, the FDA should provide the data on which it bases its regulatory decisions."

Observers note, however, that confidentiality laws already on the books-including the Federal Trade Secrets Act--will need to be factored in as part of any effort to increase agency transparency.

The Transparency Task Force will hold its first meeting June 24 in Washington, DC, and has set up a blog (http://fdatransparencyblog.fda.gov/) to help solicit public comments on the effort.