FDA moves towards greater openness

Jun 3 2009

The Food and Drug Administration is taking steps towards greater openness.

The Associated Press reports that FDA Commissioner Margaret Hamburg "announced Tuesday she has created a task force to make recommendations on how the agency can release more information in such areas as drug evaluation and enforcement matters. She wants a report in six months." Deputy Commissioner Joshua Sharfstein will head the task force, which will represent all of the FDA's major divisions as well as its law enforcement branch. It will hold two public meetings with the first on June 24. "The FDA has long operated under strict confidentiality rules," the AP reports, and in opening up information, one sensitive issue will be what to do with unpublished clinical trial data from drug manufacturers. Despite such concerns, "Hamburg said she believes the need for secrecy may have been taken too far, and is harming the FDA's credibility within the medical community and among consumers" (Alonso-Zaldivar, 6/2).

The New York Times reports that for years the FDA "has withheld information about drugs and medical devices 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” and that “researchers have long complained that keeping such information secret can harm the public” (Harris, 6/1).

Meanwhile, USA Today notes that the new task force "is seeking suggestions from employees, stakeholders and the public about how the agency can become more transparent." It also listed several key questions the FDA is pursuing (Rubin, 6/3).