The US Food and Drug Administration (FDA) has set up a task force to help it become more open and accountable to the public.

The agency’s new Transparency Task Force, which is headed by Principal Deputy Commissioner Joshua Sharfstein, will hold a public meeting on June 24 to solicit recommendations on how the agency can make information on its activities and decisions more available, useful and understandable in a manner which, it says, is “compatible with the agency’s goal of protecting confidential information, as appropriate.” The panel will also accept public comments on its proposals until August 7 and a second public meeting will be held in the third quarter of the year.

Welcoming the Task Force, Health and Human Services Secretary Kathleen Sebelius said it “will give the American people a seat at the table and make the FDA more open and accountable,” while FDA Commissioner Margaret Hamburg noted that she has asked the panel to deliver, within six months, “recommendations to me for ways to make more information available and foster better understanding of decision-making.”

Such recommendations could include legislative or regulatory changes, “if appropriate,” according to the Task Force’s mandate, although legal experts warn of the immense challenges involved in amending the various laws which cover issues of confidentiality at the FDA. But secrecy has been at the heart of a number of drug safety scandals which have plagued the agency in recent years, and many critics believe that greatly increased transparency is the key to rescuing public confidence in the agency.

For example, Steven Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic in Ohio, wrote in Nature earlier this year that the FDA should cease regarding clinical trial data as proprietary and that it should provide access to all available information on safety and efficacy, whether gathered during approval for drugs or post-approval surveillance. “Secrecy is antithetical to both science and good government, but much of what the FDA knows about drugs, it never publicly discloses,” according to Dr Nissen who, with fellow long-time industry critic Dr Sharfstein, were initially regarded as joint favourites to take over the helm at the agency following the departure of Andrew von Eschenbach.

- In an article published in the New England Journal of Medicine (NEJM) on May 26, entitled The FDA as a Public Health Agency, Drs Hamburg and Sharfstein write: “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 and other guidance and explain its decision-making process to the public.”