A new internal task force at the Food and Drug Administration is seeking suggestions from employees, stakeholders and the public about how the agency can become more transparent, officials said Tuesday.
One topic of debate has been how the agency can balance manufacturers' proprietary concerns with the public's desire to know about clinical trial results for drugs not yet approved.
Some critics have viewed the FDA as "a black box that makes important decisions without explaining them," Commissioner Margaret Hamburg said at a news conference. "The agency can and should communicate with the public in a way that provides more clarity about the agency and its processes, not less."
The FDA might have a good explanation for a particular decision, "but you don't often hear that explanation very clearly," said Principal Deputy Commissioner Joshua Sharfstein, chair of the new task force.
The transparency task force will hold a public meeting June 24 in Washington, D.C., and another in the fall, Sharfstein said.
In the Federal Registry notice about the meeting, the FDA listed questions that it is specifically interested in pursuing, including:
*How can the agency better explain what it does?
*What should the FDA reveal about enforcement actions, product approvals and recalls?
*What tools should the agency use to provide more useful information?
*What, if any, legislative or regulatory changes are needed to make the FDA more transparent?
*What information should remain confidential?
Frequent FDA critic Sidney Wolfe, acting president of Public Citizen and director of the Health Research Group, says the move toward more transparency is a long time coming: Back in 1977, Norman Dorsen, a New York University constitutional law professor, questioned the FDA's longstanding practice of keeping data from premarket clinical trials confidential.
Dorsen recommended that Congress amend the Federal Food, Drug, and Cosmetic Act to say that safety and effectiveness data aren't trade secrets that must be kept confidential, Wolfe says.
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