FDA Transparency Task Force Unveils Draft Proposals on Openness

The U.S. Food and Drug Administration’s Transparency Task Force today released 21 draft proposals for public comment on public disclosure policies aimed at helping consumers, stakeholders and others understand how the agency operates and makes decisions.

The proposals, which will be published in the May 21 Federal Register are part of the second phase of the FDA’s Transparency Initiative launched in June 2009 by FDA Commissioner Margaret A. Hamburg. The task force was formed in response to the Obama administration’s commitment to achieve “an unprecedented level of openness in government.”

“Our goal is to facilitate transparency that promotes public health and innovation,” said Joshua Sharfstein, FDA principal deputy commissioner and chair of the Transparency Task Force. “These proposals reflect a careful balancing of the importance of transparency with the importance of protecting trade secrets and confidentiality.”

The proposals reflect the review of more than 1,500 public comments received by the FDA after two public meetings held by the task force and extensive consideration and discussion within the agency.

The FDA is seeking public comments on the proposals in the draft report for 60 days. The task force will consider the comments received, their feasibility, resource requirements, and the priority of each proposal to arrive at recommendations for Hamburg.