The proposals, to be published in the May 21, 2010, Federal Register, are part of the second phase of the FDA's Transparency Initiative launched last summer by FDA Commissioner Margaret A. Hamburg, M.D.
"Our goal is to facilitate transparency that promotes public health and innovation," said Joshua Sharfstein, M.D., 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."
Members of the media are invited to discuss the proposals and the efforts by the Task Force during a conference call with Dr. Sharfstein beginning at 1 p.m. EDT, May 19, 2010. Credentialed members of the media may call 888-790-3325. Use the passcode FDA. International callers dial 312-470-0197, no passcode.
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 Commissioner Hamburg.
During the last 11 months, the Task Force has held two public meetings, launched anonline blogand opened a docket. The first phase of the transparency initiative was completed in January 2010 with the launch of a web-based resource calledFDA Basics.
The FDA formed the Task Force in June 2009 in response to the Obama Administration's commitment to achieve "an unprecedented level of openness in Government." The Task Force is developing recommendations for making useful and understandable information about FDA activities and decision-making more readily available in a timely manner and in a user-friendly format, while appropriately protecting confidential information.
For more information check out theFDA Transparency Initiative Report and theFDA Transparency Task Force web page.