The FDA has announced the formation of a task force to develop recommendations for enhancing the transparency of the agency’s operations and decision-making process. To support the efforts of the task force, today the FDA issued a Federal Register notice announcing a June 24, 2009, public meeting to solicit recommendations on how the agency can make more available, useful and understandable information on its activities and decisions. “Our administration is committed to making government open and transparent,” said Health and Human Services Secretary Kathleen Sebelius. “The Transparency Task Force will give the American people a seat at the table and make the FDA more open and accountable.” “President Obama has pledged to strengthen our democracy by creating an unprecedented level of openness and public participation in government, and the FDA looks forward to participating in this process,” said FDA Commissioner Margaret A. Hamburg, M.D. “I have asked the Transparency Task Force to deliver recommendations to me for ways to make more information available and foster better understanding of decision-making.” The task force will be chaired by Principal Deputy Commissioner Joshua Sharfstein, M.D., and will include center directors, the associate commissioner for regulatory affairs, chief scientist, and the chief counsel. “Implementation of the Transparency Task Force’s recommendations should make agency actions and decisions, and their underlying processes and bases, more transparent to the public,” said Sharfstein. “I look forward to chairing this task force and reporting our findings to Commissioner Hamburg.” The Transparency Task Force will: Seek public input on issues related to transparency; Recommend ways that the agency can better explain its operations compatible with the appropriate protection of confidential information; Identify information the FDA should provide about specific agency operations and activities, including enforcement actions and product approvals; Identify problems and barriers, both internal and external, to providing useful and understandable information about FDA activities and decision-making to the public; Identify appropriate tools and new technologies for informing the public; Recommend changes to the FDA’s current operations, including internal policies and guidance, to improve the agency’s ability to provide information to the public in a timely and effective manner; Recommend legislative or regulatory changes, if appropriate, to improve the FDA’s ability to provide information to the public; and Submit a written report to the commissioner on the Transparency Task Force’s findings and recommendations. The establishment of the task force follows President Obama’s Jan. 21, 2009 memorandum directing executive agencies to find new ways of making information available to the public rapidly and in a form that is easily accessible and user-friendly.
