FDA Seeking More Transparency


In an effort to improve operations and ease consumer concerns, the U.S. Food and Drug Administration (FDA), the agency responsible for ensuring the safety of <"http://www.yourlawyer.com/practice_areas/defective_drugs">drugs

, <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">medical devices, and some foods, just announced that it is creating a task force to develop recommendations for enhancing the transparency of its operations and decision-making processes.

To support these efforts, the FDA issued a Federal Register notice announcing a June 24, 2009, public meeting to solicit recommendations on how it can make useful and understandable information on its activities and decisions more available. “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,” she added.

“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,” Dr. Hamburg noted.

The FDA announced that 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, the 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 Dr. Sharfstein. “I look forward to chairing this task force and reporting our findings to Commissioner Hamburg.”

The establishment of the task force follows President Obama’s January 21, 2009 memorandum directing executive agencies to find new ways of making information available to the public rapidly and in an easily accessible and user-friendly form. The FDA explained that 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;
• Submit a written report to the commissioner on the Transparency Task Force’s findings and recommendations.

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