FDA takes step toward transparency

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With the creation of an internal task force at the FDA , the agency is seeking recommendations on how it can improve the transparency of its operations and decision-making process.

To support the efforts of the task force, the FDA plans to hold a public meeting on June 24 to solicit recommendations on how the agency can make more useful and understandable information on its activities and decisions available, according to a notice in the Federal Register published June 2.

Principal Deputy Commissioner Joshua Sharfstein, MD, will chair the task force, which will include center directors, the associate commissioner for regulatory affairs, chief scientist and the chief counsel.

The agency said the task force will not only seek public input on issues related to transparency but also will:

  • 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 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 its findings and recommendations.

The establishment of the task force follows President Barack Obama's Jan. 21 memorandum directing executive agencies to find new ways of making information available to the public rapidly and in an accessible and user-friendly manner.

The Obama Administration is "committed to making government open and transparent," said Health and Human Services (HHS) 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."