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FDA launches transparency task force

By Diana Manos

The U.S. Food and Drug Administration will form a task force to develop recommendations for enhancing the transparency of the agency's operations and decision-making process.

The task force plan 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 a form that is easily accessible and user-friendly.

The FDA will hold a June 24 public meeting to solicit recommendations on the new task force.

"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."

FDA Commissioner Margaret A. Hamburg, MD, said, "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."

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

 According to Sharfstein, the 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.