FDA forms Transparency Task Force

The U.S. Food and Drug Administration (FDA) is forming an internal Transparency Task Force to develop recommendations for making useful and understandable information about FDA activities and decision making more readily available to the public in a timely manner and in a user-friendly format. The public will have an opportunity to provide comments to the task force about how FDA should explain what the agency is doing, the bases for the agency's decisions, and the processes used to make agency decisions.

The Task Force will take the following actions:

  • Seek public input on issues related to transparency by holding two public meetings;
  • Recommend ways that the agency can better explain its operations, activities, processes, and decision making, compatible with the agency's goal of appropriately protecting confidential information;
  • Identify information FDA should provide about specific agency operations, activities, processes, and decision making, including enforcement actions, recalls, 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, taking into consideration health literacy and the needs of special populations;
  • Identify appropriate tools and new technologies for informing the public;
  • Recommend changes to FDA's current operations (e.g., internal policies and procedures, standards, information formats, and guidance) to improve the agency's ability to provide such information to the public in a timely and effective manner;
  • Recommend legislative or regulatory changes, if appropriate, to improve FDA's ability to provide such information to the public; and
  • Submit a written report to the Commissioner on the Task Force's findings and recommendations.

Public Meetings:
Anyone may attend at no cost the respective public meetings. The first public meeting will be held on June 24, 2009 in Washington, D.C. The task force intends to schedule a follow-up public meeting in the fall, also in the Washington, D.C., area. Members of the public are also invited to submit written or electronic comments on issues related to transparency by August 7, 2009. For instructions on submitting comments, please visit www.regulations.gov.

The FDA is also exploring other electronic means for the public to provide comments and feedback on this topic. The FDA Transparency Blog, for example, provides opportunities to learn and provide feedback on what the FDA is doing, the basis for FDA's decisions, and the processes used to make agency decisions. The blog will run for the next six months (June through November 2009).

Source: FDA Transparency Task Force Homepage

Compiled by
Wolfgang Schmitt
On the behalf of the European Compliance Academy (ECA)

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