FDA Promotes Openness and Transparency to Public

What is the Food and Drug Administration (FDA) announcing?

FDA is announcing the formation of a Transparency Task Force to recommend ways to improve the openness and transparency of the agency’s information. This will help make useful and understandable information about FDA activities and decision making more readily available.

Why is FDA taking this action?

FDA believes that transparency is vital for both citizens and the agency. FDA is forming this task force to promote accountability and to provide the public with information about FDA activities and initiatives. This action is consistent with memoranda issued by President Obama on January 21, 2009. In the memorandum on Transparency and Open Government, the Administration pledged to take appropriate actions to disclose information to the public rapidly, and in a form that is easily accessible and user friendly. In addition, the Secretary of the U.S. Department of Health and Human Services (HHS) has established transparency as a critical priority for the Department.

Why is the federal government promoting transparency?

President Obama has pledged to strengthen our democracy by creating an unprecedented level of openness in government. The Administration believes that information maintained by the federal government is a national asset. Promoting transparency strengthens our democracy and promotes accountability and effectiveness in government. The Administration has pledged to take appropriate action, consistent with law and policy, to disclose information rapidly in forms that the public can readily find and use.

What will the Transparency Task Force do?

The task force will:

• Seek public input on issues related to transparency by holding two public meetings and establishing a means of obtaining public comment from citizens
• Recommend ways that FDA 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
• Identify appropriate tools and new technologies for informing the public
• Recommend changes to FDA’s current operations (for example, internal policies and procedures, standards, information formats, and guidance) to improve the agency’s ability to provide this information to the public in a timely and effective manner
• Recommend legislative or regulatory changes, if appropriate, to improve FDA’s ability to provide this information to the public
• Submit a written report to FDA Commissioner of Food and Drugs Margaret A. Hamburg, M.D., on the task force’s findings and recommendations

Carrying out the task force’s recommendations should make agency actions, decisions, and underlying processes more transparent to the public, while still meeting the agency’s goal of appropriately protecting confidential information. Further, carrying out the recommendations should also reduce the need for requests by the public for agency information under the Freedom of Information Act (FOIA).

Who will be on the Transparency Task Force?

Joshua M. Sharfstein, M.D., FDA’s principal deputy commissioner, will chair the Transparency Task Force. The task force members, who will provide high-level, agency-wide representation, include FDA’s

• Center Directors
• Associate Commissioner for Regulatory Affairs
• Chief Scientist
• Chief Counsel

How will the Transparency Task Force affect the public?

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 submit a written report to the FDA Commissioner approximately six months after the task force is convened, and the Commissioner will report back and confer with the Secretary of HHS on the recommendations. Carrying out the recommendations will make 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.

Can anyone attend the public meetings?

Anyone may attend at no cost, but seating is limited. FDA is asking those who want to attend or make an oral presentation at the meeting to register electronically at Transparency.Meeting@fda.hhs.gov by close of business on June 17, 2009.

Registration on the day of the meeting will be provided if space is available beginning at 7:30 a.m. on a first-come, first-served basis. 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. FDA is also exploring other electronic means for the public to provide comments and feedback on this topic.

When and where will the public meetings be held?

The first public meeting will be held June 24, 2009, from 8 a.m. to 5 p.m. at the National Transportation Safety Board (NTSB) Conference Center, 429 L’Enfant Plaza, S.W., Washington, D.C. 20594. The task force intends to schedule a follow-up public meeting in the fall, also in the Washington, D.C., area.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

Date Posted: June 2, 2009

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