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FDA Transparency Initiative (March 2010)

by James E. Valentine                                            Printer Friendly PDF (188Kb)

 

On June 2, 2009, Health and Human Services (HHS) Secretary Kathleen Sebelius, and FDA Commissioner Margaret Hamburg, MD, announced the formation of the FDA Transparency Task Force to develop recommendations for enhancing the transparency of the agency’s operations and decision-making process. 

The Transparency Initiative was launched in response to the Open Government Initiative, which sets forth President Barack Obama’s commitment to an “unprecedented level of openness in government."i FDA Principal Deputy Commissioner Joshua Sharfstein, MD, chairs the Transparency Task Force, with membership consisting of high-level, agency-wide representation, including the Center Directors, Associate Commissioner for Regulatory Affairs, Chief Scientist, and Chief Counsel.

 

Soliciting public input on transparency

To assist in developing recommendations for the FDA Commissioner, the Transparency Task Force sought input from the public through a variety of methods, including public meetings, a Federal Register docket, and a blog. The task force sought general input, as well as answers to specific questions to aid in developing draft recommendations for improving transparency-related issues raised by the public. The draft recommendations could include ways FDA can better explain its internal processes, changes to the agency’s current operations, and legislative or recommendations in a written report submitted to the FDA Commissioner and to the public for comment.

Two public meetings on transparency were held in 2009. The first, held on June 24, solicited input from interested persons on ways for the agency to 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. The second public meeting on transparency, held on November 3, gathered detailed and in-depth comments on three specific issues:

 

(1) early communication about emerging safety issues concerning FDA-regulated products,

(2) disclosure of information about product applications that are abandoned or withdrawn by the applicant before approval, and

(3) communication of agency decisions about pending product applications.

The Federal Register docket was opened three times to allow written public feedback corresponding to the topics of the two public meetings.ii, iii, iv
Last, the FDA Transparency Blog provides opportunities for the public to provide feedback to the Task Force. Over time, the blog will pose new topics for discussion by the public, and the task force will take those comments into consideration when developing draft recommendations. The gathering of public input led the task force to develop a three-phase plan to make FDA actions, decisions, and underlying processes more transparent to the public, while still meeting the agency’s goal to protect confidential information appropriately.

 

Three-phase plan for the Transparency Initiative

Throughout the process of soliciting public input, the Transparency Task Force received hundreds of comments from various stakeholders, including health professionals, patients, regulated industry, and consumers. The comments are accessible at www.regulations.gov by searching the keywords “FDA Transparency Initiative.” Some comments also may be found on the FDA Transparency Blog. As a result of these comments, the task force decided to proceed with developing its draft recommendations in three phases.

The first phase of the Transparency Initiative is a Web-based resource that provides information about commonly misunderstood agency activities and frequently asked questions about FDA. The second phase relates to FDA’s disclosure of information the agency has in its possession. This phase will address the comments the task force received about how to make information about agency activities and decision making more transparent, useful, and understandable to the public, while appropriately protecting confidential information. The third phase will address the comments the task force received about FDA’s transparency to regulated industry. The draft recommendations for the second phase will be submitted to the FDA Commissioner and will be made available to the public around early April, and the third phase report will be completed next. The latter phases may require regulatory or statutory changes for implementation.

 

Phase I of the Transparency Initiative: FDA Basics

On December 29, 2009, the Transparency Task Force chair, FDA Principal Deputy Commissioner Sharfstein, described the rationale behind the first phase of the Transparency Initiative in written comments to FDA Commissioner Hamburg, stating that “[c]omments from the public suggested the idea that FDA should first provide basic information about the agency and how it does its work. As one public commenter stated, ‘I would like to see the FDA “faces behind the curtain” and what their jobs are. Who IS the FDA and HOW does it work? Make it simple…’”v

Principal Deputy Commissioner Sharfstein also noted in his comments that, although the FDA website contains significant amounts of information, it may be those who are most familiar with the agency that are able to best understand its content. To address this issue, the first phase of the Transparency Initiative established FDA Basics , a Web-based resource to better explain to the public what the agency does.

FDA Basics includes several components, including:

 

(1) questions and answers about FDA and the products that it regulates,

(2) short videos ex-plaining various FDA activities, and

(3) conversations with FDA personnel about the work of individual offices.

 

In addition, FDA Basics includes a webinar series in which, on a periodic basis, different FDA centers and offices will host online presentations that inform the public about a topic (e.g., access to investigational drugs, the inspection process) and allow webinar participants to ask questions of senior FDA officials about those topics.

 

How the health professional community can stay involved

The best way to stay involved and engaged with FDA is to stay informed. The agency will continue to update the webpage for the FDA Transparency Task Force  with relevant information on the task force’s progress and will modify the FDA Basics webpage on an ongoing basis to update and expand its educational content. This webpage also will list upcoming webinars about FDA topics.

The Transparency Task Force continues to solicit input from the public, especially through the FDA Transparency Blog. Health professionals are strongly encouraged to engage in this process by submitting feedback. Information on other opportunities to submit written comments will be announced in the Federal Register, on the FDA Transparency Task Force website, and on the blog. If you have questions or comments about a specific product or policy, please contact the FDA Health Professional Liaison Program within the Office of Special Health Issues by telephone at 301-827-4460 or by e-mail at oshi@fda.hhs.gov.

 

James E. Valentine is a Program Analyst in FDA’s Office of Special Health Issues and an MHS candidate at the Johns Hopkins Bloomberg School of Public Health. Valentine wishes to thank Afia Asamoah, JD, MPP, Special Assistant to the Principal Deputy Commissioner, for her review of this article.


 i Presidential Documents, Memorandum for the Heads of Executive Departments and Agencies on Transparency and Open Government (dated January 21, 2009). Federal Register 74(15), p. 4685 (January 26, 2009). Accessed at www.whitehouse.gov/open/.

 ii Food and Drug Administration Transparency Task Force; Public Meeting. Federal Register 74(105), p. 26712–13 (June 3, 2009).

 iii Food and Drug Administration Transparency Task Force; Reopening of Comment Period. Federal Register 74(158), p. 41711–12 (August 18, 2009).

 iv Food and Drug Administration Transparency Task Force; Public Meeting; Request for Comments. Federal Register 74(191), p. 51161-51163 (October 5, 2009). Sharfstein J. (2009, December 29).

 v Update on Phase I of the Transparency Initiative