FDA Transparency Initiative Phase III Tranparency Report
On January 21, 2009, President Obama issued a Memorandum to the Heads of Executive Departments and Agencies on Transparency and Open Government. The Memorandum called for “creating an unprecedented level of openness in Government” and noted that “[o]peness will strengthen our democracy and promote efficiency and effectiveness in Government.” The Memorandum pledges that the Administration “will take appropriate action, consistent with law and policy, to disclose information rapidly in forms that the public can readily find and use” and instructs executive departments and agencies to “solicit public feedback to identify information of greatest use to the public.” On December 8, 2009, the Director of the Office of Management and Budget (OMB) issued the Open Government Directive.
Transparency is also a top priority for Secretary of Health and Human Services Kathleen Sebelius. Secretary Sebelius has formed a group that is dedicated to promoting transparency and openness at the U.S. Department of Health and Human Services (HHS) and is coordinating an overall HHS response to the Administration’s Open Government Directive.
Following the leadership of the President and the Secretary, the Commissioner of the U.S. Food and Drug Administration, Dr. Margaret A. Hamburg, launched the FDA’s Transparency Initiative in June 2009.
Commissioner Hamburg formed an internal task force to develop recommendations for enhancing transparency of FDA’s operations and decision-making processes. At the time of the announcement, she stated, “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.” Commissioner Hamburg expressed that “increasing our openness will help us more effectively implement our mission to promote and protect the public health.”
Commissioner Hamburg asked Dr. Joshua Sharfstein, the Principal Deputy Commissioner of the FDA, to chair FDA’s internal task force, whose members include five of the Agency’s center directors, the Chief Counsel, the Associate Commissioner for Regulatory Affairs, and the Chief Scientist. The Task Force was charged with submitting a written report to the Commissioner on the Task Force’s findings and recommendations.
To solicit public input on improving agency transparency, the Task Force held two public meetings, launched an online blog, held listening sessions with members of regulated industry, and opened a docket to which comments could be submitted.
At the first public meeting, the Task Force solicited comments on how the agency could improve transparency overall. Thirty five individuals provided comments during the meeting and 335 people attended in person or watched the live webcast of the eight hour session.
At the second public meeting, the Task Force solicited comments on three specific issues related to transparency at the agency: (1) early communication about emerging safety issues concerning FDA-regulated products, (2) disclosure of information about product applications that are abandoned (no work is being done or will be undertaken to have the application approved) or withdrawn by the applicant before approval, and (3) communication of agency decisions about pending product applications. Sixteen individuals participated in the groups convened to discuss each issue as well as during the open public session. One hundred seventy four people attended the meeting in person or watched the live webcast.
The online blog and the docket received over 1,500 comments. The blog, which is ongoing, has offered an opportunity for exchange about specific ideas for transparency at the agency.
The Task Force also solicited feedback from FDA’s Risk Communication Advisory Committee about communicating to the public about product recalls and emerging safety issues with FDA-regulated products.
Dr. Sharfstein attended a listening session, hosted by the White House Office of Science and Technology, to hear comments from the health care investor community on how transparency at FDA can foster investment in the life sciences and medical product innovation.
For this report, the Task Force reviewed the comments received about ways to improve transparency to regulated industry. The comments were used by the Task Force to inform the proposals in this report. The Task Force also identified ways to improve transparency that are reflected in this report.
Progress to Date and Future Plans
The Task Force is proceeding with the Transparency Initiative in three phases.
- Phase I: FDA Basics
- Phase II: Public Disclosure
- Phase III: Transparency to Regulated Industry
Phase 1: FDA Basics. The first phase is intended to provide the public with basic information about FDA and how the agency does its work. In early January 2010, FDA launched a web-based resource called FDA Basics. This resource now includes (1) 158 questions and answers about FDA and the products that the Agency regulates, (2) nine short videos that explain various agency activities, and (3) conversations with fourteen agency officials about the work of their Offices.
Visitors to FDA Basics can rate how helpful the information provided is and suggest additional questions for inclusion in FDA Basics. Feedback provided by the public is used to update the resource. Forty-four new questions have been added to the site, based in part on feedback provided by the public.
Each month, senior officials from FDA product centers and offices host online sessions about a specific topic and answer questions from the public about that topic. Each of these sessions is announced on the FDA Web site.
As of November 30, 2010, 957,008 visitors have viewed the FDA Basics site and left 8,781 comments.
Phase 2: Public disclosure. The second phase relates to FDA’s proactive disclosure of information the agency has in its possession, and how to make information about agency activities and decision-making more transparent, useful, and understandable to the public, while appropriately protecting confidential information. As required by the Administration’s Open Government Directive, the Task Force inventoried the information that is not currently available to the public and considered whether the public health would benefit from disclosure of some of this information.
On May 19, 2010, the Task Force released a report containing 21 draft proposals about expanding the disclosure of information by FDA while maintaining confidentiality for trade secrets and individually identifiable patient information. The Task Force solicited comment on the content of the proposals, as well as on which draft proposals should be given priority, for 60 days. Not all these proposals will necessarily be implemented. Some may require changes in law or regulation; some may require substantial amounts of resources.
The Task Force is reviewing the comments received and will recommend specific proposals to the Commissioner for consideration. The Task Force’s recommendations will consider feasibility and priority, considering other agency priorities that require resources.
Phase 3: Transparency to regulated industry. The Task Force held listening sessions and solicited comments about ways to improve transparency to regulated industry. The Task Force received comments from industry requesting additional clarity in standards and processes of the agency as well as additional transparency about the regulatory process.
The action items and proposals in this report address ways that FDA can become more transparent to regulated industry in order to foster a more efficient and cost-effective regulatory process. FDA will begin to implement the 19 action items outlined in this report in 2011. The Task Force is seeking public comment on the content of the five proposals in this report and may recommend specific proposals to Commissioner Hamburg for consideration.