Executive Summary: Public Disclosure Policy Report
Every day, the U.S. Food and Drug Administration (FDA) makes important health and safety decisions about foods, drugs, medical devices, cosmetics, and other widely used consumer products. Transparency in FDA’s activities and decision-making allows the public to better understand the Agency’s decisions, increasing credibility and promoting accountability. Transparency helps the Agency to more effectively protect and promote the public health.
In January 2009, President Obama issued a memorandum on Transparency and Open Government calling for an “unprecedented level of openness in Government” and directing the Director of the Office of Management and Budget (OMB) to issue an Open Government Directive instructing executive departments and agencies to take specific actions to implement the principles of transparent, collaborative, and participatory government. The Open Government Directive was issued in December. Under the leadership of Secretary Kathleen Sebelius, the U.S. Department of Health and Human Services has also prioritized transparency and openness. In June 2009, FDA Commissioner Dr. Margaret Hamburg launched FDA’s Transparency Initiative to implement these efforts at FDA.
The initiative is overseen by a Task Force representing key leaders of FDA. The internal task force is chaired by the Principal Deputy Commissioner of the FDA and includes five of the Agency’s center directors, the Chief Counsel, the Associate Commissioner of Regulatory Affairs, and the Chief Scientist. The Task Force is charged with submitting a written report to the Commissioner on the Task Force’s findings and recommendations.
Over the last eleven months, the Task Force has held two public meetings, launched an online blog, and opened a docket. The online blog and the docket have received 1,572 comments.
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 I: FDA Basics. The first phase is intended to provide the public with basic information about FDA and how the Agency does its work. This phase was unveiled in early January 2010 with the launch of a web-based resource called FDA Basics. The resource now includes (1) 126 questions and answers about FDA and the products that the Agency regulates, (2) nine short videos that explain various FDA activities, and (3) ten conversations with FDA officials about the work of their Offices. 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. Feedback provided by the public will be used to update this resource.
Phase II: Public Disclosure. The second phase relates to FDA’s policy on disclosure. The Task Force reviewed and considered all comments received from a range of stakeholders, many of which stated that FDA should disclose more of the information it has in its possession. The Task Force weighed the public interest in disclosure of additional information and the competitive interests implicated in disclosure, and used the comments from the public to inform the draft proposals for public comment in this report. The Task Force also identified ways to improve transparency that are reflected in this report.
In this report, the Task Force makes available for public comment 21 draft proposals for changes in policy related to the disclosure of information FDA has in its possession, while supporting the redaction of trade secrets and individually identifiable patient information from all documents proposed for disclosure. Other topics, on which FDA plans to make changes or on which the Task Force is not proposing policy changes at this time, are discussed in the “Other Areas of Public Comment” section of the report.
The Task Force is soliciting comments from the public on the draft proposals set forth in this report for 60 days. In addition to input on the content of the proposals and whether the Task Force has struck the right balance with respect to the draft proposals, FDA is seeking input on how the Agency should prioritize the proposals since FDA cannot implement all of the proposals at once. To develop the broadest slate of proposals, the Task Force did not, at this stage of the review, consider the feasibility of implementing the proposals. Based on this input, the Task Force 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. Some of the draft proposals may require extensive resources to implement, and some may require changes to regulations and possibly even legislation. As a result, the Task Force may ultimately recommend some, but not all, of the draft proposals for implementation.
Phase III: Transparency to Regulated Industry. The third phase of the Transparency Initiative will address ways FDA can become more transparent to regulated industry, in order to foster a more efficient and cost-effective regulatory process. The Task Force solicited comments from the public on this topic and draft recommendations from this phase are expected in the summer of 2010.