Transparency Task Force - Progress to Date and Future Plans
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. The launch involved a media call and webinar with bloggers on FDA issues. This resource now includes (1) 126 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 ten 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. The Agency has received over 4,500 comments from the public since the launch of the FDA Basics resource. Feedback provided by the public is used to update the resource.
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.
Early reaction to FDA Basics has been positive. One blogger wrote, “[t]he initiative can go a long way toward educating the public about what FDA does—and how—and also provide industry with real-time answers to their daily challenges, ultimately improving product quality and patient safety.” Another blogger wrote, “[i]t is really well put together, clear and works quite well. . . . The site is not only supportive of transparency, but is highly instructive and educational.”
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.
The Task Force is soliciting comments on the draft proposals in this report. 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. FDA cannot implement all of the proposals at once so as part of the comment process, the Agency is seeking public input not only on the content of the proposals but on which draft proposals should be given priority, if implemented.
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 3: Transparency to regulated industry. The third phase will address ways that FDA can become more transparent to regulated industry, in order to foster a more efficient and cost-effective regulatory process. Draft proposals from this phase are expected in the summer of 2010.