Update letter from Dr. Sharfstein to Dr. Hamburg
December 29, 2009
Dear Commissioner Hamburg:
On behalf of the Transparency Task Force, I write to report our progress on the agency’s Transparency Initiative.
In one of your first acts as Commissioner, you announced the formation of an internal task force to develop recommendations for enhancing the transparency of the agency’s operations and decision-making processes. The Transparency Initiative was launched in response to the Obama Administration’s Open Government Initiative, which sets forth the Administration’s commitment to an “unprecedented level of openness in Government.”
With high-level representation from across the agency, the Task Force has solicited public input on improving agency transparency through a public docket, an online blog, and two public meetings, held in June and November 2009 respectively. The Transparency Task Force received hundreds of comments from various stakeholders—regulated industry, consumers, patients, health care providers, and others. As a result of these comments, which are accessible online, the Task Force has decided to proceed with its recommendations in three phases.
- The first phase of the Transparency Initiative is a web-based resource that will provide information about commonly misunderstood agency activities and frequently asked questions about FDA.
- The second phase of the Transparency Initiative 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 of the Transparency Initiative will address comments the
Task Force received about FDA’s transparency to regulated industry.
The Transparency Task Force will submit written reports to you, as appropriate, outlining its recommendations for the second and third phases of the Initiative. Some of the recommendations may require regulatory or statutory changes for implementation.
Progress on Phase I of the Transparency Initiative
As we approach implementation of Phase I of the Transparency Initiative, I want to give you more detailed information about this effort. Comments from the public first suggested the idea that FDA should provide basic information about the agency and how it does its work. As one person 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 . . .”
The FDA website currently contains significant amounts of information, but the content may be best understood by those who are familiar with the agency. Therefore, as the initial phase of the agency’s Transparency Initiative, the Task Force is launching a web-based resource to better explain to the public what the agency does. This resource will be accessible via a link on the FDA website.
The web-based resource, which we are calling FDA Basics, includes:
- Questions and answers about the agency and the products that the agency regulates
- Short videos that explain various agency activities
- Conversations with agency personnel about the work of their Office
On a periodic basis, different Centers and Offices in the agency will host online sessions during which the public can learn about a topic and ask questions to senior FDA officials about the topics. Each of these sessions will be announced on the FDA website, and by other methods as appropriate.
The launch of the FDA Basics resource is the start of a process that will make the agency more transparent by providing useful information to the public about agency activities and processes. We look forward to providing you with further reports about the progress of the Transparency Initiative.
Joshua M. Sharfstein, M.D.
Chair, Transparency Task Force