The U.S. Food and Drug Administration (FDA) is soliciting comments from interested persons on ways in which it can increase transparency between the FDA and regulated industry.
The request for electronic or written comments has a deadline of April 12, 2010.
The FDA regulates products responsible for about 25% of the gross national product of the U. S. and the industries responsible for these products.
The agency formed an internal Transparency Task Force in response to the Obama Administration’s commitment to achieve “an unprecedented level of openness in government.” The Task Force is developing recommendations for making information about FDA activities and decisions more useful, understandable, and readily available, while appropriately protecting confidential information.
On January 21, 2009, President Obama instructed executive departments and agencies to take appropriate action, consistent with law and policy, to disclose information to the public rapidly, and in a form that is easily accessible and user friendly. Executive departments and agencies have been charged with harnessing new technologies to make information about agency operations and decisions available online and readily available to the public. Executive departments and agencies have been asked to solicit public input to identify information of greatest use to the public.
Final phase
Based upon input received thus far, the Transparency Initiative has been divided into three phases.
The first phase, creating a web-based resource called “FDA Basics” to provide information on commonly misunderstood aspects of the agency, has been completed. The second phase, improving FDA’s disclosure of information to the public, is underway and the agency intends to issue draft proposals for public comment soon.
The request for comment for the third phase follows a series of listening sessions with members of regulated industry in January this year.
The Task Force held public meetings in June and November last year.
For this final phase, the FDA is particularly interested in comments from all interested parties on how the agency can make improvements in the following areas:
· Training and education for regulated industry about the FDA regulatory process in general and/or about specific new requirements.
· The guidance development process.
· Maintaining open channels of communication with industry routinely and during crises.
· Providing useful and timely answers to industry questions about specific regulatory issues.
