Proposal Calls for More Transparency for FDA Enforcement Data

Oct. 11, 2011 – The FDA is seeking to provide more complete compliance and enforcement data to the public and regulated industry, according to a document issued last week by the agency’s Transparency Task Force.

The document, “Draft Proposals for Public Comment to Increase Transparency by Promoting Greater Access to the Agency’s Compliance and Enforcement Data” includes recommendations “focused on making FDA’s compliance

and enforcement data more accessible and user-friendly, and they are part of our ongoing efforts to increase the transparency of FDA’s operations and decision-making,” the agency stated in a press release.

Among the proposals is a recommendation that the FDA “explore ways to better utilize social media, such as Facebook and Twitter, as well as Agency-sponsored webinars and automatic e-mail notifications,” to better communicate with its constituents (Draft Proposal 7).

The task force also calls for the agency to look for ways to better present its compliance and enforcement data graphically and better utilize mobile Web applications to draw more users to its compliance and enforcement Web pages (Draft Proposal 3). The document states that the agency already has implemented this proposal “by developing a centralized webpage where stakeholders can easily access” press releases regarding the filing and resolution of enforcement actions filed by the Department of Justice on the FDA”s behalf.

The FDA also states it has placed “a number of enforcement-related datasets on the website.” Further, the agency has launched a redesigned Web page and a phone app to permit the public to search easily for enforcement information.

Other proposals direct the FDA to focus on more timely data disclosure, develop user interfaces, integrate compliance and enforcement data, determine whether additional data compilations or analysis would “increase transparency or better inform the Agency’s own compliance efforts,” and decide if providing appropriate context for the noncompliance and enforcement data that it discloses might avoid misinterpretation or misuse of those data.

Comments on the draft proposals will be accepted until Dec. 2 via!docketDetail;dct=FR%2BPR%2BN%2BO%2BSR;rpp=10;po=0;D=FDA-2009-N-0247. The FDA Commissioner will determine whether to adopt any of the proposals by Jan. 31, 2012.

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