FDA Seeks Comments on Making Enforcement Data More Accessible
The Food and Drug Administration is seeking comments on a report outlining eight draft proposals to make FDA’s compliance and enforcement data more accessible and user-friendly. They are part of FDA’s ongoing efforts to increase its transparency and part of its response to the President’s January 2011 Memorandum to federal agencies on making compliance information more publicly available and searchable online.1 Comments are due by December 2, 2011.
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Transparency Task Force Will Consider Comments, Make Recommendations
The Transparency Task Force, which developed the draft proposals, will review the comments received and recommend specific proposals to the Commissioner of Food and Drugs.
The following are highlights of the draft proposals:
Post More Info Similar to Inspection Observations, Warning Letter Compilations
FDA should explore whether posting additional data compilations or analysis, such as the Agency’s most common inspections observations or the warning letter compilations, both of which it already posts, would increase transparency or better inform the Agency’s own compliance efforts.
Better Integrate Compliance and Enforcement Data with Info on Regulated Firms
FDA should explore whether it can better integrate its compliance and enforcement data, as well as its other publicly available data on regulated firms, to make the data more user-friendly and easier to analyze.
Add Product or Violation-Specific Searches to Make Database Easier to Use
FDA should explore whether additional, or more specific search criteria (e.g., criteria that would enable individual product-specific or violation-specific searches), or more sophisticated search capability (e.g., predictive name searches) would make the inspections database more user-friendly and the data easier to analyze.
Improve Data Quality and Timeliness by Expediting Data Entry, Inspection Review
FDA should explore different ways to improve data quality and facilitate more timely data disclosure by expediting data entry, expediting inspection review and classification, and/or updating the data more frequently. Tools to improve data quality and speed data disclosure may include, for example, providing new technologies to investigators, introducing other process improvements, and/or implementing administrative incentives.
1In January 2011, the President issued Executive Order 13563 asking federal agencies to reassess existing regulations and to follow cost-saving, burden-reducing, and transparency principles for future regulations. (See ITT's Online Archives or 11011915 for summary.)
FDA report with draft proposals, dated 10/03/11, available here.
FDA press release, dated 10/03/11, available here.
FDA contact - Lisa Dwyer (301) 796--4709
(FR Pub 10/04/11)