FDA releases 8 transparency proposals

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The FDA is seeking public comment on eight draft proposals aimed at increasing access to compliance and enforcement data. The proposals were made in compliance with President Barack Obama’s Memorandum on Regulatory Compliance, which requires federal agencies to make publicly available compliance information easily accessible, downloadable and searchable online.

The proposals were released after consultation with the Environmental Protection Agency (EPA) and the Department of Labor (DOL), both of which maintain robust data websites, according to an Oct. 2 FDA announcement.

The FDA proposed:

  • Exploring different ways to improve data quality and facilitate more timely data disclosure by expediting entry, inspection review and classification, and updating data more frequently. The FDA plans to look into technological tools to help facilitate this.
  • Implementing reporting buttons or other tools specifically focused on error reporting and establishing procedures for investigating potential errors and correcting data.
  • Exploring how to present compliance and enforcement data graphically to better utilize mobile web applications to encourage data analysis.
  • Exploring whether it can better integrate data to make it user-friendly and easier to analyze.
  • Considering additional or more specific search criteria, as well as capability, to make the inspections database user-friendly.
  • Evaluating posting additional data compilations or analysis to increase transparency into the agency’s compliance efforts.
  • Better utilization of social media.
  • Providing appropriate context for the data that it discloses.

The report also includes status updates of previous FDA data initiatives, and summarizes the EPA and DOL efforts at increasing public access to data. The full report can be found here.

The FDA will accept public comment on the proposals until Dec. 2 here.