FDA strives for more Transparency regarding GMP Compliance and Enforcement Data

The U.S Food and Drug Administration (FDA) released 8 new draft proposals in a report titled "Food and Drug Administration Transparency Initiative: Draft Proposals for Public Comment to Increase Transparency By Promoting Greater Access to the Agency's Compliance and Enforcement Data."

These draft proposals are focused on making FDA's compliance and enforcement data more accessible and user-friendly, and they are part of the ongoing efforts to increase the transparency of FDA's operations and decision-making.

In developing these draft proposals, FDA met with the Environmental Protection Agency (EPA) and the Department of Labor (DOL), both of which have well-developed and well-regarded enforcement data websites (www.epa-echo.gov/echo/). 

After consulting with EPA and DOL, FDA developed the 8 draft proposals it recently issued. The public may provide comments on the draft proposals until December 2, 2011 (please see the FDA press release below).

Draft Proposal 1: 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. To implement these types of tools effectively, FDA also should explore how frequently data should be updated in order for it to be useful to stakeholders.

Draft Proposal 2: Although FDA's inspections database webpage currently provides an e-mail address where stakeholders can submit questions about the database, FDA should explore whether:
(1) reporting buttons or other tools specifically focused on error reporting would allow stakeholders to more easily identify potential errors in compliance and enforcement data, and
(2) the Agency can implement procedures for investigating potential errors and correcting data, when appropriate, that would enable the Agency to remedy the errors more expeditiously.

Draft Proposal 3: FDA should explore how to present its compliance and enforcement data graphically and better utilize mobile web applications to draw more users to its compliance and enforcement webpages, and to encourage data analysis.

Draft Proposal 4: 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.

Draft Proposal 5: 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.

Draft Proposal 6: 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 about the Agency's own compliance.

Draft Proposal 7: FDA should 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 the public regarding its compliance and enforcement efforts.

Draft Proposal 8: FDA should provide appropriate context for the compliance and enforcement data that it discloses, to help ensure that the data is not misinterpreted or misused. Depending upon the circumstances, appropriate contextual information may include, for example:

  • Information regarding how frequently the data is updated,
  • Information regarding the reliability of the data,
  • Information regarding the average lapse of time between the inspection and the posting of inspection classification information,
  • Definitions of inspection classification types (i.e., Official Action Indicated (OAI), Voluntary Action Indicated (VAI), or No Action Indicated (NAI)), and
  • A statement explaining that the website's lack of information regarding a particular facility does not imply compliance or non-compliance (i.e., users should not infer that facilities that have not been inspected recently, or at all, are (or are not) in compliance with FDA's laws and regulations).

FDA Commissioner Dr. Margaret Hamburg launched FDA's Transparency Initiative in June 2009. The initiative is overseen by a Task Force that includes key leaders of FDA. The report issued today advances that initiative and is part of FDA's response to President Obama's Presidential Memorandum on Regulatory Compliance, which directed federal agencies to make compliance information more publicly available, easily accessible, downloadable and searchable online.

Source: FDA Press Release

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