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FDA Publishes Report on Transparency Initiatives for Compliance and Enforcement Data

Date: Feb 03, 2012

On February 1, 2012, the Food and Drug Administration (FDA) announced in the Federal Register the availability of a report entitled, "Food and Drug Administration Transparency Initiative: Exploratory Program to Increase Access to the Agency's Compliance and Enforcement Data." As detailed in the report, the Agency has adopted eight initiatives aimed at improving transparency for compliance and enforcement data. The initiatives were originally proposed by FDA for public comment in an October 2011 report, which is covered in detail in Keller and Heckman llp's October 4, 2011 article.

FDA received comments from the public on the transparency proposals from October 4, 2011 until December 2, 2011. Altogether, seventeen comments were received from manufacturers, trade associations, academia, animal rights advocates, and consumers. FDA's Transparency Task Force reviewed these comments, and recommended the implementation of all eight proposals. Below, we summarize the initiatives that FDA will explore to increase transparency of compliance and enforcement data:

Initiative 1: FDA will 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.

In its discussion of this initiative, FDA stated its commitment to establish automated and centralized processes for posting enforcement data, in lieu of the labor-intensive manual entry system it currently uses. Additionally, FDA will consider giving its investigators more technologically-advanced tools (e.g., tablet computers, bar code printers) to improve the timeliness and quality of the reports they generate.

Initiative 2: FDA will 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 it to remedy the errors more expeditiously.

FDA has agreed to explore ways to better alert the Agency to errors in its data, rather than the current option of contacting FDA by e-mail. The Agency also will consider establishing and sustaining a group of data stewards responsible for the ongoing correction of erroneous data.

Initiative 3: FDA will 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.

In addition to trying to draw more users to its compliance and enforcement webpages by providing accessible graphic presentations of data, the Agency also will investigate IT enhancements that would allow users to conduct independent analysis on source data.

Initiative 4: FDA will explore whether it can better integrate its compliance and enforcement data, as well as its other publically available data on regulated firms, to make the data more user-friendly.

FDA has agreed to look into the feasibility of centralizing its compliance and enforcement data, data terminology, analysis, reporting, and dissemination processes. FDA revealed that it is already considering a consolidated data repository that would enable users to generate compliance and enforcement data reports suited to their own needs.

Initiative 5: FDA will explore whether additional, or more specific search criteria, or more sophisticated search capability would make the inspections database more user-friendly and the data easier to analyze.

To the extent that resources allow, FDA will consider improving the search capability of public data portals. FDA plans to investigate the use of predictive search queries, automatic clustering of search results based on common characteristics of the information retrieved, and dynamic webpages that reflect users' saved preferences.

Initiative 6: FDA will 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.

FDA will assess the value and feasibility of providing further data compilations and analyses, in addition to exploring the option of providing direct access to data for those wanting to conduct their own analyses (Initiative 4).

Initiative 7: FDA will 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.

Building on the existing FDA Transparency Blog, FDA will investigate the usefulness of social media to communicate enforcement information to stakeholders and the general public.

Initiative 8: FDA will provide appropriate context for the compliance and enforcement data that it discloses, to help ensure that the data is not misinterpreted or misused.

FDA will explore the effects of re-characterizing potentially violative inspection findings. For example, the Agency will consider providing manufacturers' redacted responses to Warning Letters and it will consider providing disclaimers that Warning Letters on Good Manufacturing Practices (GMP) do not indicate that products are unsafe.

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In summary, FDA has adopted all eight initiatives that were proposed to improve the transparency of compliance and enforcement data. Yet, FDA has not provided any indication of how quickly or fully it will explore these initiatives, and it has not stated how many, if any, of the initiatives it plans to put into action. Stakeholders now know which ideas FDA will explore to improve transparency, but they do not have an indication of the likelihood that these initiatives will go into effect.

The full text of "Food and Drug Administration Transparency Initiative: Exploratory Program to Increase Access to the Agency's Compliance and Enforcement Data" is available on FDA's website.