FDA Offers New Ideas for Transparent Approach Toward Regulatory Enforcement

Posted 22 April 2014 | By Alexander Gaffney, RAC 

Here at Focus, we read regulatory enforcement documents like it's our job. To be fair, understanding what the US Food and Drug Administration (FDA) is doing and why is our job.

But despite having read through thousands of Warning Letters, recall notices, Form-483s and other enforcement notices, we can say one thing with relatively certainty: It's never been easy to track down everything FDA does.

Information: Hard to Find, Hard to Process

Some of its enforcement actions, like Form-483s for example, are often available only through Freedom of Information Act (FOIA) requests-a process so onerous entire industries have sprouted up around providing access to them. Other actions are available, but are buried deep within responses in FDA's Federal Register docket, databases, specific pages, hard-to-find responses to public officials or obscure announcements on its website.

And while it's still not easy to find many of these documents, FDA says the ease with which the public can keep track of its enforcement actions is improving.

In January 2011, an executive order issued by President Barack Obama ordered all executive agencies (of which FDA is one) to make compliance information "easily accessible, downloadable and searchable online to the extent feasible and permitted by law."

"Greater disclosure of regulatory compliance information fosters fair and consistent enforcement of important regulatory obligations," the order stated. "Such disclosure is a critical step in encouraging the public to hold the Government and regulated entities accountable."

The information is also of great use to regulatory professionals, who can read the tea leaves to determine which areas FDA is targeting for greater enforcement, the changing language it uses to cite noncompliant entities, and which areas may be ripe for further action. It's also important to ensure that regulatory enforcement isn't a "gotcha" game where regulators are enforcing regulations in novel ways unknown to industry.

Making Strides

FDA had been making a move toward further transparency since 2009 under its own Transparency Initiative, the agency noted. That program has already resulted in the launch of the agency's popular FDA Voiceblog, regular releases of performance metrics, and efforts to improve the information it releases on a regular basis.

For example, FDA proposed providing more public information about adverse event reports, its enforcement priorities, the results of inspections, import alerts, recalls and Warning and Untitled Letters.

If you've been keeping track of FDA's enforcement activities over the last three years, the fruits of these efforts have been obvious, as the public now has more of this information available to it than ever before.

But, as the agency explains in a report issued on 22 April 2014, more remains to be done. It recently met with representatives from the Environmental Protection Agency (EPA) and the Department of Labor (DOL) to "learn from and build upon" their experiences in advancing enforcement action transparency within their respective agencies.

FDA highlighted EPA's use of graphical representations of data as one major benefit, and DOL's use of aggregated datasets encompassing five different enforcement systems as another.

New Enforcement Policies Proposed

FDA now says it's working on eight new proposals modeled off DOL and EPA's successes. Those proposals will see it working to improve data quality, making enforcement data available more quickly, offering reporting buttons to report data errors, offer graphical representations of data, improving the searchability of data, offering enforcement insights and using social media to communicate its enforcement activities with the public.

A full list may be found below. Comments are due in 60 days.

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,39 both of which it already posts, would increase transparency or better inform the Agency's own compliance efforts

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).

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