FDA Report Details Public Availability of Regulatory Compliance Data


I recently stumbled upon a Federal Drug Administration report issued in response to President Obama’s Regulatory Compliance Memo. The May 2011 report chronicles the agency’s transparency efforts since 2009 as well as outlines goals for making additional data available.

A look into the FDA’s website found mixed results as to the implementation of their stated goals at the time of this writing. The goals were to post the following on their website:

  • Information about all the inspections the agency conducts related to market products, rather than the current disclosure of piecemeal information
  • A significantly expanded set of enforcement letters
  • FDA evaluations of importers
  • Information about each case the Department of Justice files on FDA’s behalf at the time the case is filed and when the case is resolved.

We were able to find the information specified in the first three goals – import filer evaluation outcomesenforcement letters, an inspections database, a current list of press releases when DOJ cases are resolved, and a list of cargo thefts. However, we were unable to find any information regarding ongoing criminal investigations or recently filed cases.

The report details all the regulatory compliance data the FDA manages and breaks out which pieces are already publicly available. The list of publicly available data includes import refusal reports, recalls, annual enforcement statistics, and warning letters. The report also describes the agency’s transparency efforts to date, which include forming an internal Transparency Task Force, posting a number of datasets on Data.gov, and launching a redesigned webpage and phone app.

In October the FDA voluntarily took its transparency efforts a step further and sought public comment on a draft proposal for a number of new transparency initiatives. As of January 2012, the FDA plans to pursue all eight projects. While we support their efforts to explore ways to increase the accessibility of FDA information, we generally find that these proposals lack precise goals and action items. Moving forward we hope to see real data being released as a result of these proposals.

Back in October I looked at the reports issued by several other agencies in response to the regulatory compliance memo. The Department of Transportation had a thorough report, but my analysis found a lack of follow through when it came to actually posting new datasets on Data.gov. DOT and Data.gov were responsive to these concerns and added the datasets almost immediately. I also looked at the Environmental Protection Agency and Department of Commerce reports and found that the EPA is an avid user of Data.gov, while Commerce never even mentioned the platform in its report.

Let’s hope the FDA maintains momentum and turns these transparency proposals into concrete projects that will facilitate public access to the agency’s data.

Policy Fellow Matt Rumsey and Policy Intern Cassandra LaRussa contributed to the research for this post.