FDA Task Force Recommends Publishing More Inspections Data

An FDA task force Apr. 22 recommended the agency expand the amount of information about inspections and enforcement that it releases, allowing the public to view a more detailed record of a company’s compliance history.

In an ambitious effort to give more access to data about inspections of drugmakers, the task force recommended the agency speed up the collection and reporting of data from investigators in the field, provide greater trending information about what inspectors are citing companies for, broken down geographically, and make data more readily accessible for third parties to disseminate.

In addition to providing more information, the agency task force also recommended making it easier for drugmakers to report mistakes that they find in agency records and request corrections directly through the FDA website.

The plans are outlined in the report of the agency’s transparency initiative that analyzed ways the Office of Regulatory Affairs’ Inspection Observation Database could be made more useful. It has been presented to FDA Commissioner Margaret Hamburg for consideration.

One key recommendation is to allow users to search for specific violations at a company that were found during inspection, rather than simply identifying the status of the inspection as no action indicated, voluntary action indicated or official action indicated.

The work groups that made up the transparency initiative also examined ways the FDA can make better use of social media in communicating the agency’s compliance and enforcement efforts.

Currently, the FDA uses social media platforms Facebook, YouTube, Flicker and Twitter, where it has 550,000 followers.

The transparency initiative report notes that the agency has the tools it needs to become more active on social media to highlight enforcement activities, but it has not been an agency priority.

Coming up in October: the Ninth Annual FDA Inspections Summit. If your data is going to be published, you ought to make sure it’s good. Sign up now.