Regulatory Focus™ > News Articles > FDA Plans Major Overhaul of Recall Reporting

FDA Plans Major Overhaul of Recall Reporting

Posted 08 June 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration's (FDA) weekly enforcement reports, which detail product recalls and corrections taken during the week, are about to get a major overhaul according to an agency announcement.

The agency last week reported in a little-noticed item within its enforcement report that it would be making changes to the way it updates its enforcement reports for pharmaceutical product recalls. The agency wrote at the time it intends to "modify the drug product section of the enforcement report… to include actions that have been determined to be recalls, but that remain in the process of being classified as a Class I, II or III actions." Class I recalls are rated to be the most serious of recalls, while Class II and Class III recalls respectively indicate potentially serious and minor problems.

The agency said it would launch a pilot project to make the changes, and would be seeking comments and suggestions on how to improve the process.

Days after making the announcement, a study published in the journal Archives of Internal Medicinesfaulted the agency's recall notification methods, calling them ineffective, convoluted and containing too much information.

"I think a good system would indicate all of the Class I recalls, and it wouldn't necessarily communicate recalls the FDA deems less important, such as Class II and Class III," Joshua Gagne, the lead author of the study, said. "It's very possible that these important recalls are being lost in the less important ones."

FDA seems to have taken Gagne's-and others'-criticism to heart, and said it would roll out a new enforcement report in mid-June aimed at delivering a "simpler, clearer report that encourages data download and analyses while also providing savings and encouraging future innovation for Government."

"Instead of the narrative report you see now, you will find a data-driven report encouraging innovative stakeholders to extract more intelligence out of the data and providing FDA a baseline as it moves forward in its efforts to integrate the Agency's compliance and enforcement data," explained FDA.

The strategy may also be a part of the Obama administration's attempt to open up agency information. In a 23 May 2012 memo entitled, "Digital Government: Building a 21st Century Platform to Better Serve the American People," the administration called for promoting "open data" and content through the use of open Application Programming Interfaces (APIs).

Regulatory Focus reported at the time ("White House Wants Agencies to Develop Mobile Technologies, Open APIs") that the development could lead to enforcement reports being published in more user-friendly and analytics-friendly formats.

The agency also plans to solicit feedback on its new enforcement report layout, which it will accept at

Read more:

Enforcement Report for June 6, 2012

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