FDA Initiative — Recall Information Now Readily Available

Searcy Denney Scarola Barnhart & Shipley
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The Food and Drug Administration is modernizing the way it reports recalls of products that pose risks to consumers. Through the development of an application programming interface, all recalls reported to the Recall Enterprise System now will be available to researchers.

protect-your-healthThe development of the software is significant because hundreds of drugs, foods and medical devices are recalled by the FDA – or their manufacturers – for such things as mislabeling or, worse, potential risks. The database will date back to 2004.

“The recalls in this dataset provide an illuminating window into both the safety of individual products and the safety of the marketplace at large,” wrote Dr. Taha Kass-Hout, of the FDA’s Office of Informatics and Technology Innovation, in the FDAVoice blog. “Recent reports have included such recalls as certain food products (for not containing the vitamins listed on the label), a soba noodle salad (for containing unlisted soy ingredients), and a pain reliever (for not following laboratory testing requirements).”

The new digital domain will enhance the FDA’s methods of informing the public about recalls via Flickr and RSS feeds. The more comprehensive site will enable researchers to access enforcement actions via their desktops, laptops and mobile apps and seamlessly add the information to consumer Web sites.

The modernization is part of the new openFDA, a soon-to-be-rolled-out (it’s in beta) Web site that has seen strong success in its reception. OpenFDA already has spawned www.researchae.com, which is a site for those seeking information about adverse events relating to products that have been recalled. It also is being used by journalists.

“More APIs will follow in the weeks ahead,” Kass-Hout wrote. “OpenFDA is taking an agile (development in small chunks of iterations) approach in the creation and release of these APIs, with the objective of getting feedback from developers and researchers (as well as from industry and the public)….”

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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