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FDA Using Big Data Methods to Discover Drug Risks, Provide Access to Recall Information

Laurie A. Clarke
Colleen Heisey
Mark Mansour
Christopher M. Mikson
Emily K. Strunk
Jones Day - Washington Office

August 5, 2014

Previously published on July 2014

Through recently deployed initiatives, FDA is taking advantage of new data systems to gather and assess drug risk data and promote easier public access to adverse event and recall information. The two projects, Mini-Sentinel and open FDA, offer greater efficiencies than existing methods, such as the voluntary reporting process and Freedom of Information Act requests.

The open FDA initiative focuses on enhancing the Agency's public disclosure of information on adverse events, medication errors, and product recalls. In a recent blog post, FDA Chief Health Informatics Officer Taha Kass-Hout discusses the roll out of an application programming interface that provides software developers and researchers access to millions of drug and device recall reports. Several companies are already integrating this data into their products and services, and at least one new website allows users to query adverse event information. The San Francisco Gate outlines other potential benefits of the interface for start-up companies, such as using its information to improve existing technologies and learning to avoid mistakes others have encountered during the FDA review process.

Mini-Sentinel, a $116 million pilot program partnering FDA with private companies, actively pursues adverse event data by mining medical record databases for signs that drugs may be linked to problems. Before this initiative, FDA had to rely on voluntary reports from manufacturers, health care providers, patients, and caregivers—a method that yields copious amounts of information but has limited value because of its random reporting. Mini-Sentinel's standardized approach for gathering data directly from the 18 health plans and insurance companies participating in the program enables FDA scientists to hone in on the root causes of an adverse symptom, and the Agency has already required new warning labels as a result of these analyses. Although the pilot contract ends in September 2014, FDA officials and many industry leaders would like to see some form of Mini-Sentinel adopted as a permanent program.


The views expressed in this document are solely the views of the author and not Martindale-Hubbell. This document is intended for informational purposes only and is not legal advice or a substitute for consultation with a licensed legal professional in a particular case or circumstance.

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