On June 2, 2014, the Food and Drug Administration launched openFDA, a program designed to improve access to publicly available data beginning with adverse event reports. While greater accessibility to adverse event reports has industry benefits, it may also put drug manufacturers at greater litigation risk. This potential exposure highlights the need to prepare adverse event reports with an eye toward avoiding admissions on causality or making other statements in the absence of complete information.
What It Includes: The June 2 launch of the openFDA website contains a searchable database of more than three million adverse drug event reports submitted by drug companies, consumers, and healthcare professionals from 2004 to 2013. These reports were previously available only through difficult-to-use reports or Freedom of Information Act requests.
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Topics: Adverse Events, Databases, FDA, FOIA, HHS, openFDA, Pharmaceutical, Prescription Drugs, Reporting Requirements, Transparency
Published In: Administrative Agency Updates, General Business Updates, Consumer Protection Updates, Health Updates, Products Liability Updates
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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