Life Science Compliance Update

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April 19, 2016

A Basic Geometry Lesson - FDA’s Off-label Losses

Lon - FDA's Off-label

The new decision in United States v. Vascular Solutions, Inc., provides the third point in a curve of the FDA's regulation of off-label promotion. This article provides a detailed explanation of the case, including the relevant jury instruction, an overview of the 2014 FDA Guidance document on scientific and medical publications, and possibilities for next steps for compliance officers

It is a fundamental tenet of geometry that three points are needed to determine a curve. Concerning the Food and Drug Administration ("FDA") and its regulation of off-label promotion versus the First Amendment, with United States v. Vascular Solutions, we now have our third point in the curve.

In Vascular Solutions, the government charged both Vascular Solutions and its president, Howard Root, with selling medical devices without FDA approval and with conspiring to defraud the United States by concealing the allegedly illegal activity.40 The government alleged that Vascular Solutions and Root engaged in a campaign to promote the Vari-Lase devices for ablation of perforator veins when the devices were only approved for use in superficial veins.

 

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