Important Policy Statement: US Department of Justice and FDA-Regulated Industry

On December 7, 2017, Deputy Assistant Attorney General Ethan P. Davis, Consumer Protection Branch, gave a speech at the Food and Drug Law Institute Enforcement, Litigation and Compliance Conference in Washington, DC outlining the US Department of Justice’s current enforcement approach for FDA-regulated companies.

The speech is the first significant policy statement by the Attorney General’s office directed at FDA-regulated industry, and gives great insight into how DOJ will apply its enforcement discretion – or not – to bad actor companies and individuals.

This speech should be read and understood by all senior industry personnel with roles in compliance, regulatory, quality and legal.

We are happy to provide a full transcript of this speech with our compliments as a service to FDA-regulated industry.