“Off-label” Cases Aren’t Going Away – DOJ Sheds Light on Direction of Enforcement of Misbranding Rules Governing Medical Products

On February 28, Ethan Davis, the U.S. Department of Justice’s (DOJ) deputy assistant attorney general responsible for consumer protection, gave a speech discussing the Department’s plans for enforcement of laws governing the marketing of medical products. Mr. Davis highlighted recent DOJ enforcement actions and previewed how the Department intends to approach the issue in the Trump administration. The speech was an important marker of how the current administration will navigate the tension between First Amendment protection for commercial speech and government enforcement in misbranding cases. The message: A renewed emphasis on what may be called “plus factors” and on the “rule of law” does not mean the DOJ will stop pursuing misbranding cases.

For those in the life sciences industry who expected the still-new administration to effect radical change in this always contentious area of enforcement, the speech offered little that was truly new. Now is by no means the time for industry to relax its compliance vigilance.

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