> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Court Questions Criminalizing Off-Label Promotion
- URL: https://www.fdaweb.com/court-questions-criminalizing-off-label-promotion/
- Published: 2020-10-01T12:00:00.000Z
- Updated: 2026-09-14T16:31:03.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5147785

The Massachusetts federal court allowed misdemeanor convictions to stand in an off-label promotion case but said “it seems clear that the statutory and regulatory scheme needs to be re-thought.” Attorney **Stephen McConnell** (Reed Smith) writes online in a *Drug and Device Law Blog* [post](https://www.druganddevicelawblog.com/2020/10/d-mass-rejects-post-trial-motions-by-corporate-officers-accused-of-off-label-promotion.html?ref=fdaweb.com) that the judge pointed out there is no statute that specifically prohibits off-label marketing and yet the government continues to prosecute the conduct by patching together the misbranding and adulteration regulations.

“In short, this long opinion (*United States v. Facteau)* produces sad results for the defendants,” McConnell concludes. “The only consolation — and it is cold consolation for the defendants — is that this case is far from a ringing endorsement of the government’s aggressive prosecution.”