Off-Label Promotion And The First Amendment Updates


Although activity around the Amarin and Pacira cases has settled down, questions regarding the FDA’s position on truthful off-label promotion-and whether it comports with First Amendment free speech principles—persist.

The FDA has announced a two-day public hearing on November 9 and 10, 2016 regarding “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.”  In-person attendance is via pre-registration, written comments are accepted via (and should reflect the docket number “FDA-2016-N-1149”), and the meeting will be webcast as well.

Even more recently, on September 19, 2016, the Medical Information Working Group (MIWG) filed an amicus brief on these issues with the District of Massachusetts in United States v. Facteau in support of the defendants’ motion for a judgment of acquittal or new trial.

As the MIWG brief explains:

In particular, the MIWG has sought to address concerns that the current enforcement scheme is at odds with fundamental First and Fifth Amendment principles that permit manufacturers to engage in truthful and non-misleading communications about off-label uses of their products.  The unclear rules that characterize the regulatory framework, and the Government’s expansive and ad-hoc approach to enforcement, provide inadequate notice of the line between permissible and impermissible speech and, as a result, manufacturers’ constitutionally protected speech is chilled.

Id. at 1.

This MIWG brief should be a useful resource for anyone addressing off-label promotion issues, regardless of whether those involve alleged regulatory violations (as with the criminal prosecution in Facteau) or allegations of tort liability in civil litigation.  And, it cites to our colleagues over at the Drug and Device Law Blog for their post about how long it has taken to get clarity from the FDA about the First Amendment free speech issues with its regulation of off-label promotion.

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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