In a significant development pertaining to drug misbranding offenses, the U.S. Court of Appeals for the Ninth Circuit has empowered the Food and Drug Administration’s (FDA) criminal enforcement efforts. This follows the Court’s ruling on September 20, 2023, in United States v. Marschall, 2023 U.S. App. LEXIS 24886.
In the ruling, the Court held that certain felony offenses related to the introduction of misbranded drugs into commerce don’t require proof of scienter. This essentially means that an individual or a company involved in marketing, shipping, or selling such drugs could find themselves charged with a felony, irrespective of whether they had any criminal intent.
This is anticipated to have significant implications for companies and individuals engaged in the pharmaceutical sector. The verdict imposes a strict liability for drug misbranding offences, enhancing the existing FDA’s capability to enforce its criminal sanctions.
The broad reach of this ruling poses a significant consideration for anyone operating within the drug industry—especially given the fact that one can be prosecuted regardless of their knowledge or intent about the misbranded drugs.
This underlines the necessity for companies and legal professionals working in the sector, to reassess their compliance procedures related to drug branding and marketing.
For further details, refer to the original ruling of the United States v. Marschall case here.