In May 2019, the Office of the Legal Counsel (OLC) in the US Department of Justice (DOJ) published an opinion determining that drugs intended for use in lethal injections are not classified as a “drug” or “device” within the meaning of the Federal Food, Drug, and Cosmetic Act (FDCA), and are therefore not subject to regulation by FDA.
Following this, the Department of Justice announced in July that it will resume capital punishment after a 16 year hiatus using a single-drug execution protocol consisting of pentobarbital. The Government has set execution dates for five inmates, running from 9 December 2019 to 15 January 2020. Faced with unanimous opposition to the misuse of their medicines from every FDA-approved manufacturer, it is possible that the DOJ will seek to import foreign non-FDA approved pentobarbital for use in lethal injections.
Legal experts at Sidley Austin LLP have highlighted that the OLC opinion threatens the FDA’s claims-based interpretation of “intended use”, and could affect the liability of manufacturers in cases such as off-label promotion investigations, in which the FDCA’s misbranding and new drug/device approval provisions are at issue. Read more from their report.