In May 2019, the Office of 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 the Food & Drug Administration (FDA).
However, in September 2019, a federal court in Tennessee recognized that this opinion “directly conflicts” with a 2013 ruling by the US Court of Appeals for the District of Columbia, which held that the FDA’s failure to block the importation of a foreign lethal injection chemical violated the FDCA. The court also noted that the OLC opinion is only advisory and “do[es] not have the effect of law.”
In addition, 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.