Reed Smith Client Alerts

In May 2019, the Department of Justice, Office of Legal Counsel (“OLC”) issued a slip opinion addressing the Food and Drug Administration’s (“FDA”) jurisdiction over articles intended for use in lawful executions. The opinion was issued pursuant to a request by the U.S. Attorney General’s Office for the OLC to address this matter because of years of conflict regarding the use of sodium thiopental in executions.  Importantly, the OLC concludes that FDA does not have jurisdiction over such articles.  It states “that articles intended for use in capital punishment by a state or the federal government cannot be regulated as 'drugs' or 'devices' under the FDCA [Federal Food, Drug and Cosmetic Act]" as the FDCA’s regulatory framework for drugs devices cannot sensibly be applied to articles intended in lawful executions.  The opinion emphasizes that if the FDCA applied to these types of articles, the statute would effectively ban them since these articles literally affect the structure and function of the body by causing all bodily functions to cease – thus these articles could never be found safe and effective for their intended use.

Background of the Underlying Conflict Regarding Sodium Thiopental in Executions

The opinion is the result of years of conflict regarding sodium thiopental. As the opinion explains, sodium thiopental was used by many States and the federal government in lethal injections from as far back as the 1970’s.  Prior to using the substance in lethal injections, sodium thiopental was widely used as a surgical anesthetic. Historically, FDA declined to use its enforcement discretion to regulate the use of sodium thiopental in executions.  Heckler v. Chaney, 470 U.S. 821 (1985).  However, in 2012 the sole American Manufacturer of sodium thiopental ceased production and States could only obtain the substance by importing it from foreign suppliers.  In 2011, a group of inmates from Arizona, California, and Tennessee brought suit against FDA for allowing the import of “misbranded” and an “unapproved new drug,” thiopental, to be imported in the U.S.  In 2012 the U.S. District Court for the District of Columbia issued a permanent injunction requiring FDA to block the importation of sodium thiopental on these grounds.  See Beaty v. FDA, 853 F. Supp. 2d 30 (D.D.C. 2012), aff ’d, Cook, 733 F.3d 1.  The Texas Department of Criminal Justice (“TDCJ”) has fought vehemently against this injunction and for the release of sodium thiopental that has been seized by FDA.  In 2017, FDA issued a letter confirming its authority over the imported substance (which the state of Texas did not deny) and determined the use of the drug for lethal injection was an unapproved new drug and misbranded.