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.
The OLC Uses FDA v. Brown & Williamson Tobacco Corp. as the Basis to Limit FDA’s Jurisdiction to Regulate Drugs Intended for Execution
The OLC also addresses the limits of FDA’s jurisdiction in this opinion. When addressing FDA’s jurisdictional limits, the OLC relied heavily on FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000), a Supreme Court case that held FDA had a limited authority to regulate tobacco products. In that case, the Court determined that if tobacco products were regulated as drugs or devices under the Food, Drugs, and Cosmetics Act (“FDCA”), their sale would be prohibited because they could not be “safe” or “effective” for their intended use. See 21 U.S.C. § 355; see also 21 C.F.R. § 314.50(d)(5). The OLC characterized this decision as the Court concluding that a ban on all tobacco products could not be the outcome that Congress intended.
Using the same logic, the OLC concluded the FDCA could not apply to articles intended for use in capital punishment. If it did, the FDCA would essentially ban their use because they would not be “safe” and “effective” for their intended use. As such, the OLC determined the FDCA cannot apply to articles used for execution because the Constitution and federal law contemplates the availability and lawfulness of capital punishment.
The OLC Opinion May Raise Other FDA Jurisdictional Challenges
The opinion raises a number of questions regarding FDA’s jurisdiction. For example, it is an open question as to how the OLC opinion, a decision binding to the executive branch, will be reconciled with the sodium thiopental injunction in effect from Beaty. The opinion makes clear its conclusion is narrow, such that it does not apply to the use of the drug for anesthetic purpose or FDA’s jurisdiction over physician-assisted suicide. Additionally, the arguments set forth in this opinion may open the door for other more creative challenges to FDA’s authority to regulate drugs and devices outside of the execution context.
Should you have any questions regarding the slip opinion or any of the issues raised in this alert, please do not hesitate to reach out to Rachael Pontikes, John Kendzior, or Shaylynn Veeder for further discussion.
This article is presented for informational purposes only and is not intended to constitute legal advice.
