In an Unusual Administrative Law Development, DOJ’s OLC States That FDA Has No Regulatory Authority Over Articles Used in Lawful Executions

In a document as interesting for the “why” as the “what,” the Department of Justice, Office of Legal Counsel (“OLC”) recently issued a memorandum legal opinion concerning “Whether the Food and Drug Administration Has Jurisdiction over Articles Intended for Use in Lawful Executions.”

The issuance of an OLC opinion related to the FDC Act, while notable is not, in itself, surprising.  As the DOJ website explains:  OLC “drafts legal opinions of the Attorney General and provides its own written opinions and other advice in response to requests from the Counsel to the President, the various agencies of the Executive Branch, and other components of the Department of Justice.  Such requests typically deal with legal issues of particular complexity and importance or those about which two or more agencies are in disagreement.”

In the past OLC has, for example, offered opinions solicited by FDA’s Chief Counsel, the HHS Acting General Counsel, and joint EPA and FDA requests.  In the present opinion, there is no indication that FDA requested an opinion.  In a footnote, the opinion notes that OLC “solicited and considered the views of FDA and of the Office of the Associate Attorney General.”  What the opinion does not say is why OLC is opining on FDA’s jurisdiction.  The Agency regularly makes jurisdictional determinations and DOJ represents FDA in court when those determinations are challenged.  The opinion notes a current injunction and an FDA position articulated in 2017, but if FDA had re-evaluated the FDC Act, as the opinion notes, the Agency could have simply explained why it did so.  Under Supreme Court precedent, FDA’s interpretation of ambiguous jurisdictional statutory authority is entitled to deference.   Instead, OLC issued an opinion.

OLC concluded that articles intended for use in executions carried out by a state or the federal government cannot be regulated as “drugs” or “devices” under the Federal Food, Drug, and Cosmetic Act (“FDCA”) and that FDA therefore lacks jurisdiction to regulate articles intended for that use.  The OLC opinion may allow states to begin importing a drug used in lethal injection protocols that is no longer available in the US, contrary to a permanent injunction that has banned its import.

In concluding that FDA cannot regulate articles intended for use in lawful executions, the OLC cites to FDA v. Brown & Williamson Tobacco Corp.  In Brown & Williamson (here), the Supreme Court held that Congress had not given the FDA the authority to regulate tobacco products, because if tobacco products were subject to FDA regulation, the FDCA would require their prohibition because they are not safe or effective or any intended use.  FDA v. Brown & Williamson Tobacco Corp, 529 U.S. 120, 137–39 (2000).  The OLC is extending the same reasoning to the FDA regulation of articles intended for use in lawful executions.  OLC’s opinion is not limited to drugs used in lethal injection, a common method of capital punishment, but is broad and covers articles intended for use in lawful executions generally (e.g., electric chairs, gas chambers, gallows, firearms used by firing squads).

The OLC opinion begins with a summary of the regulatory structure of the FDCA and the history of its intersection with capital punishment.  OLC explains that an article may be a “drug” or “device” for some uses but not for others, depending on whether the product is intended to be used to treat disease or other conditions, or to otherwise affect the structure or function of the body.  For example, FDA regulates “medical gases,” but not industrial gases that are chemically identical because the latter do not have a medical purpose.  OLC also explains that FDA does not regulate the “off-label” prescribing of a drug or device for a use not approved by FDA, as off-label prescribing is considered the practice of medicine, which is beyond FDA’s regulatory purview.  According to OLC, state use of FDA-approved drugs in lethal injection essentially amounts to off-label use.

In recent years, many states have had difficulty accessing drugs used in lethal injection protocols from US suppliers.  Many pharmaceutical companies that manufacture drugs used in lethal injection protocols, as well as wholesalers that distribute said products, have publicly objected to their drugs being used in capital punishment and will not sell them to states for that purpose.  In 2009, the only US manufacturer of sodium thiopental, a barbiturate commonly used in multi-drug lethal injection protocols, ceased production of the drug entirely.  When states were no longer able to access sodium thiopental domestically, they then began to import it from international suppliers.  A group of death row inmates challenged the state import of sodium thiopental for lethal injection and the court issued a permanent injunction requiring FDA to block the importation of sodium thiopental on the grounds that it was unapproved and misbranded.  Beaty v. FDA, 853 F. Supp. 2d 30 (D.D.C. 2012) (here; see our previous post here).

After setting forth a history of the FDCA and capital punishment, OLC turns to the aforementioned Brown & Williamson, which established that FDA lacks jurisdiction to regulate articles intended for a use not traditionally regulated by FDA, when those articles cannot be safe and effective for such intended use, and Congress has otherwise made clear its expectation that at least some of those articles shall remain lawful and available for that use.  OLC then extends the same analysis to articles used in capital punishment and comes to three main conclusions:

1. If FDCA applied to electric chairs, gallows, gas chambers, firearms used in firing squads, and substances used in lethal-injection protocols, the statute would effectively ban those articles
2. The Constitution and laws of the United States allow for the continued availability of capital punishment
3. FDA did not expressly assert the authority to regulate articles intended for use in executions at any time before 2017 and that such an assertion cannot be reconciled with the FDCA and other federal law.

In several spots, the OLC opinion notes the limits of its analysis.  For example, it notably declines to discuss whether this analysis of FDA jurisdiction extends to drugs used in physician assisted suicide, stating that “In marked contrast with capital punishment and tobacco products, at the time of the FDCA’s enactment, there was not—so far as we are aware—any history of federal or state laws authorizing human euthanasia.”  OLC Opinion at 25.

Despite these disclaimers, substantively, the OLC opinion provides potential fodder for future jurisdictional fights with FDA. Procedurally, it is a reminder of an additional agency with the executive branch that can opine on FDC Act questions.  As for the “why”, the opinion never explains who requested it.  The Attorney General, White House Counsel?  Was it the result of a dispute between FDA and another agency?  The opinion raises other questions.  Will DOJ and FDA use the opinion in the Beaty litigation?  If so, will the court give it Chevron deference?  We’ll be watching and posting about further developments.