Broader Implications of Eliminating FDA Jurisdiction Over Execution Drugs

In 1977, Oklahoma began conducting executions by administering lethal injections of medicines, which is now the primary execution method in the United States. Early lethal injections used a three-drug combination that included sodium thiopental, but in recent years states also have used midazolam, pentobarbital, and even fentanyl. States increasingly have struggled to obtain legally manufactured versions of such substances, largely because of foreign governments’ and manufacturers’ actions. For example, in 2011, the European Union passed antitorture measures prohibiting trade in “goods that could be used for capital punishment.”¹ Hospira, the sole manufacturer of sodium thiopental—then a key component of lethal injection protocols—was manufacturing in Italy and discontinued production. Other pharmaceutical companies sought to prevent their products’ use in executions through restrictions in sales contracts. In response, states began purchasing products that lacked Food and Drug Administration (FDA) approval (e.g., by importing unapproved substances or purchasing unapproved compounded substances), and people sentenced to execution have brought legal challenges asserting violations of the Federal Food, Drug, and Cosmetic Act (FDCA).

In May 2019, however, the Department of Justice’s Office of Legal Counsel (OLC) issued an opinion asserting that substances intended for execution are not “drugs” under the FDCA and that the FDA lacks authority to regulate them.² Although one federal appellate court recently concluded, to the contrary, that execution substances are “drugs” under the FDCA³ and a 2012 court order in another case requires the FDA to prevent the importation of sodium thiopental,⁴ this OLC opinion stymies the FDA’s ability to regulate execution substances. This is because the FDA generally must follow OLC opinions, FDA decisions not to enforce FDCA requirements (including for execution substances) often are not reviewable by courts,⁵ and the 2012 court order applies only to sodium thiopental in the context of importation—and not other substances.⁴ Indeed, the FDA indicated it would comply with the OLC opinion. Lethal injections with unregulated substances, therefore, may be likely if the opinion stands. And since the federal government resumed executions in 2020—after having halted them in 2003—some court challenges have argued that the federal government has used compounded pentobarbital in violation of the FDCA.³

We argue that it was a grave mistake for the OLC to take the position that the FDA lacks jurisdiction over execution substances, and it is a decision that the Department of Justice can now undo. There are strong legal bases for concluding that these substances are drugs in the FDA’s purview and compelling public health reasons for doing so. Allowing states and the federal government to source lethal injection substances from outside the regulated supply chain not only exposes individuals being executed to uncertain and unnecessary risks⁶ but also may enable a broader unregulated market for these drugs.⁷

LEGAL BASIS

The FDCA broadly defines “drugs” subject to FDA regulation as including “articles” that are intended to “affect the structure or any function of the body.”⁸ Execution substances seem to fall within this part of the definition’s plain language. Indeed, the 2019 OLC opinion acknowledges that human execution substances “literally” affect the structure or function of the body,² and one federal appellate court has concluded that the FDCA’s requirements for drug importation apply to substances intended for execution.³ And, for more than 40 years, the FDA has regulated animal euthanasia substances as drugs “clearly intended to affect the function of the body by inducing death.”⁹

Nevertheless, the Supreme Court has never decided what it called “the thorny question” of the FDA’s jurisdiction over execution substances,⁵ and the OLC opinion offered various reasons such substances are not drugs within FDA jurisdiction. Ultimately, however, the OLC’s reasoning was flawed.

For example, the OLC argued that substances intended for lethal injection “could hardly be found ‘safe and effective,’” and thus the FDA would be required to ban them, effectively banning lethal injection—a result that Congress could not have intended.² Although the OLC took the position that animal euthanasia substances are not analogous to those intended for executions, the FDA has concluded that animal drugs intended to induce death are safe and effective for that purpose when they “result in a humane and painless death.”⁹ Because the legal standards for approving new animal and human drugs mirror each other, the FDA similarly could approve a drug as safe and effective for inducing death in humans. Such an approval likely could be based on nontrial data, such as animal studies, as in other contexts where conducting clinical trials can be unethical.

The OLC further argues that, if the drug definition covers execution substances, all means of execution, including guns and electric chairs, would be within FDA jurisdiction. Although it is true that the FDCA’s device definition, like its drug definition, encompasses products intended to affect the body’s structure or function, the FDA has long drawn commonsense boundaries around what is a device versus a consumer product outside its purview. For example, the FDA has declined to regulate exercise equipment as devices absent an intended therapeutic use (e.g., physical therapy), even though such equipment technically seems intended to affect structure or function. The FDA similarly could interpret the device definition as excluding traditional, nonchemical means of execution outside the agency’s expertise, such as guns and electric chairs. Moreover, for guns specifically, numerous federal laws regulate production and sales, none of which rely on the FDA, which may suggest that Congress, having created other means of oversight, intends guns to be outside the FDA’s purview. In short, as the Supreme Court stated, the scope of the FDCA should not be “narrowed . . . by envisioning extreme possible applications.”¹⁰

PUBLIC HEALTH BASIS

Interpreting the FDA’s jurisdiction as reaching execution substances is critical both for avoiding unnecessary and significant harms to individuals being executed and for protecting public health overall. This can be so even when FDA approval may not be required, for example for off-label execution uses of drugs approved for other purposes, such as fentanyl. In fact, the problem for states and the federal government often has not been that the FDA has not approved drugs for executions. Rather, it has been that drug manufacturers have sought to prevent their products’ use in executions, including, in at least one instance, suing a state government that purchased a drug for executions seemingly in contravention of the manufacturer’s sales contracts.¹¹ But even when the FDA has not approved a particular use, FDA oversight is important for ensuring drug quality.

When states or the federal government purchase unregulated drugs for executions, they, and any physicians involved,¹² have little assurance about the products’ quality. Although courts can prohibit execution methods as constitutionally impermissible cruel and unusual punishment, the bar is high for doing so. The Supreme Court has held that execution substances may be used unless there is a “substantial risk of severe pain” and people sentenced to executions identify an available alternative without that risk—a standard that, as explained by Justice Sonia Sotomayor in a dissent, could permit execution methods that are “intolerably painful—even to the point of being the chemical equivalent of burning alive.”¹³ Additionally, judges simply have limited expertise to identify and address drug quality problems.

Drugs that do not contain the purported active ingredients at the purported dosages, or were not produced consistent with good manufacturing practices, are associated with serious risks. For example, midazolam, when used in two- or three-drug execution protocols, is intended to render the incarcerated person unconscious but does not affect the sensation of pain. The dosage, therefore, is critical: if the substance is subpotent, individuals may experience severe pain from subsequently administered drugs.⁶ Executions with pentobarbital alone, in theory, would not pose a similar risk of pain. In practice, however, some pentobarbital used in executions appears to have expired or to have been manufactured or stored inappropriately (e.g., it appeared “cloudy”).¹⁴ Individuals executed with compounded pentobarbital have complained of burning sensations, and some appeared to be writhing in pain. Such issues are consistent with evidence from outside the execution context that compounded drugs—which can be exempt from certain FDA requirements—have been associated with serious quality problems that have even caused deaths, such as during a 2012 fungal meningitis outbreak traced to compounded drugs.¹⁵

Moreover, because of secrecy and lack of expert regulation, such incidents often leave more questions than answers about what went wrong. Even for unapproved, off-label execution uses, FDA oversight could lead to greater transparency, including an ability to track drugs involved in botched executions back to their source. This could help determine a problem’s cause after the fact, as well as prevent risks in future executions or patient care (e.g., through enabling notification of other states or pharmacies about substandard drugs).

Unregulated execution drugs also may pose other risks to the general public. Perhaps most importantly, by procuring drugs outside legitimate supply chains, governments may help to foster unregulated markets that are difficult to control once established. This concern is not theoretical; for instance, unapproved sodium thiopental imported in 2010 from a UK company operating out of a driving school ended up in a Georgia pharmacy.⁴ And Congress has recognized the public health importance of a tightly regulated drug supply chain.^16,17 This is not to say that FDA oversight is the only mechanism available to protect drug supply chains or that any regulatory scheme is likely to completely eradicate unregulated drug markets. But the FDA’s authority is one important tool that can be used to protect both people sentenced to execution and the public’s health overall.

NEXT STEPS

The United States began using drugs for execution in part to medicalize the death penalty to make it more publicly acceptable. But using medical means for executions has unintended consequences, including raising questions about whether the FDA should be involved in the oversight of lethal injection executions. Although expressly affirming the FDA’s jurisdiction over execution substances may run the risk of further medicalizing the death penalty, this risk must be weighed against the dangers associated with limited expert oversight of the substances that governments use to cause death. Whether or not the FDA regulates execution substances, lethal injection executions seem likely to continue. The OLC’s 2019 decision to block FDA oversight has troubling ramifications for individuals sentenced to death and the public more broadly. The opinion might also be understood not as an isolated legal document specific to the controversial area of capital punishment but as aligned with other recent efforts to undermine the FDA’s critical role in drug regulation. These include attempts to influence the agency’s emergency use authorization decisions for COVID-19 products—efforts that former FDA commissioners, among others, have identified as deeply concerning.¹⁸

At the same time, there is a relatively easy solution available for the specific problems directly raised by the 2019 OLC opinion: the OLC can undo that opinion. This step, as a legal matter, would enable the FDA to assert jurisdiction over substances intended for executions. Importantly, it also would signal the current presidential administration’s support for the agency enforcing the requirements of the FDCA in the context of execution substances, in turn protecting individuals sentenced to execution, drug supply chains, and the public health. Perhaps, too, it would serve as one counter to the trend of chipping away at the FDA’s role in protecting the public health.