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Justice Department: If FDA Regulated Execution Drugs, They Would Ban Them

The Justice Department’s Office of Legal Counsel drafted an opinion that definitively argues the Food and Drug Administration (FDA) may not ban or regulate drugs used to execute prisoners.

As state governments that have yet to abolish the death penalty struggle to obtain drugs for lethal injections, a key issue is whether certain lethal injection protocols violate the Constitution’s prohibition against cruel and unusual punishment.

Texas sued the FDA in 2017 after the agency blocked [PDF] a shipment of lethal injection drugs. The state argued the drugs were lawful, complied with FDA standards, and the FDA was wrong to apply an import ban against sodium thiopental.

Texas argued the “statutory and regulatory requirements” that the FDA invoked “do not apply in this law enforcement context.”

The Justice Department’s legal opinion appears to endorse Texas’ arguments in favor of unregulated execution drugs.

“FDA has not historically exercised jurisdiction over articles intended to carry out a lawful sentence of capital punishment,” Assistant Attorney General Steven A. Engel wrote.

The OLC opinion [PDF], which was completed on May 3, insists the FDA has not typically claimed authority over the methods by which federal and state governments carry out executions.

“That is in no small part because one of the FDCA’s [Federal Food, Drug, and Cosmetic Act] fundamental purposes is to ensure that drugs and devices marketed in interstate commerce are safe and effective for their intended uses—a goal that markedly conflicts with the purpose of an execution,” Engel contended.

What follows is a kind of circular argument. If the FDA were to regulate execution drugs, they would have to ban them. Since capital punishment has not been ruled unconstitutional and Congress passed death penalty laws, the FDA cannot reasonably be permitted to make decisions related to the use of the drugs.

Engel suggested, “If the 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. Yet, the Constitution and the laws of the United States presuppose the continued availability of capital punishment for the most heinous federal and state crimes.”

The opinion worries the FDA would be able to ban the drugs and “seek fines or prosecutions against individuals involved in their sale or distribution.”

Because there is no “therapeutic benefit” to execution drugs, or electric chairs, gallows, or firearms used by firing squads, the FDA could not reasonably regulate them.

Engel makes it fairly clear through the opinion that the biggest threat to the death penalty may be the FDA. Were it to be involved in executions, it would make administering lethal injections even more impractical because the FDA would have to require correctional departments to meet certain standards.

But as Engel pointed out, that would be nearly impossible because execution drugs are exclusively meant for inflicting harm. There would be no humane way for the FDA to conduct scientific reviews. There would be no “patient experience data.”

Provisions of the FDCA cannot “sensibly be read to allow an article’s intended use to be the causing of death in an execution,” Engel concluded.

“It would present a serious intrusion on state sovereignty if Congress sought, under the guise of drug safety regulation, to bar states from effectuating otherwise lawful death sentences.”

The use of certain lethal injection protocols or specific execution drugs is in flux. Constitutional questions are far from settled, though there have been prior rulings. States also cannot find suppliers for specific types of drugs and have resorted to illegally importing supplies so they can keep executing death row prisoners.

In 2015, the Supreme Court ruled prisoners “failed to establish a likelihood of success on the merits of their claim that the use of midazolam violates the Eighth Amendment.”

Midazolam is a sedative, which anesthesiologists have warned against using because the drug lacks the properties necessary to make a person immune to pain.

The Intercept’s Liliana Segura reported on an evidentiary hearing in Ohio, where Magistrate Judge Michael Marz  became convinced midazolam was “very likely” to result in pulmonary edema, where a person felt like they were “waterboarded.”

In January, Marz halted the execution of Warren Henness because it would plainly violate the Eighth Amendment’s prohibition against cruel and unusual punishment.

A federal trial recently unfolded in Arkansas over two weeks on the issue of whether the state’s three-drug protocol is constitutional.

Meanwhile, states like Texas and Arkansas have moved to expand secrecy laws that block the public from knowing information about the suppliers’ of execution drugs. The Texas Supreme Court ruled against disclosure in April, arguing it “would create a substantial threat of physical harm to the source’s employees and others.”

Death penalty abolition has ramped up, and this macabre legal opinion represents a last-ditch effort by the Justice Department to salvage what is left of the death penalty in 30 states before they throw in the towel and join the rest of the country in moving away from executions.

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Kevin Gosztola

Kevin Gosztola

Kevin Gosztola is managing editor of Shadowproof. He also produces and co-hosts the weekly podcast, "Unauthorized Disclosure."