Justice Dept. Stops F.D.A. From Regulating Death-Penalty Drugs

WASHINGTON — The Justice Department has declared that the Food and Drug Administration lacks legal authority to regulate drugs that are used to carry out lethal injections, opening the door for states to import scarce death-penalty drugs even if the agency has not approved their use.

In a 26-page memo signed on May 3 and quietly posted Tuesday evening on the Justice Department’s website, Steven A. Engel, the head of the department’s powerful Office of Legal Counsel, concluded that the F.D.A. had no right to regulate death-penalty drugs because they do not count as a “drug” or a “device” within the meaning of the Federal Food, Drug and Cosmetic Act of 1938.

Under the act, drugs that alter or affect the body cannot be brought to market in the United States unless and until the F.D.A. has approved them as safe. But in a 2000 ruling, the Supreme Court held that the F.D.A. lacked authority to regulate tobacco because it could not be used safely and yet there was no sign that Congress had intended for it to be banned.

Relying heavily on the exception the Supreme Court carved out in that ruling, Mr. Engel said that death-penalty drugs similarly do not come under the agency’s control.

The law that gives the agency the power to make sure drugs and devices are safe “cannot sensibly be applied” to death-penalty drugs because doing so would mean the act would effectively ban them, Mr. Engel wrote. “Yet the Constitution and laws of the United States presuppose the continued availability of capital punishment for the most heinous federal and state crimes.”

Interpretations of the Constitution and federal law by the Office of Legal Counsel are binding across the executive branch, so Mr. Engel’s ruling means the F.D.A. must cease interfering with states’ attempts to import drugs like sodium thiopental, an anesthetic used as part of a lethal-injection cocktail in combination with other drugs that paralyze prisoners’ muscles and stop their hearts from beating.

States that have the death penalty have faced delays in carrying out executions using lethal injections because of a shortage of the drugs used for that purpose, including thiopental. The last American manufacturer of thiopental stopped making it in 2009, Mr. Engel wrote.

Against that backdrop, a group of death row inmates sued the F.D.A. in 2011 in an attempt to force it to block imports of thiopental as a misbranded and unapproved drug. The next year, a Federal District Court judge ruled that the agency had a legal duty to block its importation and no discretion to choose not to do so. And an appeals court later unanimously agreed.

Under the Obama administration, the F.D.A. accepted that ruling. In 2015, for example, the agency announced that it had impounded shipments of thiopental that Arizona and Texas had sought to import, saying that it was an unapproved drug that could not be imported into the United States under the 2012 court opinions.

But Mr. Engel wrote that the 2012 rulings turned only on the question of whether the F.D.A. had discretionary power to choose not to use its drug enforcement powers over an imported substance. The courts did not address “the broader question of F.D.A.’s jurisdiction,” he wrote — leaving the Justice Department free to decide the agency lacked any over execution drugs.

And he stressed that even if the question of whether the Food, Drug and Cosmetic Act should apply to an inherently unsafe substance like execution drugs were ambiguous, it should be interpreted in a manner that respects the right of states to decide for themselves whether to have the death penalty.

The principle of federalism, he said, “provides further support for the conclusion that the F.D.C.A. should not be read to regulate — and therefore, effectively prohibit — the states’ administration of capital punishment.”

Mr. Engel’s memo was addressed to the attorney general. It did not say whether the analysis had been commissioned by the former attorney general Jeff Sessions; the former acting attorney general Matthew Whitaker; or the current attorney general, William P. Barr.

But the issue arose early in the Trump administration because in January 2017, when Mr. Trump took office, the state of Texas sued the F.D.A., asking a judge to order it to release the shipment of vials of thiopental that the state had tried to import in July 2015.


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