The U.S. Department of Justice (DOJ) has issued an advisory memorandum declaring that the Food and Drug Administration (FDA) “lacks jurisdiction” to regulate execution drugs, including enforcing federal laws that prohibit the import of such drugs from abroad. The memorandum, authored by Assistant Attorney General Steven A. Engel (pictured) for the Department’s Office of Legal Counsel, places the administration squarely in conflict with a 2012 federal district court order requiring the FDA to enforce federal laws barring the importation of unapproved or misbranded drugs or drugs that come from unregistered facilities. The ruling, which came in a case brought by death-row prisoners to force the agency to comply with federal law, was upheld by a federal appeals court in 2013, and the FDA is still permanently enjoined by the ruling from allowing the illegal importation of execution drugs.
The DOJ legal opinion — which is binding on federal agencies — is apparently a response to the FDA’s seizure and impoundment of lethal-injection drugs that prison officials in Texas and Arizona had attempted to import in 2015 for use in executions. After the drug seizure, the Texas Department of Criminal Justice sued the FDA, and in April 2017, the agency issued a final order refusing to release the drugs. The FDA’s order stated: “The [2012] court order requires the FDA to refuse admission to the US any shipment of foreign manufactured sodium thiopental being offered for importation that appears to be an unapproved new drug or a misbranded drug.” Several states have attempted to illegally import sodium thiopental, an anesthetic once commonly used in executions, after its U.S. manufacturer ceased production in 2009.
Engel’s memorandum bases the DOJ’s opinion on a U.S. Supreme Court case addressing whether the FDA can regulate tobacco products. In FDA v. Brown & Williamson Tobacco Corp. (2000), the Court found that the FDA could not regulate tobacco products because “they cannot be used safely for any therapeutic purpose,” but “they cannot be banned” because Congress had clearly intended for tobacco to be available. Engel wrote that the situations were analogous: “Congress has repeatedly authorized the death penalty on the assumption that there are lawful means to carry it out, but the regulation of such articles under the [Federal Food, Drug, and Cosmetic Act of 1938] would effectively require their prohibition because they could hardly be found ‘safe and effective’ for such an intended use.”
Fordham University Law Professor Deborah Denno said the opinion “is intended to allow departments of corrections to access drugs outside the country because they’re having so much difficulty doing so,” but, according to The Washington Post, “The Justice Department’s opinion is unlikely to have any immediate effect … because the FDA is still operating under the 2012 injunction.” The Justice Department has not taken any steps to have the injunction lifted. As long as the injunction remains in place, the opinion represents only the views of the Department of Justice, and does not have the force of law.
(Laurie McGinley and Mark Berman, Justice Department says FDA ‘lacks jurisdiction’ over death-penalty drugs, The Washington Post, May 14, 2019; Charlie Savage, Justice Dept. Stops F.D.A. From Regulating Death-Penalty Drugs, The New York Times, May 14, 2019; Chris Geidner (@chrisgeidner), “BREAKING: DOJ’s Office of Legal Counsel concludes that the FDA lacks jurisdiction to regulate drugs used in executions…” and following tweets, Twitter, May 14, 2019.) Read the memorandum. See Lethal Injection.
