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.

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