FDA can't regulate death penalty drugs, Justice Department says

The Food and Drug Administration does not have jurisdiction over death penalty drugs, the Justice Department said in an opinion."We conclude that arti...

Posted: May 15, 2019 9:00 AM

The Food and Drug Administration does not have jurisdiction over death penalty drugs, the Justice Department said in an opinion.

"We conclude that articles intended for use in capital punishment by a state or the federal government cannot be regulated as 'drugs' or 'devices' under the (Federal Food, Drug and Cosmetic Act)," Steven A. Engel, the head of the department's Office of Legal Counsel, wrote in a 26-page legal opinion signed May 3. "FDA accordingly lacks jurisdiction to regulate such articles for that intended use."

The decision comes as lethal injection drugs are in short supply. And it follows the FDA's 2015 seizure of 1,000 vials of sodium thiopental -- a drug used in lethal injection procedures -- from the Texas Department of Criminal Justice.

The state sued the FDA in January 2017, requesting that the agency release the drug from federal custody.

Sodium thiopental has been used in lethal injections since the 1970s, the DOJ said. It is typically used as part of a three-drug cocktail that first puts a prisoner to sleep, then brings on paralysis and finally, stops the heart.

In 2009, the only American manufacturer of the drug stopped producing it. And in 2012, the U.S. District Court for the District of Columbia issued an injunction that required the FDA to block the importation of the drug "on the grounds that it was unapproved and misbranded."

In contrast to the injunction, Tuesday's opinion said "FDA lacks jurisdiction to regulate articles intended for a use not traditionally regulated by FDA, when those articles cannot be safe and effective for such intended use."

The FDA, the Justice Department said, can't regulate an article that's intended for capital punishment in the US.

"FDA did not expressly assert the authority to regulate articles intended for use in executions at any time before 2017, and we believe that such an assertion cannot be reconciled with the [Federal Food, Drug, and Cosmetic Act] and other federal law," the opinion says.

Indiana Coronavirus Cases

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Reported Deaths: 12531
CountyCasesDeaths
Marion904161633
Lake48298874
Allen35720633
Hamilton31970396
St. Joseph29796510
Elkhart25331412
Vanderburgh21192377
Tippecanoe19927199
Johnson16312356
Porter15917269
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Wayne6622191
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Boone606888
Morgan6066124
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CountyCasesDeaths
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Lucas35069761
Stark29218837
Warren22294272
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Clermont18271210
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Fairfield14449157
Trumbull14239460
Greene13520212
Medina13290219
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Wood11460193
Portage10928155
Allen10742233
Richland10226205
Miami9984187
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Columbiana8086182
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Pickaway800199
Marion7963137
Wayne7837218
Erie6826184
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Geauga6030129
Hancock5965112
Ashtabula5917144
Scioto5906104
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Darke5021123
Belmont488388
Huron4761117
Jefferson4756107
Sandusky474494
Seneca4640103
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Washington458787
Mercer4577101
Auglaize454698
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Knox400486
Putnam3976101
Madison390947
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Ashland377195
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Brown368342
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Logan352459
Preble351771
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Williams301077
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Gallia220746
Adams215132
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Carroll179828
Paulding159223
Meigs134636
Noble128442
Monroe115636
Morgan100434
Harrison100132
Vinton76615
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