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

Data is updated nightly.

Confirmed Cases: 76522

Reported Deaths: 3086
CountyConfirmedDeaths
Marion16194731
Lake7742281
Elkhart495586
Allen4040163
St. Joseph361083
Hamilton2887104
Vanderburgh205313
Hendricks1943108
Cass18069
Johnson1794119
Porter136239
Clark130750
Tippecanoe124511
Madison103066
LaPorte93530
Howard92065
Kosciusko87212
Floyd82249
Bartholomew82147
Marshall79423
Monroe76732
Delaware76052
Vigo71411
Dubois71312
Boone69746
Noble69029
Hancock68839
Jackson5975
Warrick58830
Shelby56828
LaGrange56610
Grant53130
Dearborn51628
Morgan48934
Clinton4504
Henry41820
Wayne38810
White37711
Montgomery36021
Lawrence35727
Harrison35224
Decatur34232
Putnam3218
Daviess27920
Miami2772
Scott27310
Jasper2572
Greene25434
Franklin24715
DeKalb2384
Gibson2334
Jennings22812
Steuben2153
Ripley2138
Carroll2003
Fayette1957
Perry18713
Posey1800
Starke1807
Orange17824
Wells1782
Fulton1732
Wabash1715
Jefferson1662
Knox1640
Whitley1566
Tipton14912
Washington1441
Sullivan1411
Spencer1393
Clay1315
Huntington1273
Randolph1274
Newton12110
Adams1172
Owen1051
Jay920
Rush894
Pulaski821
Fountain762
Brown752
Blackford662
Ohio656
Benton640
Pike620
Vermillion590
Parke551
Switzerland530
Martin500
Crawford450
Union410
Warren241
Unassigned0208

Ohio Coronavirus Cases

Data is updated nightly.

Confirmed Cases: 104248

Reported Deaths: 3734
CountyConfirmedDeaths
Franklin18965531
Cuyahoga13869512
Hamilton9844259
Lucas5512326
Montgomery448998
Summit3667224
Butler303364
Marion294245
Mahoning2623256
Pickaway240042
Stark1904142
Warren185039
Lorain183177
Columbiana168360
Trumbull1563110
Fairfield143232
Delaware136519
Licking134551
Clark121315
Lake114642
Wood109058
Clermont96211
Medina95936
Miami86839
Tuscarawas79714
Allen79446
Portage77664
Greene73012
Mercer64113
Belmont62726
Richland61912
Erie61028
Ashtabula57746
Geauga56144
Wayne55459
Ross5094
Madison50310
Darke41429
Huron4115
Ottawa40426
Sandusky39917
Hancock3973
Athens3612
Holmes3316
Lawrence3180
Auglaize2756
Union2731
Scioto2591
Muskingum2481
Jefferson2403
Seneca2344
Shelby2154
Knox2147
Preble2122
Putnam21217
Washington21122
Coshocton1967
Champaign1882
Morrow1792
Crawford1775
Hardin17512
Clinton1716
Highland1692
Logan1672
Ashland1553
Fulton1551
Defiance1544
Wyandot1519
Brown1502
Perry1483
Williams1373
Fayette1240
Henry1222
Hocking1229
Guernsey1197
Carroll1135
Monroe9418
Pike800
Jackson770
Gallia741
Van Wert732
Paulding700
Adams642
Meigs580
Vinton322
Morgan300
Harrison261
Noble170
Unassigned00
Fort Wayne
Clear
72° wxIcon
Hi: 86° Lo: 63°
Feels Like: 72°
Angola
Clear
72° wxIcon
Hi: 85° Lo: 63°
Feels Like: 72°
Huntington
Broken Clouds
72° wxIcon
Hi: 84° Lo: 62°
Feels Like: 72°
Decatur
Clear
72° wxIcon
Hi: 85° Lo: 62°
Feels Like: 72°
Van Wert
Clear
72° wxIcon
Hi: 85° Lo: 62°
Feels Like: 72°
Mostly Sunny Thursday
WFFT Radar
WFFT Temperatures
WFFT National

Community Events