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FDA to Ohio: Plan to get new execution drug overseas illegal

Created: 08/19/2015 4:52 PM KAALtv.com
By: By JULIE CARR SMYTH

COLUMBUS, Ohio (AP) — A federal agency has warned Ohio that the state would be breaking the law if it carried out plans to import lethal injection drugs from overseas.

The U.S. Food and Drug Administration informed Ohio prisons director Gary Mohr of its legal concerns in a June letter, released Wednesday after BuzzFeed reported receiving it through a public records request.

The communication came after Ohio announced earlier this year that it intended to obtain supplies of sodium thiopental to replace the two-drug combination used in a troubling 2014 execution. The state halted use of a mix of midazolam, a powerful sedative, and hydromorphone, a painkiller, after Ohio's first-in-the-nation try with the drugs caused convicted killer Dennis McGuire to repeatedly gasp and snort in a 26-minute lethal injection procedure.

No executions are scheduled in Ohio this year as the prisons agency looks for supplies of either pentobarbital or sodium thiopental — powerful sedatives it has used in the past but which are virtually unavailable in any form except compounded. The state has set 21 execution dates beginning early next year and stretching into 2019.

Sodium thiopental is no longer available in the U.S. and overseas imports were subject to importing bans. Still, the prison where Ohio carries out executions successfully applied for an import license from the U.S. Drug Enforcement Administration late last year in its search for lethal injection drugs. The license expires in February 2016.

Domenic Venziano, FDA import operation director, wrote Mohr that importing from overseas isn't allowable.

"Please note that there is no FDA approved application for sodium thiopental, and it is illegal to import an unapproved new drug into the United States," Venziano wrote.

JoEllen Smith, a spokeswoman for the Ohio Department of Rehabilitation and Correction, said Mohr sent no reply.

"DRC continues to seek all legal means to obtain the drugs necessary to carry out court-ordered executions," she said in an email. "This process has included multiple options."

The FDA declined to elaborate on what specifically prompted the letter.

"At this time, we have no indication that sodium thiopental has recently been imported into the United States by Ohio state officials or the correctional system," senior adviser Jeff Ventura said. "With very limited exceptions, it is unlawful to import this drug and FDA would refuse its admission into the United States."

Diann Rust-Tierney, executive director of the National Coalition to Abolish the Death Penalty, said as use of the death penalty wanes, efforts to keep it going get "more and more bizarre."

"It's unsettling when you have the government, which is supposed to be upholding the law and doing something, in theory, that's supposed to be showing respect for the law, and then there's a question of whether they're following the law," she said. "It's another example of this quandary the death penalty puts us in."

Ohio Public Defender Tim Young said he respects Mohr and believes he and the department want executions to be conducted "as cleanly as they can."

"Functionally, it can never be achieved under the system that requires them to have nonprofessionals using drugs from gray markets or markets that you should never be obtaining drugs from," he said.

(Copyright 2015 by The Associated Press. All Rights Reserved.)