FDA Warns Ohio Not to Illegally Import Execution Drugs

Ohio prisons officials, scrambling to find drugs for the next execution just five months away, had the door slammed on obtaining them from foreign sources.
by | August 21, 2015 AT 12:00 PM

By Alan Johnson

Ohio prisons officials, scrambling to find drugs for the next execution just five months away, had the door slammed on obtaining them from foreign sources.

A U.S. Food and Drug Administration official wrote June 26 to Gary Mohr, director of the Ohio Department of Rehabilitation Correction, warning him the agency would be breaking the law if it bought execution drugs overseas.

Domenic Veneziano, the federal agency's director of import, said the FDA learned the state " intends to obtain bulk and finished dosage forms of sodium thiopental. Since sodium thiopental is not available in the United States, we assume the product would be obtained from an overseas source."

"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." The FDA sent a similar letter to Nebraska officials in May.

Ohio prisons spokeswoman JoEllen Smith confirmed receipt of the letter, but said the state did not follow through with an overseas purchase. She acknowledged the state does not yet have drugs for the next execution.

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

The fact the state has not procured execution drugs means a new law, passed by the General Assembly and effective earlier this year, may not be working as expected.

The law allows prisons to buy drugs under secret contracts with "compounding pharmacies" without public disclosure of the source. Compounding pharmacies are typically smaller businesses which mix ingredients to user specifications. There are more than 1,000 such pharmacies in Ohio, but only a fraction of them mix injectible drugs.

The law was criticized by the Ohio Newspaper Association among others for hiding important public business behind closed doors.

Ohio Public Defender Tim Young slammed the overseas pharmaceuticals plan as "an obviously illegal attempt to obtain drugs in a way that is banned for every other American."

"This certainly supports the idea they are at the end of the available options for lethal injection drugs," Young said.

The latest development comes five months before Ohio's scheduled execution of Ronald Phillips of Summit County on Jan. 21, 2016. Another 20 executions have been set through May 2019.

Ohio's last execution was Jan. 16, 2014, when Dennis McGuire struggled and gasped for several minutes before succumbing to a combination of midazolam, a sedative, and hydromorphone, a morphine derivative. The drugs had never been used in combination for an execution anywhere in the U.S. Prison officials subsequently abandoned using those drugs.

Sodium thiopental is no longer available for purchase in the U.S. The last domestic manufacturer stopped production in 2011, largely because states were using it for executions.

Ohio's revised execution policy calls for using large doses of sedatives, either sodium thiopental or pentobarbital. Previous policies included using one to three drugs.

(c)2015 The Columbus Dispatch (Columbus, Ohio)