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Ohio Challenges FDA’s Stand on Execution Drug

By Pharmaceutical Processing | October 9, 2015

With two dozen scheduled executions in limbo, Ohio sent a forceful letter to Washington on Friday asserting that the state believes it can obtain a lethal-injection drug from overseas without violating any laws.

The letter to the FDA stopped short of suggesting Ohio is moving forward to obtain the powerful anesthetic sodium thiopental. However, the state asked to begin discussing with federal officials about acquiring the substance legally.

The FDA had warned Ohio in June that importing the restricted drug could be illegal as a result of recent federal court decisions, setting up the latest roadblock to carrying out the death penalty.

Ohio has not executed anyone since January 2014, when condemned killer Dennis McGuire gasped and snorted repeatedly during a 26-minute procedure with a two-drug method that had yet to be tried. Ohio abandoned that method in favor of other drugs it now ca not find.

Pharmaceutical companies have discontinued the medications traditionally used by states in executions or put them off limits for use in lethal injections.

Stephen Gray, Chief Counsel for the Ohio Department of Rehabilitation & Correction, said the state has no intention of violating the law to obtain such drugs, but “the responsibility to carry out lawful and humane executions when called upon by the courts to do so is enormous, and it is a responsibility that ODRC does not take lightly.”

Death penalty opponents have seized on trouble with lethal injections, as in McGuire’s case, and difficulty in obtaining drugs as further justification for ending it. Supporters of capital punishment encourage states to continue to pursue legal avenues for getting the drugs—or find alternatives—so that condemned killers can be brought to justice.

Ohio’s latest correspondence comes as the state is set to resume executions in a little over three months.

After reviewing the court decisions cited in the FDA’s warning letter, Gray said he believes Ohio would be able to legally import sodium thiopental as long as it follows a five-step process for obtaining the drug: that it comes from an FDA-registered source; is on that source’s list of drugs in commercial distribution in the U.S.; is not misbranded; is not adulterated; and is in a shipment examined by the FDA.

Doug Berman, an Ohio State University law professor and death penalty expert, said it remains unclear whether the FDA’s injunctions in the realm of execution drugs are legally justifiable.

“My sense is that the Food and Drug Administration, both from Congress’ perspective and others, was never designed to create an additional impediment to states trying to carry out lawful sentences,” Berman said.

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