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California says it shouldn't have to return foreign-bought execution drug to FDA

California's lethal injection chamber at San Quentin State Prison.
California's lethal injection chamber at San Quentin State Prison.

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The California Department of Corrections and Rehabilitation is arguing that it doesn't have to give up its stock of the lethal injection drug sodium thiopental to the federal government. In a letter dated May 1, 2012, CDCR General Counsel Benjamin Rice told Domenic Veneziano, director of the FDA's Division of Import Operations and Policy, that "CDCR must decline to return the thiopental in its possession at this time."

The letter was in response to the FDA's order in April that states that imported the execution drug from abroad stop using them and return them to the FDA. 

The drug, sodium thiopental, is an anesthetic used by many states as an execution drug. In California, the drug is the first of three used — the condemned inmate is first put to sleep using thiopental, then given a paralyzing drug, followed by a third drug that stops his or her heart.

In 2010, the US experienced a massive shortfall in sodium thiopental supplies because the sole US manufacturer lacked a necessary ingredient. That firm, Hospira, was also the only source of the drug approved by the FDA. The company has since completely abandoned making the drug, as it had always objected to its use in executions.

Amidst this scarcity, California and several other states purchased sodium thiopental from a company in the United Kingdom. Some have used the drug in executions. At the time, the FDA, did not interfere with the states importing the drug.

In April of this year, following a lawsuit by death row inmates, the FDA issued a letter ordering the states that bought foreign drugs to return their supplies to the agency. The inmates had argued the drugs had not been reviewed for their effectiveness. If the drug didn't work properly, they argued, they could experience severe pain during an execution, a violation of the Eight Amendment's ban on cruel and unusual punishment. 

The CDCR, in its May 1 letter, the CDCR urged the FDA to appeal the ruling in the death row inmates' suit, Cook v. FDA. The FDA apparently agrees. On Friday, the agency filed papers in federal court to appeal the ruling's ban on importing foreign sodium thiopental. 


Domenic Veneziano FDA

Audio: KPCC's Julie Small on the decision.