USA - Federal judge bars import of execution drug.

Federal judge bars import of execution drug. U.S. District Judge Richard Leon in Washington issued the 22-page decision in a case filed by 21 condemned convicts against the federal Food and Drug Administration, which they alleged had violated its own rules by allowing entry of the powerful anaesthetic into the United States without first ensuring its efficacy. “Prisoners on death row have an unnecessary risk that they will not be anesthetized properly prior to execution,” Leon wrote in his order. In his order, Leon ordered five states — Arizona, California, Georgia, South Carolina and Tennessee — and any others with stocks of the barbiturate to surrender them to the FDA. According to court filings, the shipments of thiopental entering the United States came from an Austrian facility owned by Sandoz International GmbH. The drug was shipped from a London wholesaler, Dream Pharma Ltd., which purchased it from a third firm, the Britian-based Archimedes Pharma Ltd., the filings state. In court filings, FDA officials had argued that their decision to allow the drugs to enter the United States was an act of “enforcement discretion,” insisting that for them to review drugs used in lethal injections carried out by states was outside their public health role as an agency. The Obama administration argued it had discretion to allow unapproved drugs into the U.S. Leon disagreed, saying that because the agency had not reviewed thiopental for safety or effectiveness its importation violated the federal Food, Drug and Cosmetic Act. Sodium thiopental is an anesthetic used to put inmates to sleep before other lethal drugs are administered. The drug's U.S. manufacturer announced last year that it would no longer produce it, which forced corrections officials to delay many executions. Many of the nation's 34 death penalty states switched to an alternative drug, pentobarbital — a point Leon stressed. A lawyer for the death row challengers, Brad Berenson, said in an email that "it was especially gratifying that the court recognized that even the most despised members of our society are entitled to the protections Congress gave to all Americans in the Food Drug and Cosmetic Act." The FDA declined to comment on the ruling or say whether it planned to appeal. Leon, who was appointed by President George W. Bush, dismissed the FDA's contention that the death row inmates lacked standing. "Here, the threatened injury — that unapproved foreign thiopental will fail to anesthetize plaintiffs properly during execution, causing conscious suffocation, pain, and cardiac arrest — is, to say the least, severe," the judge wrote. "Indeed, few in our society are more vulnerable than a death row inmate facing lethal injection." Leon also said that the FDA was undermining its own policy of maintaining a closed drug distribution system designed to keep dangerous drugs out of U.S. commerce. "By opening up the 'closed' drug system by allowing an unapproved drug — thiopental — into the United States, defendants jeopardize their own system and threaten the public health by creating a risk that thiopental could incorrectly end up in the hands of the general public," he wrote. (see also Feb. 3, 2011, Feb. 9, 2012, March 15, 2011 and April 1 and 21, 2011).