May 23, 2018
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FDA appeals court ruling that bans drug used in executions

Sodium thiopental is used in 34 states prior to executions.
By Tom Schoenberg, Bloomberg News

The Food and Drug Administration is appealing a federal judge’s order that banned the importation of sodium thiopental and its use in executions.

The FDA, which filed a notice of appeal Friday in the federal court in Washington, is seeking to overturn a ruling in March favoring 21 death row inmates who challenged the agency’s use of sodium thiopental, an imported drug given as anesthesia before a lethal injection is administered.

U.S. District Judge Richard Leon held that the agency violated its own rules by allowing the drug into the country without first ensuring its effectiveness. Leon said the agency created “an unnecessary risk” that prisoners “will not be anesthetized properly prior to execution.”

Leon said the agency had created a “slippery slope” for the entry of other unapproved drugs.

The judge banned the import of thiopental, calling it a misbranded and unapproved drug, and directed Arizona, California, Georgia, South Carolina and Tennessee and any others with stocks of the barbiturate to send them to the FDA.

On May 21, 15 state attorneys general sent Attorney General Eric Holder a letter urging the department to appeal Leon’s ruling. The legal officers said the case was wrongly decided and might impair states’ ability to execute prisoners.

In a lawsuit filed in February 2011, the inmates said the FDA allowed states to import “bulk amounts” of thiopental. The drug hasn’t been sold in the U.S. since 2009, when the sole U.S. manufacturer, Hospira Inc., stopped producing it.

Shelly L. Burgess, a spokeswoman for the FDA, declined to comment on the agency’s plan to appeal.

“The D.C. Circuit should be no more inclined than the district court to allow FDA to permit unapproved, illegal drug products into the United States where Congress has expressly said it can’t,” a lawyer for the inmates, Bradford Berenson of Sidley Austin in Washington, said in an email.

The shipments of thiopental entering the United States originated from an Austrian facility owned by Sandoz International, a German company, according to the complaint. The drug was shipped to the United States from a London wholesaler, Dream Pharma, the inmates said.

Dream Pharma bought the drug from a unit of Archimedes Pharma, a closely held company based in Reading, Britain, according to the complaint.

Allowing thiopental into the U.S. conforms with the FDA’s public-health mission, enforcement priorities and “deference to law enforcement” on capital punishment matters, the Justice Department said in a filing before Leon’s ruling.

The FDA said the release of the imported drug within the U.S. was an act of enforcement discretion, and that “reviewing substances imported or used for the purpose of state-authorized lethal injection clearly falls outside of FDA’s public health role,” according to Leon’s ruling.

The judge heard arguments from both sides on Feb. 9.

Leon said there was no dispute that the FDA hadn’t reviewed foreign or domestic thiopental for safety and effectiveness. Because it was unapproved, the federal Food, Drug and Cosmetic Act required the agency to bar its import, he said.

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