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Death Row Inmates Challenge FDA on Execution-Drug Imports

Twenty-one death row inmates asked a U.S. judge to order the Food and Drug Administration to block importation and use of a drug administered in executions, saying the anesthesia for lethal injections hasn’t been properly vetted by the agency.

Lawyers for the inmates argued today in federal court in Washington that the FDA has violated the law by allowing state departments of corrections to import sodium thiopental, a drug used as a first-stage painkiller in the process of executing an inmate with a lethal injection.

“The harm here is that unapproved, illegal drugs from an unregistered, foreign establishment are going to be administered to our clients,” Bradford Berenson of Sidley Austin LLP in Washington told U.S. District Judge Richard Leon.

Berenson argued during a 1 1/2-hour-long hearing that the drug, which will be pumped into inmates’ veins as part of their executions, could lead to so-called anesthesia awareness. Arizona and California are two states that still have supplies of sodium thiopental and plan to use them, he said.

Gerald Kell, a lawyer for the Justice Department, urged Leon to dismiss the case, arguing the FDA’s enforcement decisions cannot be challenged in court.

“The FDA has unreviewable discretion not to bring an enforcement action,” Kell said.

FDA ‘Deference’

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 seeking dismissal of the case.

Leon didn’t say when he would decide the case.

“Whatever word I come up with will not be the last word,” Leon said, adding that he was a “way station on the road” to the U.S. Appeals Court in Washington.

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.

The inmates are seeking an injunction barring future imports of thiopental and the removal of supplies already in the possession of state governments.

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

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

The case is Beaty v. Food and Drug Administration, 11-cv-00289, U.S. District Court, District of Columbia (Washington).

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