Six death row inmates asked a U.S. judge to order the Food and Drug Administration to block importation of a drug used in executions, saying the anesthesia for lethal injections hasn’t been properly vetted by the agency.
The lawsuit, filed today in federal court in Washington, challenges the FDA on imports of thiopental sodium, a drug used as a first-stage painkiller in process of executing an inmate with a lethal injection.
“Over the course of the past six to 12 months, several state departments of corrections have imported unapproved, misbranded, and adulterated thiopental in violation” federal law and FDA regulations, the death row inmates alleged.
The suit said the FDA allowed states to import “bulk amounts” of thiopental, which 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 complaint claimed. Dream Pharma bought the drug from a unit of Archimedes Pharma Ltd., a privately held company based in Reading, U.K., the inmates said in the complaint.
Charles Miller, a Justice Department spokesman, declined to comment, saying the department hadn’t seen the complaint. Karen Riley, an FDA spokeswoman, did not immediately return a phone message and e-mail seeking comment.
The case is Beaty v. Food and Drug Administration, 11-cv- 00289, U.S. District Court, District of Columbia (Washington).
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