GALVESTON, Texas (CN) – As outrage over Arkansas’ speedy execution schedule exposed one drug company’s revulsion to capital punishment, the Food and Drug Administration said it won’t turn over 1,000 vials of an execution drug Texas imported two years ago.
The Texas Department of Criminal Justice ordered the vials of thiopental sodium, an anesthetic that can induce hypnosis in 30 seconds, in July 2015 from an unnamed foreign distributor and they arrived at Bush Intercontinental Airport in Houston the same day, court records show.
The FDA sent Texas notice in August 2015 it had seized the vials because it had not approved a “new drug application” for the shipment.
Texas has executed more prisoners than any state since the U.S. Supreme Court lifted a four-year ban on the death penalty in 1976. It sued the FDA in January seeking a declaratory judgment that the agency had illegally delayed issuing a final decision on whether to approve the drug.
The FDA denied Texas access to the drug in a final decision made Thursday.
“The FDA has notified the Texas Department of Criminal Justice and the Arizona Department of Corrections that their detained shipments of sodium thiopental have been refused on the basis that the detained drugs appear to be unapproved new drugs and misbranded drugs. As such, the shipments must be exported or destroyed,” FDA spokeswoman Lyndsay Meyer said in a statement.
She added: “In 2012 the United States District Court for the District of Columbia issued an order that permanently enjoins the agency from ‘permitting the entry of, or releasing any future shipments of, foreign manufactured thiopental that appears to be misbranded or in violation of 21 U.S.C. [§] 355 [as an unapproved new drug].’” (Brackets in original.)
Texas has 90 days to export or destroy its detained shipment of thiopental sodium, Meyer said Friday in an email.
The Texas Department of Criminal Justice on Friday said it is determined to get the drugs.
“It has taken almost two years for the Food and Drug Administration to reach a decision which we believe is flawed. TDCJ fully complied with the steps necessary to lawfully import the shipment. We are exploring all options to remedy the unjustified seizure,” TDCJ spokesman Jason Clark said in a statement.
The Texas Attorney General’s Office didn’t immediately respond Friday when asked if Texas will file a petition for review with the D.C. Circuit, which hears appeals of federal agency decisions.
Though Texas has used only pentobarbital – a barbiturate prescribed to treat insomnia and used as an emergency treatment for seizures – in its more than 30 executions since 2012, and for all four prisoners it has put to death so far this year, Clark has said the state likes to be well-prepared for capital punishment.
“We cannot speculate on the future availability of drugs, so the agency continues to explore all options, including the continued use of pentobarbital or alternate drugs to use in the lethal injection process,” Clark told the Associated Press in January in response to questions about Texas’ lawsuit against the FDA.
Texas has enough pentobarbital for all its scheduled executions, Clark said in an email Friday. Texas has five more prisoners set for lethal injections in 2017 and has not scheduled any more for upcoming years.
Texas included thiopental sodium in a three-drug cocktail it used to kill prisoners before large drug manufacturers, unwilling to play a part in the death penalty, stopped producing the drugs the state used, forcing it to buy pentobarbital from a compounding pharmacy.
McKesson Medical-Surgical Inc. showed its distaste for the death penalty when it intervened in Arkansas’ plan to execute eight men over 11 days before its supply of midazolam, an anesthesia and sleep aid, expires at the end of April.
McKesson recently filed two lawsuits against the Arkansas Department of Corrections, alleging the DOC lied that the vecuronium, a muscle relaxant, it ordered from the San Francisco-based company would be used for medical treatment of prisoners, not to execute them.
Though legal challenges have stopped four of the executions Arkansas planned to carry out before May, the state executed Ledell Lee on Thursday night. Lee, a 51-year-old African-American, was the first prisoner Arkansas executed since 2005.
Arkansas plans to execute two more prisoners April 24 and a third April 27.
Asked on Friday if the Texas Department of Criminal Justice orders drugs from McKesson for medical or execution purposes, its spokesman said, “We have publicly stated that pentobarbital on hand comes from a pharmacy that has the ability to compound.”