FDA finalizes refusal to give Texas execution drug shipment

Federal officials on Thursday finalized their refusal to allow Texas prison officials to receive a foreign shipment of a drug the state has used to execute death row inmates.

The refusal centers on a shipment of 1,000 vials of sodium thiopental detained by federal officials at Houston Bush Intercontinental Airport in July 2015. The drug was from an unidentified foreign drug supplier.

In a document filed Thursday in federal court in Galveston, the U.S. Food and Drug Administration said it “has made a final decision, refusing admission of the detained drugs into the United States.” The decision is based on the FDA view “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.

Federal officials have said the drug has no legal uses in the United States, but Texas Attorney General Ken Paxton’s office has sued for the drugs to be released.

Texas has carried out 542 lethal injections since 1982, including four this year, and has used the sedative pentobarbital for executions since 2012. The barbiturate sodium thiopental previously was part of a three-drug process Texas used for executions.

According to the lawsuit, the state’s use of the drug falls within a “law enforcement” exemption, is not for patient use and is labeled as not for patient use. The drug is solely used by law enforcement as part of enforcing lawfully imposed capital sentences through lethal injection, Paxton asserted. The lawsuit also pointed out the drug has been used for anesthetic purposes since before the Federal Food, Drug and Cosmetic Act was enacted in 1938.

The Texas Department of Criminal Justice, which operates the state prison system, is now considering its next move.

“It has taken almost two years for the Food and Drug Administration to reach a decision which we believe is flawed,” Jason Clark, a spokesman for the department, said in a statement. “TDCJ fully complied with the steps necessary to lawfully import the shipment. We are exploring all options to remedy the unjustified seizure.”

Corrections departments in death penalty states around the U.S. have had difficulties obtaining execution drugs since traditional drug manufacturers – many of them under pressure from capital punishment opponents – have barred sales of their products for lethal injection use. Texas prison officials have declined to provide any details about the state’s ordered drugs. A state law that took effect in September allows Texas to withhold the identity of its lethal injection drug provider.