Feds won’t return execution drugs to Texas

FDA says shipment impounded at Bush was not approved

The U.S. Food and Drug Administration has decided not to release an impounded shipment of drugs intended for the Texas Department of Criminal Justice, which had purchased them potentially for use in lethal injections of condemned inmates.

The shipment of sodium thiopental, an anesthetic, was seized at Bush Intercontinental Airport by authorities in 2015 because it is not approved for use in humans. Texas and Arizona had acquired an import license from the Drug Enforcement Administration, but that did not impress FDA officials. They filed documents in federal court Thursday stating it would not allow the state to take delivery.

In a later statement, an FDA spokesman said the “detained drugs appear to be unapproved new drugs and misbranded drugs. As such, the shipments must be exported or destroyed.”

Manufacturers of drugs used in executions have consistently argued against their use for capital punishment, but as long as the drugs were on the market in the U.S. and available for sale, there was little they could do to control distribution. As a result many companies decided to take them off the American market or quit manufacturing them, as with sodium thiopental.

Ever since, states across the country that impose the death penalty have had increasing problems acquiring drugs suitable for lethal injection, leading them to find unusual suppliers, sometimes including dubious operators in developing countries. The seized shipment came from a company in India that has been at the center of an unrelated controversy.

In order to protect those suppliers, most states, including Texas, no longer reveal the sources of their drugs. But even that has not assured a steady supply. Arkansas recently announced its intention to execute eight inmates in 10 days because of the looming expiration date of the drug it uses for lethal injections. Several of those executions have been placed on hold by appellate courts.

Texas has had better luck in maintaining its chemical arsenal. It claims to have adequate supplies of the drug it uses, pentobarbital, to meet its execution schedule. As to why it ordered the sodium thiopental, which was part of a three-drug combination used for decades by the prison system, a spokesman said it stemmed from concerns over the future availability of drugs. Sodium thiopental has not been used in a Texas execution since 2011.

The agency denounced the FDA decision.

“It has taken almost two years for the Food and Drug Administration to reach a decision which we believe is flawed,” TDCJ spokesman Jason Clark 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.”

Prison officials and some legislators have long contended that it was the actions of capital punishment opponents that led manufacturers to oppose the use of their drugs in lethal injections.

But most of those companies, including thiopental maker Hospira, have insisted they objected on ethical grounds to the use of the pharmaceuticals for off-label purposes.

Texas sued the FDA in January, with Attorney General Ken Paxton claiming the agency had engaged in an “unreasonable delay” in not coming to a definitive decision on the status of the shipment. Paxton argued that importing the drug was legal because it would be used for law enforcement purposes.