FDA again blocks Texas execution drug


Additional material from staff writer Jonathan Tilove.

The U.S. Food and Drug Administration has once again blocked Texas prison officials from importing a drug intended for executions, setting back state efforts to ensure an adequate supply of lethal injection drugs.

Problems began for Texas last fall, when the FDA seized overseas shipments of sodium thiopental even though Texas and Arizona had acquired import licenses from the U.S. Drug Enforcement Administration.

At the time, FDA spokesman Jeff Ventura said the agency was relying on court opinions that determined that “sodium thiopental for the injection in humans is an unapproved drug and may not be imported into the country.”

Texas officials appealed the seizure through an internal FDA process but recently learned, via letter, that the federal agency had rejected those efforts.

Jason Clark, spokesman for the Texas Department of Criminal Justice, said the FDA’s decision was preliminary, adding that the prison agency was “exploring its options moving forward regarding the lawful importation of drugs used in the lethal injection process.”

An FDA spokesman declined to comment on the letter Tuesday, saying, “This remains an ongoing proceeding.”

The availability of execution drugs has tightened as manufacturers in the United States and overseas, fearing negative publicity, have stopped making or selling drugs commonly used for lethal injection. The only U.S. maker of sodium thiopental, for example, stopped selling the drug in 2011, saying it did not want the drug used in executions.

Later that year, Texas stopped using sodium thiopental, a fast-acting anesthetic, as part of a three-drug protocol for executions.

In 2012, prison officials switched to a single dose of pentobarbital, which suppresses brain function and stops breathing — a method Texas continues to use.

In addition to seeking alternate sources of execution drugs, Texas officials have taken steps to reassure potential suppliers by acting to keep their identities secret.

Much of that effort stemmed from events in October 2013, when the pharmacist in charge of The Woodlands Compounding Pharmacy near Houston demanded that Texas return 16 vials of pentobarbital, citing a “firestorm” that erupted after the pharmacy’s identity was revealed under open records laws.

Prison officials refused the pharmacy’s request, then increased efforts to keep subsequent drug suppliers secret.

In April 2014, a federal judge in Houston blocked the executions of two death row inmates, ruling that defense lawyers could not properly challenge the planned use of a new batch of pentobarbital without knowing the source of the drug and what tests had been performed to assure its effectiveness.

Within hours, however, the 5th U.S. Circuit Court of Appeals overruled the judge, saying defense lawyers needed more than speculation that the new drugs could be inferior or cause risk of severe pain in inmates.

Both inmates were executed as scheduled.

One month later, then-Attorney General Greg Abbott said prison officials must keep the identity of execution drug suppliers secret, reversing previous rulings from his office that said the information must be disclosed under the Texas Public Information Act.

Revealing the drug supplier’s name would place the manufacturer or pharmacist at substantial risk of “physical harm,” Abbott’s office said in a letter to prison officials.

After his election as governor, Abbott in 2015 signed into law a bill that bars state agencies from disclosing the identity of any company or person who manufactures, tests, procures or provides an execution drug.

That was not the end of the controversy, however.

On May 5, the Austin-based 3rd Court of Appeals will hear oral arguments on a public information request that was filed before the nondisclosure law took effect Sept, 1, 2015.

Prison officials appealed an order from state District Judge Darlene Byrne, who told them to identify the state’s pentobarbital supplier to three lawyers who represent death row inmates.

Lawyers for Attorney General Ken Paxton argue that Byrne’s order, if allowed to stand, would undermine a Texas Supreme Court ruling that allowed typically public information to be kept secret if disclosure would be a safety risk.

The lawyers — Maurie Levin, Naomi Terr and Hilary Sheard — argue that Texas has presented only vague concerns about retaliation against drug suppliers, falling far short of proving a substantial threat of physical harm as required by the Supreme Court.

Additional material from staff writer Jonathan Tilove.


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