Texas sues FDA to make decision on execution drug shipment

The barbiturate sodium thiopental previously was part of a three-drug mixture Texas used for executions

FILE - This Oct. 14, 2015, file photo shows the Food and Drug Administration campus in Silver Spring, Md. The FDA announced Monday, Dec. 12, 2016, that it denied the request by Swedish Match to remove several health warnings from its smokeless tobacco pouches, though regulators left open the possibility for other labeling changes it seeks. It's the first decision of its kind handed down by the agency since it gained authority to review the relative risks of tobacco products in 2009. (AP Photo/Andrew Harnik, File)

HOUSTON (AP) — Texas filed a lawsuit Tuesday against a federal agency to force it to decide whether an impounded shipment of a drug used for executions should be delivered to the Texas prison system, which has carried out more lethal injections than any other state.

A 1,000-vial shipment of sodium thiopental purchased by the Texas Department of Criminal Justice from an unidentified foreign drug supplier was detained in July 2015 at Houston Bush Intercontinental Airport. The drug package remains in federal custody.

The Food and Drug Administration should decide within a “reasonable” time and 17 months was not reasonable, Attorney General Ken Paxton said.

“There are only two reasons why the FDA would take 17 months to make a final decision on Texas’ importation of thiopental sodium: gross incompetence or willful obstruction,” Paxton said. “The FDA has an obligation to fulfill its responsibilities faithfully and in a timely manner. My office will not allow the FDA to sit on its hands and thereby impair Texas’ responsibility to carry out its law enforcement duties.”

An FDA spokeswoman, Lyndsay Meyer, said the agency “does not comment on possible, pending or ongoing litigation.”

Federal officials said previously the drug has no legal uses in the U.S.

Paxton said the FDA is withholding importation of the sodium thiopental based on allegations the drug violates new drug approval requirements. According to the lawsuit, however, Texas’ use of the drug falls within a “law enforcement” exemption, is not for patient use and is labeled as not for patient use. Paxton said it’s solely used by law enforcement as part of enforcing lawfully imposed capital sentences through lethal injection. 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.

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.

Texas, which has carried out 538 lethal injections since 1982, has been using the sedative pentobarbital for executions since 2012.

“We cannot speculate on the future availability 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,” Texas Department of Criminal Justice spokesman Jason Clark said Tuesday.

The barbiturate sodium thiopental previously was part of a three-drug mixture Texas used for executions.

In its lawsuit in federal district court in Galveston, the attorney general’s office asked the court to declare the FDA’s delay unlawful and compel the agency to decide whether to admit the drugs.

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