Texas sues FDA over lethal injection drugs confiscated in 2015

Texas officials filed a federal lawsuit Tuesday seeking to get a final answer about whether the U.S. Food and Drug Administration will hand over lethal injection drugs that the agency confiscated nearly a year and a half ago.

The lawsuit is seeking to force the FDA to make a decision about whether the batch of drugs – typically used to knock out inmates during executions – can be admitted into the country, according to a complaint filed by the office of Texas Attorney General Ken Paxton.

This complaint comes as states nationwide have scrambled to obtain lethal injection drugs, which in recent years have become increasingly difficult for officials to obtain. After the complaint was filed, Paxton argued that the FDA was hobbling the state’s law enforcement efforts.

“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 in a statement. “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.”

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The FDA declined to comment about the lawsuit, which you can read here.

Paxton’s office is representing the Texas Department of Criminal Justice, the state agency tasked with carrying out executions in the country’s most active death-penalty state. A spokesman for the department told The Washington Post that no executions in Texas have been prevented due to the drug being detained by federal officials.

Back in 2011, Texas officials switched their lethal injection protocol after being unable to obtain doses of sodium thiopental, the anesthetic at the heart of the state’s squabble with the FDA. As a result, the state switched to pentobarbital, a barbiturate used in most of the country’s executions since 2011.

States nationwide have struggled to obtain lethal injection drugs recently, due in part to European objections to the death penalty. Drug companies have also argued against the use of their chemicals in executions, including Pfizer, which last May tightened its restrictions to further make sure they cannot be used in lethal injections.

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According to the complaint filed Tuesday, an unnamed “foreign distributor” shipped 1,000 vials of sodium thiopental to the Houston airport in July 2015. (The lawsuit, and Paxton’s statement, refers to the drug as “thiopental sodium.”)

These drugs were examined by the FDA and detained by the agency, then by the U.S. Bureau of Customs and Border Protection, which stated in a detention notice that the vials were being held at the FDA’s request, the lawsuit states. In April 2016, the FDA reportedly told Texas officials it was tentatively barring them from importing the drug. However, Texas authorities argued that the drug did not violate any of the statutes cited by the FDA.

In the lawsuit, Paxton’s office argues that the FDA’s failure to release a final decision “directly harms, and unfairly prejudices,” the Texas Department of Criminal Justice by keeping the agency from using drugs it “has purchased and owns” to carry out lethal injections.

“The Texas Department of Criminal Justice lawfully ordered and obtained the necessary license to import drugs used in the lethal injection process, yet the Food and Drug Administration stopped the shipment and continues to hold it without justification,” Jason Clark, a department spokesman, said in a statement. “This has left the agency with no other recourse than to challenge the unjustified seizure in court.”

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Texas was on the verge of running out of pentobarbital in 2015, officials said, but wound up obtaining more. Officials there have not said where they obtained the chemicals, only identifying the supplier as a pharmacy that can compound drugs.

The state has enough drugs to carry out all of the currently executions, Clark said Tuesday. There are nine executions scheduled over the next six months.

Executions nationwide have plummeted recently, falling last year to the lowest total in a quarter-century. While some states have been unable to locate lethal injection drugs, others have delayed executions due to legal fights, uncertainty surrounding their statutes or logistical issues. In Texas, far and away the country’s leading practitioner of capital punishment, a series of court actions delayed several executions last year, resulting in the state carrying out seven lethal injections, its fewest in two decades.