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Texas Sues FDA Over Execution Drug Shipment

05.01.2017 -

The US state of Texas has filed a lawsuit against the Food and Drug Administration in the federal district court of Galveston, seeking to force the regulatory agency to agree to release an impounded shipment of the barbiturate sodium thiopental to the Texas prison system. It also has asked the court to declare unlawful the FDA-imposed delay of the shipment planned to be used for executions.

A 1,000-vial shipment of the drug purchased by the Texas Department of Criminal Justice from an unidentified foreign supplier was detained at Houston’s international airport in July 2015 and has remained in federal custody. In filing the lawsuit, the state’s attorney general, Ken Paxton, said the FDA should decide within a "reasonable" time. Sodium thiopental is no longer produced in the US.

Paxton suggested that the FDA’s sole reason for the delay was either “incompetence or willful obstruction," adding that the government body is “obliged to fulfill its responsibilities faithfully and in a timely manner” and not hinder the state in carrying out its law enforcement duties.

While the agency did not comment directly on the lawsuit, federal officials have repeatedly stated that sodium thiopental, which previously was part of a three-drug mixture used in Texas and other states for executions, has no legal uses in the US.

The prison system in states allowing capital punishment has found it difficult to obtain execution drugs as many pharmaceutical companies, fearing the wrath of death penalty opponents, have barred sales of their products for lethal injections. Many states have turned to alternative suppliers, with the lower quality of some of the drugs or their lack of suitability for the purposes leading to botched executions.

Several death penalty states have laws in place allowing suppliers of execution drug to remain anonymous. Texas, which has carried out more lethal injections than any other state, putting 548 people to death since 1982, implemented the pertinent legislation last year as did Mississippi and Virginia in 2016.  Arkansas, North Carolina, Texas and Wyoming passed laws in 2016.

In Nebraska, state officials in Nebraska launched a campaign to change the death penalty protocol to allow drug suppliers to remain anonymous. The state’s corrections director, who would have the power to choose which drugs are used under the proposed legislation could also withhold any records that could identify suppliers.

A quirk of the plans is that condemned inmates would have to be told which drugs were chosen at least 60 days before the attorney general's office requests an execution warrant. At that point, the drugs used would become a public record, although the supplier's identity could continue remain confidential.

At a public hearing on Dec. 30, pharmacists expressed concern that aspects of Nebraska’s proposed new protocol may violate existing state laws, in particular as the profession is not trained or licensed to compound lethal injection drugs in the way the corrections department would require. They also may not compound or administer drugs not prescribed by a physician.

Nebraska voters reinstated the death penalty in 2016 after abolishing it earlier, only to see the decision overridden by Governor Pete Rickets. In 2015, Nebraska reportedly paid more than $54,000 to India-based Harris Pharma to obtain execution drugs but did not receive FDA permission to import them.