FDA to Texas and Arizona: Destroy or Export Detained Shipments of Execution Drugs

Posted 24 April 2017 By Zachary Brennan

placeholder+image

After a lengthy wait, the US Food and Drug Administration (FDA) has officially told Texas and Arizona that their imported execution drugs cannot be used because they were unlawfully obtained.

FDA spokesperson Lyndsay Meyer told Focus via email: “The FDA has notified the Texas Department of Criminal Justice and the Arizona Department of Corrections that their detained shipments of sodium thiopental have been refused on the basis that the detained drugs appear to be unapproved new drugs and misbranded drugs. As such, the shipments must be exported or destroyed.”

Both states now have 90 days to export or destroy their respective detained shipments of sodium thiopental.

Jason Clark, director of public information at the Texas Department of Criminal Justice (TDCJ), told Focus via email: “It has taken almost two years for the Food and Drug Administration to reach a decision which we believe is flawed. TDCJ fully complied with the steps necessary to lawfully import the shipment. We are exploring all options to remedy the unjustified seizure.”

Background

As Focus has reported since 2012, FDA has a complicated history with execution drugs, particularly sodium thiopental, which can be used alone or as part of a cocktail to execute inmates on Death Row.

Issues with the drug began in 2011, when the only approved version of the drug, Abbott's sodium thiopental, was discontinued after the company said it did not want to produce an execution drug.

Then in 2012, FDA was barred from allowing the importation of an anesthetic used in executions.

Meyer explained that FDA previously exercised enforcement discretion regarding the importation of sodium thiopental used for lethal injection.

“But in 2012 the United States District Court for the District of Columbia issued an order that permanently enjoins the agency from ‘permitting the entry of, or releasing any future shipments of, foreign manufactured thiopental that appears to be misbranded or in violation of 21 U.S.C. [§] 355 [as an unapproved new drug].’ As such, the court order requires the FDA to refuse admission to the U.S. any shipment of foreign manufactured sodium thiopental being offered for importation that appears to be an unapproved new drug or a misbranded drug,” she said.

Following that order, in July 2015, FDA halted shipments of sodium thiopental to Texas and Arizona, though both states have lobbied to persuade FDA that impounding the imports is illegal.

Other states, such as Georgia, have been accused of executing inmates inhumanely because some of the newer cocktails of lethal injections have taken longer than expected, while other states, like Montana, have to deal with court rulings finding that certain drugs do not meet state execution standards.

Share this article:

Categories: Drugs, Crisis management, Due Diligence, News, US, FDA

Tags: sodium thiopental, execution drugs, FDA and state executions, misbranded drugs

Regulatory Exchange: Latest Updates From the Community