Regulatory Focus™ > News Articles > FDA Still Reviewing Arizona, Texas Claims on Importing Execution Drugs

FDA Still Reviewing Arizona, Texas Claims on Importing Execution Drugs

Posted 07 December 2015 | By Zachary Brennan 

FDA Still Reviewing Arizona, Texas Claims on Importing Execution Drugs

Arizona and Texas continue to battle with the US Food and Drug Administration (FDA) over the legality of importing drugs used in executions, more than two years after a Court of Appeals said the agency cannot allow the imports.


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 intended to execute inmates on Death Row.

Issues with the drug began back in 2011, when the only approved version of the drug, Abbott's Pentothal, 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, and then a year later the DC Court of Appeals ruled that FDA could no longer use its enforcement discretion to allow execution drugs to be imported.

And now, as states turn to drug compounders and other foreign manufacturers, FDA is revisiting the issue, particularly as some states believe they can in some instances import execution drugs legally.

The stakes are particularly high, as a number of states have had to postpone executions because they still don’t have enough supplies of executions drugs, including sodium thiopental and pentobarbital, which is another drug that manufacturers are hesitant to provide to state corrections departments.

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 pentobarbital does not meet state execution standards.

Similarly, Nebraska attempted to import other execution drugs from a small Indian manufacturer, though the unapproved drugs never made it out of India and the state has since decided to hold off on any executions until a referendum on capital punishment in 2016.

And in Ohio, according to a 9 October letter to Capt. Domenic Veneziano, director of FDA’s Division of Import Operation, Ohio’s Department of Rehabilitation and Correction is contending that contrary to FDA’s belief, prior court decisions do not “completely prohibit the importation of sodium thiopental.”

The department claims that such importations should be considered legal if the source of the sodium thiopental is FDA-registered (ie. Subject to FDA regulation and inspection), appears on the list of drugs commercially distributed in the US (which is currently not the case for any sources of sodium thiopental), and it’s not misbranded or adulterated or in violation of any other shipping regulations.

Arizona and Texas

In July, FDA halted the shipments of sodium thiopental to Texas and Arizona, though both states have spent the last five months trying to persuade FDA that impounding the imports is illegal. Since late October, FDA has been evaluating the states’ appeals.

“FDA is still reviewing documents submitted by the states of Arizona and Texas that set forth their legal argument,” FDA spokesman Chris Kelly told Focus on Friday.

Texas Department of Criminal Justice spokesman Jason Clark previously told the AP that the state legally purchased the drugs after obtaining an import license from the US Drug Enforcement Administration before the drugs were shipped, and notified FDA and customs of the shipment.

The issue remains particularly contentious, as Texas, which has 317 inmates on death row and enough lethal injection to execute two of them, recently moved to use compounding pharmacies, like Georgia, to supply versions of pentobarbital, though none of the manufacturers of any of these drugs want to be revealed publicly.

When the State Attorney General of Texas was asked to provide more information on those compounders, the attorney general told the court: “Defendants reasonably believe that they cannot obtain the (3) master formulation record and (4) certificate of analysis for the on-hand lethal injections. Defendants also reasonably believe that additional attempts to obtain such documentation will lead to termination of services necessary to carry out lawful sentences.”

Similarly, in Arkansas, a judge last Thursday sided with inmates in saying that the state’s execution law cannot keep secret the manufacturers of lethal injection drugs though the state did not have to immediately reveal its source.

And in Arizona, executions have been halted after the last executed inmate received 15 doses of midazolam and a painkiller, though the man was expected to die after one dose. Most recently, however, Arizona says it has supplies of midazolam, vecuronium bromide and potassium chloride and plans to move ahead with its executions.

FDA’s decision with Arizona and Texas should set a precedent for other states grappling with the issue, though it’s likely to also lead to more litigation.


© 2021 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.