Three thousand vials of the anesthetic sodium thiopental that three states attempted to illegally import into the United States for use in executions have now expired, according to an investigative report by BuzzFeed News. Arizona, Nebraska, and Texas each purchased 1000 vials of the drug in 2015 from a questionable supplier in India called Harris Pharma, despite warnings from the Food and Drug Administration (FDA) that importation of the drug would violate federal law.
Citing documents obtained from the FDA through a public records request, BuzzFeed reports that the sodium thiopental in the shipments expired in May 2017.
The FDA confiscated the sodium thiopental Arizona and Texas attempted to bring into the country after U.S. Customs and Border Protection agents seized the shipments at airports in Phoenix and Houston. Federal officials justified their action saying that a 2012 court order “requires the FDA to refuse admission to the US any shipment of foreign manufactured sodium thiopental being offered for importation that appears to be an unapproved new drug or a misbranded drug.” FedEx halted Nebraska’s shipment in India because of “improper or missing paperwork.”
Harris Pharma, the company that sold the drugs, claimed to have manufactured the sodium thiopental itself, but the facilities it registered with the FDA and the Drug Enforcement Administration were not equipped to produce pharmaceuticals. Harris had, in fact, purchased the drug from another Indian manufacturer and resold it to the three states at a substantially inflated price.
The sole U.S. manufacturer of sodium thiopental halted production in 2011 over ethical concerns about the use of the product in executions.
In January 2017, Texas sued the FDA in federal court over the agancy’s continued detention of the drugs without having issued a formal decision on the disposition of the drugs. The FDA issued a final order in April 2017 refusing to release the drugs to Arizona and Texas, and Texas has challenged that ruling.
A spokesperson for the Texas Department of Criminal Justice said the state’s lawsuit against the FDA would continue, despite the expiration of the drugs. Last year, a Texas official whose name was redacted from official documents said in an affidavit that the state, “intends to continue importing thiopental sodium from the same foreign source, and with the same labeling, as the entry that FDA is currently detaining.”
Chris McDaniel, “Texas’s Illegal Execution Drugs From India Have Expired. It Plans To Buy More.,” BuzzFeed News, June 29, 2017. See Lethal Injection.