Shortage of sodium thiopental for lethal injection

The shortage of sodium thiopental for lethal injection continues, and the US response to the shortage has progressed beyond that in my previous post below. First, a reminder that there is no FDA-approved source of injectable sodium thiopental. Any sodium thiopental imported for health care is an illegal substance. In contrast, the FDA has not acted on importation of thiopental for lethal injection. Beaty et al. v FDA has challenged this inaction in federal court and yesterday US District Judge Richard Leon banned the import of thiopental for lethal injection and ordered the states to return any supplies obtained abroad. Reuters quotes from Judge Leon's written opinion:

"The FDA appears to be simply wrapping itself in the flag of law enforcement discretion to justify its authority and masquerade an otherwise seemingly callous indifference to the health consequences of those imminently facing the executioner's needle. How utterly disappointing!"

Here is a PDF of the judge's order accompanying his opinion. The APA reference in the order is the Administrative Procedures Act. As I understand this law, one of its requirements is that federal agencies establish uniform standards governing their conduct. According to Judge Leon, the FDA has violated this requirement by refusing to act in the case of thiopental for lethal injection, as opposed to all the many actions the FDA does take to ensure that only safe and effective drugs are approved for import.


Shortages of Drugs for Lethal Injection