The US Court of Appeals for the District of Columbia Circuit [official website] ruled [opinion, PDF] on Tuesday that the Food and Drug Administration (FDA) [official website] policy allowing the importation of a drug used in the execution of state prisoners was illegal. The court did not give deference to the federal agency's policy of neither approving or reviewing shipments of sodium thiopental from Dream Pharma [corporate website], a British manufacturer, because the policy was arbitrary and capricious. The court said sodium thiopental, a drug whose manufacture and purpose of use has not been regulated by the FDA, was "misbranded" and an "unapproved new drug," violating the Food, Drug, and Cosmetic Act (FDCA) and the Administration Procedure Act (APA) [texts]. The court concluded, "The FDA acted in derogation of [its] duties by permitting the importation of thiopental, a concededly misbranded and unapproved new drug, and by declaring that it would not in the future sample and examine foreign shipments of the drug despite knowing they may have been prepared in an unregistered establishment.
Thiopental is administered first in lethal injections to induce anesthesia, but, if not given in proper dosage, the drug can cause a "substantial, constitutionally unacceptable risk" of suffocation and pain. Death row prisoners from Arizona, California and Tennessee brought suit against the FDA and Department of Health and Human Services. Sodium thiopental has not been domestically manufactured in the US for over a decade. The shortage of sodium thiopental in the US has caused several states to modify lethal injection protocol, which has led to a number of constitutional challenges by death row inmates. In August 2011 an Arkansas judge ruled that the state law provision allowing "any other chemical or chemicals" to be used for lethal injections violated the protection against cruel and unusual punishment [JURIST report]. The Arkansas Department of Correction came under fire for purchasing thiopental from overseas. In March 2011 two Texas inmates requested stays on their executions [USA Today report] to obtain more information on the new protocol and possibly challenge the protocol as unconstitutional. Texas acknowledged that its supply of sodium thiopental had an expiration date of March 1. Arizona, Georgia and Oklahoma have faced similar challenges and are seeking to substitute the sodium thiopental used in the lethal injection "cocktail" with pentobarbital.