The court rejected the FDA's claim that the agency's authority to admit or reject foreign drug shipments is not subject to judicial review.
The case began in October 2010 before death row inmate Jeffrey Landrigan was scheduled to be executed and Arizona did not have any sodium thiopental, a quick-action barbiturate used as one of the drugs in a three-drug lethal injection process.
FDA Changes Policy
At the time, the FDA ruled that there was no legal way to import the drug, but the Arizona Department of Corrections came up with a supply and Landrigan was executed as scheduled. Arizona denied that it used illegal means to obtain the drug.
Two months later, the FDA decided to exercise its enforcement discretion and not enforce the laws prohibiting the importation of the drug. Records showed that the FDA not only was aware of the importation of the drug, the agency facilitated the import.
By June 2011, the Drug Enforcement Administration informed Arizona it could no longer use thiopental, one day before the scheduled execution of Donald Beaty. Instead, he state used the drug pentobarbital to execute Beaty.
A Moot Question?
The Court of Appeals ruled Tuesday that the FDA failed it is responsibilties under the Food, Drug and Cosmetic Act.
"The FDA acted in derogation of those 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," the court said.
In reality, the court's ruling might seem moot. The three Arizona inmates who brought the original lawsuit have all since been executed, European countries have banned the export of thiopental for use in executions, and pentobarbital is now used instead.
But, the FDA might appeal the court's ruling to the Supreme Court to establish a legal precedent that the agency alone has the authority of imported drugs.