FDA Can't Make Exception to Ban on Misbranded Drug Imports for Death Penalty Drugs, Says D.C. Circuit
In a suit brought by a group of death row inmates, the U.S. Court of Appeals for the D.C. Circuit on July 23 affirmed a lower court decision that the Food and Drug Administration is violating the Food, Drug, and Cosmetic Act by allowing imports of misbranded and unapproved sodium thiopental by state correctional departments for use in lethal injections. FDA argued it had discretion to enforce import provisions of the FD&C Act as it saw fit, without being subject to judicial review. But both the D.C. District Court and the appeals court found the FD&C Act clearly requires FDA to refuse admission to misbranded and unapproved new drugs, so the matter is not up to agency discretion.
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Sodium thiopental is used as part of a three-step process to execute inmates sentenced to death by lethal injection. The executioner first injects thiopental into the prisoner to act as an anesthetic. The executioner then injects pancuronium bromide to paralyze the prisoner, and finally potassium chloride to stop the prisoner’s heart.
Thiopental was last manufactured in the U.S. in 2009. Since, state departments of correction have imported thiopental made by Dream Pharma and marketed by Archimedes Pharma, which are both companies based in the United Kingdom. Neither Dream nor Archimedes are registered with the FDA, which makes the thiopental they supply misbranded. And thiopental is not an approved drug, either. For those reasons, FDA at first detained shipments of thiopental destined to the state corrections departments. But after an explanation from the states, FDA began to allow the imports, and in 2011 the agency issued a policy statement where it said it would exercise “enforcement discretion” by not reviewing shipments of thiopental to the state authorities, and would “allow processing through [CBP’s] automated system for importation.” Several inmates sentenced to death in Arizona, California, and Tennessee brought suit.
FDA said the relevant section of the FD&C Act, 21 USC 381(a), gives FDA discretion as to whether it bars admission of a particular shipment of misbranded, adulterated, or unapproved drugs. As had the district court, the appeals court disagreed. According to the D.C. circuit, the statute clearly says that when drugs are imported from unregistered sources, FDA “shall” get samples from CBP. And if those samples show the shipments are misbranded, adulterated, or unapproved, “then such article shall be refused admission.” In this case, FDA took affirmative steps to allow admission of thiopental, including the policy statement, that directly contravened the FD&C Act.
As such, the appeals court affirmed the district court order permanently barring imports of the misbranded and unapproved thiopental into the U.S. But the appeals court vacated another district court order ordering FDA to mandate redelivery of all such thiopental still in possession of the states, because the affected states didn’t participate in the case and couldn’t represent their interests.
(Daniel Wayne Cook, et al., v. Food and Drug Administration; D.C. Circ. No. 12-5176, dated 07/23/13)