By Susan J. Matthees –
Six inmates on death row in three different states sued FDA in the U.S. District Court for the District of Columbia over the importation of thiopental sodium, one of the drugs used by some states to administer a lethal injection. The plaintiffs are asking for a declaratory judgment that imported thiopental is a misbranded, adulterated, and unapproved new drug and cannot be lawfully imported into the country, and that FDA’s recent actions allowing importation of foreign thiopental are contrary to law, arbitrary, capricious, and/or an abuse of discretion under the Administrative Procedure Act (“APA”). The plaintiffs also seek a permanent injunction prohibiting FDA from releasing any future shipments of imported thiopental and an order compelling FDA to recover and remove from interstate commerce all shipments of foreign thiopental that have been released into interstate commerce in the last 12 months.
Thiopental, which was developed in the 1930s to induce general anesthesia, was manufactured in the U.S. until 2009. Because thiopental is not available in the U.S., states using it for administration of the death penalty have been importing the drug from Europe and FDA has allowed that importation. The complaint states that FDA must deny admission to imported thiopental because it is a misbranded, adulterated, and unapproved new drug. The plaintiffs allege that imported thiopental is misbranded because it fails to include adequate warnings and other required information on the label, and because it was manufactured in a facility that has not registered with the FDA. The plaintiffs allege that imported thiopental is adulterated because it is not manufactured in accordance with FDA’s GMP regulations and it does not conform to the standard formulation established by the official United States Pharmacopeia.
The complaint also alleges that FDA’s actions with regard to permitting the importation of thiopental are inconsistent with FDA’s regulations, procedures, and established practice. As an example, the plaintiffs point to recent cases where states attempted to import foreign drugs from Canada and FDA intervened to prevent such importation. The plaintiffs also cite several cases that upheld FDA’s decisions not to allow drugs to be imported by states.
However, FDA has long taken the position that it will exercise enforcement discretion and defer to law enforcement on matters involving pharmaceuticals for lethal injection. In 1985, the U.S. Supreme Court held in Heckler v. Chaney, 470 U.S. 821 (1985), that FDA does have discretion not to investigate or commence proceedings for violation of FDC Act § 331 (which prohibits introduction into commerce an adulterated or misbranded drug). Plaintiffs distinguish Heckler from their case on the basis that Heckler does not address FDA’s obligations under FDA Act § 801, which directs FDA to refuse admission of a drug into the U.S. that appears to be adulterated or misbranded. The plaintiffs also state that Heckler addressed the unapproved use of approved drugs, whereas their case is about the importation of an unapproved, adulterated, and misbranded drug. Further, the complaint argues that FDA does not have discretion to allow unapproved new drugs to be shipped or sold in the U.S. and that FDA cannot permit the marketing of an unapproved new drug.