The U.S. Food and Drug Administration says a federal judge overstepped his bounds in a ruling that could force Nebraska to surrender one of its lethal-injection drugs.
In a brief filed this week with the U.S. Court of Appeals for the Washington, D.C., Circuit, the FDA appeals a March ruling by U.S. District Judge Richard Leon, who said the agency must immediately notify state correctional departments in possession of any foreign-manufactured sodium thiopental "that the use of such drug is prohibited by law and ... that thiopental must be returned immediately to the FDA.”
Nebraska and several other states in which sodium thoipental is part of the execution protocol were forced to buy it overseas when the last U.S. manufacturer quit making it in 2010 because of death-penalty opposition from overseas customers.
Leon sided with lawyers for death row inmates in Tennessee, Arizona and California who say the foreign-made sodium thiopental is an unapproved drug.
FDA lawyers point to a 1985 U.S. Supreme Court ruling in Heckler v. Chaney that said the FDA's decision to not take enforcement action in a lethal-injection drug case was not subject to judicial review. That case involved a challenge by death-row inmates in Texas and Oklahoma who argued that U.S.-manufactured lethal injection drugs in the possession of prison officials had not been certified by the FDA as "safe and effective" for human executions, and thus should be barred from being distributed via interstate commerce.
The FDA argues that Leon "expressly rejected FDA’s explanations that it does not want to expend resources on an area it considers distant from its public health mission, and that it has historically deferred to law enforcement."
"As the Supreme Court recognized in Heckler, overriding an agency’s discretion to decide whether to engage in enforcement proceedings interferes with the agency’s determinations about whether particular enforcement actions are counterproductive or unduly tax agency resources in relation to other responsibilities that the agency may regard as more pressing," the brief says.
Lawyers for the inmates have until Jan. 11 to reply with their brief.
The FDA letter to Nebraska officials is available in Adobe .pdf format.
The FDA Law Blog of Hyman, Phelps & McNamara posts, "FDA Presses “Heckler Defense” in Appeal of Unapproved Thiopental Sodium Death Row Inmate Case. It's written by Kurt R. Karst.
Earlier coverage of Judge Leon's ruling on the FDA and the importation of lethal injection drugs begins at the link.
FDA’s opening brief in the Agency’s appeal of a March 27, 2012 Memorandum Opinion and accompanying Order issued by Judge Richard J. Leon of the U.S. District Court for the District of Columbia (as modified by a June 22, 2012 Order) in Beaty v. FDA, 853 F. Supp. 2d 30 (D.D.C. 2012) (now Cook v. FDA) concerning FDA’s exercise of enforcement discretion with regard to the importation of unapproved sodium thiopental for use by state Departments of Corrections to carry out death sentences by lethal injection is all about the U.S. Supreme Court’s decision in Heckler v. Chaney, 470 U.S. 821 (1985). In Heckler, the Court rejected a challenge to FDA’s determination that the Agency would not take enforcement action in the lethal injection context, and held that FDA’s determinations about the circumstances in which the Agency would take enforcement action were not subject to judicial review, because “agency refusals to institute investigative or enforcement proceedings are committed to agency discretion.” In Beaty, the outcome was different.
As we previously reported (here and here), Judge Leon’s decision to grant summary judgment to Plaintiffs stems from a February 2011 lawsuit (amended in July 2011) brought against FDA by death row inmates alleging violations of the Administrative Procedure Act (“APA”) and the FDC Act. Specifically, the Plaintiffs alleged that FDA violated the APA (5 U.S.C. § 706(2)(A)) by improperly allowing shipments of a misbranded and unapproved new drug to enter the U.S. contrary to the FDC Act, and violated the APA (5 U.S.C. § 706(2)(A)) by departing from longstanding Agency policies and undermining the purpose of the FDC Act.At issue in the case is FDC Act § 801(a), which concerns imports.