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.
"As in the domestic context, FDA employs a risk-based approach at the border, at times involving the exercise of enforcement discretion ... to preserve its limited resources for violations that pose the most serious threats to public health," the FDA said. "FDA may take action if drugs offered for import do not conform with various requirements, such as by being misbranded or adulterated, or by lacking required approval."
Leon's ruling also said the FDA is prohibited from allowing foreign-made sodium thiopental into the United States.
Lawyers for the inmates have until Jan. 11 to reply with their brief.
Nebraska's three-drug protocol was set by the state Department of Correctional Services after lawmakers switched to lethal injection from the electric chair in 2009. It calls for a dose of sodium thiopental to render the inmate unconscious, followed by pancuronium bromide to paralyze and potassium chloride to stop the heart.
Sodium thiopental has become increasingly difficult to obtain. The European Union recently banned the export of some barbituric acids, including sodium thiopental, further diminishing the drug's availability for use in lethal injections.
The Swiss firm Naari AG, which made the batches of sodium thiopental held by Nebraska, has said it no longer will ship the drug if it is to be used in executions. Most of the remaining manufacturers of sodium thiopental are in India and China -- and American defense lawyers have questioned the quality of the drugs they make.
The problems with obtaining sodium thiopental have prompted several states to switch to one drug -- the barbiturate pentobarbital -- for their executions.
Omaha Sen. Scott Lautenbaugh, a member of the Legislature's Judiciary Committee, has said he thinks lawmakers need to step in and possibly change Nebraska's protocol.