1983—When a state carries out capital punishment by lethal injection, must the drugs used have been deemed “safe and effective” for that use by the Food and Drug Administration? Writing for the majority on a divided D.C. Circuit panel (in Chaney v. Heckler), Judge J. Skelly Wright rules that the FDA arbitrarily and capriciously refused to exercise its regulatory jurisdiction over state-sanctioned use of lethal injections.
In dissent, then-Judge Scalia argues that Wright “converts a law designed to protect consumers against drugs that are unsafe or ineffective for their represented use into a law not only permitting but mandating federal supervision of the manner of state executions.” In applying the principle that agency non-enforcement decisions are presumptively non-reviewable, Scalia lambastes as the “height of irrationality” Wright’s “major reliance on what [Wright] calls the FDA’s ‘Policy Statement’”—a statement that in fact “is not an agency rule, and is indeed not even an authoritative policy statement,” but was instead “part of the policy justification set forth in a Notice of Proposed Rulemaking, with respect to a proposal that was never adopted.”
On review (in Heckler v. Chaney), the Supreme Court unanimously reverses Wright’s holding and rules that the FDA’s decision not to institute enforcement proceedings was not judicially reviewable. Even Justice Brennan joins Justice Rehnquist’s opinion for the Court, and Justice Marshall separately concurs in the judgment.