Heckler v. Chaney

1985-03-20

Headline: Court limits judicial review of agency non-enforcement, reverses ruling that FDA must act to stop states using drugs in lethal injections, making FDA refusals to enforce presumptively unreviewable.

Holding: The Court held that an agency's decision not to pursue enforcement is presumptively not subject to judicial review under the APA, and reversed the appeals court, leaving the FDA's refusal unreviewable in this case.

Real World Impact:

Makes agency refusals to enforce presumptively immune from court review.
Leaves enforcement priorities and resource choices to agencies and Congress.
Allows FDA to decline enforcement on lethal injection drugs without court orders.

Topics: agency enforcement, judicial review, drug regulation, death penalty methods, FDA discretion

Summary

Background

Several death-row inmates asked the Food and Drug Administration to stop the interstate distribution of drugs used for lethal injection. They said using these FDA‑approved drugs for executions was an unapproved and misbranded use and asked the agency to warn users, seize supplies, and recommend prosecutions. The FDA Commissioner refused, explaining uncertainty about FDA jurisdiction and deciding not to exercise enforcement discretion in this area. The inmates sued under the Administrative Procedure Act. A federal district court sided with the FDA. The Court of Appeals reversed and ordered the agency to act, and the Supreme Court granted review.

Reasoning

The central question was whether an agency’s choice not to pursue enforcement can be reviewed by courts. The Court said such refusals are presumptively committed to agency discretion and therefore not subject to judicial review under 5 U.S.C. §701(a)(2), unless the substantive statute provides clear standards or other “law to apply.” The Court examined the Food, Drug, and Cosmetic Act and found its enforcement provisions permissive and lacking judicially manageable guidelines that would overcome the presumption. The Court therefore did not address whether the FDA had jurisdiction over the executions, and reversed the Court of Appeals, leaving the FDA’s decision not to act unreviewable.

Real world impact

The ruling means courts generally will not second‑guess agencies when they refuse specific enforcement steps unless Congress has plainly limited that discretion. It leaves enforcement priorities and resource choices with agencies and Congress. The decision does not prevent future review where statutes supply clear standards or where constitutional rights are asserted.

Dissents or concurrances

Justice Brennan agreed with the judgment but stressed recognized exceptions where review remains available. Justice Marshall concurred only in the judgment and warned that the new presumption of unreviewability may improperly limit judicial oversight of agency inaction.