Caseflicks

Supreme Court of the United States • 1985

Heckler v. Chaney

470 U.S. 821 | 105 S. Ct. 1649 | 84 L. Ed. 2d 714 | 1985 U.S. LEXIS 78 | 53 U.S.L.W. 4385

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Takeaway

In short, this case establishes that an agency’s refusal to investigate or enforce is presumptively unreviewable under the APA unless Congress has meaningfully limited the agency’s enforcement discretion.

Background

Several death-row inmates challenged States’ planned use of lethal injections. They asked the Food and Drug Administration to investigate and enforce the Federal Food, Drug, and Cosmetic Act (FDCA), arguing that drugs approved for medical uses had not been approved, labeled, or tested for use in executions. They sought warnings, communications to manufacturers and prison officials, seizures of the drugs, and recommendations for criminal prosecution.

The FDA Commissioner declined. He questioned whether the FDA had jurisdiction over this use of approved drugs and stated that, even if it did, the agency would exercise its enforcement discretion not to interfere with state lethal-injection laws. The District Court granted summary judgment for the Government, treating the FDA’s refusal to enforce as essentially unreviewable.

A divided D.C. Circuit reversed. It held that the FDA had jurisdiction, that its nonenforcement decision was reviewable under the Administrative Procedure Act (APA), and that the refusal was arbitrary and capricious. It remanded with directions requiring the FDA to fulfill its statutory function. The Supreme Court reversed.

Issues

Issue #1

Whether an agency’s decision not to initiate investigative or enforcement proceedings is judicially reviewable under APA § 701(a)(2).

Holding

Generally no. An agency decision not to enforce is presumptively committed to agency discretion by law and therefore unreviewable under APA § 701(a)(2), unless Congress has supplied meaningful standards limiting that discretion.

Reasoning

The APA ordinarily permits review of final agency action, including a failure to act, but § 701(a)(2) excludes action “committed to agency discretion by law.” Under Citizens to Preserve Overton Park, this exception applies where a statute supplies no meaningful legal standard by which a court can judge the agency’s exercise of discretion.

The Court distinguished affirmative agency action from agency nonenforcement. In Overton Park, the agency had affirmatively approved a highway project under a statute containing concrete criteria. By contrast, a decision not to enforce ordinarily presents no comparable statutory benchmark for deciding which possible violations the agency must pursue.

Nonenforcement choices require agencies to balance matters particularly within their competence: whether a violation occurred, the likelihood of success, the agency’s overall enforcement policies, competing priorities, and limited resources. Agencies cannot pursue every technical violation, and courts are poorly positioned to reorder an agency’s enforcement priorities.

A refusal to enforce also resembles a prosecutor’s decision not to bring a case, an area traditionally entrusted to the Executive. Moreover, nonenforcement usually does not itself impose coercive burdens on a person’s liberty or property, while an actual enforcement action can later be reviewed for compliance with statutory limits.

The presumption is rebuttable. Congress may restrict enforcement discretion by establishing substantive priorities, mandatory duties, or otherwise meaningful standards. Dunlop v. Bachowski illustrated that point: the statute required the Secretary of Labor to investigate a union member’s complaint and to file suit upon specified findings, leaving a court standards against which to review the refusal.

Issue #2

Whether the FDCA supplies meaningful standards that overcome the presumption against review of the FDA’s refusal to take the requested enforcement action.

Holding

No. The FDCA’s enforcement provisions leave the FDA broad discretion over whether and when to investigate or bring enforcement proceedings, so the agency’s refusal was not reviewable.

Reasoning

The FDCA’s enforcement provisions are permissive rather than mandatory. The Secretary is “authorized” to conduct examinations and investigations; injunction and seizure provisions do not state when action must be brought; and criminal prosecution ultimately depends on the Attorney General. Unlike the statute in Dunlop, the FDCA does not direct the FDA to act when defined conditions exist.

The Act’s substantive prohibitions on misbranding and unapproved new drugs do not themselves constrain the FDA’s choice whether to enforce. Rules defining prohibited conduct are distinct from standards directing when the agency must investigate, seize products, seek injunctions, or recommend prosecution.

The FDA policy statement relied upon by the Court of Appeals did not provide enforceable limits on the Commissioner’s enforcement discretion. Its language was vague, arose in a different context concerning physicians’ unapproved uses of drugs, and was attached to a rule never adopted. It also could not override the FDA’s express regulation asserting discretion over decisions whether to recommend civil or criminal enforcement.

Section 336, which says the Secretary need not seek prosecution or other proceedings for minor violations when a written notice adequately serves the public interest, did not imply a duty to prosecute every major violation. That provision concerns already-established violations and does not prescribe criteria for investigating suspected violations or initiating enforcement proceedings.

Because the FDCA did not provide law to apply to this individual nonenforcement decision, the APA barred judicial review. The Court therefore did not decide the separate and difficult question whether the FDA had jurisdiction over drugs used in executions, and it did not reach the merits of the inmates’ FDCA allegations.

Concurrences

Justice Brennan

Reasoning

Justice Brennan joined the Court’s opinion on the understanding that it creates only a limited presumption for ordinary, individual nonenforcement decisions. In the usual case, Congress may reasonably be presumed to leave such routine choices to an agency’s broad discretion because courts often lack workable standards for review.

He emphasized that the presumption does not license agencies to disregard legal commands. Review may remain available where an agency wrongly disclaims jurisdiction, adopts a general policy amounting to abdication of statutory duties, refuses to enforce a valid regulation still in force, or violates constitutional rights.

Justice Brennan also noted that a decision resting on plainly illegitimate grounds, such as a bribe, should not be insulated from review. On this limited understanding, and without endorsing lethal injection or capital punishment, he concurred.

Justice Marshall

Reasoning

Justice Marshall agreed that the FDA properly declined the inmates’ request, but he rejected the majority’s new presumption that enforcement decisions are unreviewable. In his view, APA review should remain available absent clear and convincing evidence that Congress intended to preclude it, with courts applying substantial deference to legitimate agency resource-allocation decisions.

On the merits, the FDA’s stated reasons were adequate. The FDCA did not require the agency to prosecute every violation, the inmates offered no evidence that the FDA’s stated rationale was pretextual, and the agency reasonably concluded that other public-health and enforcement concerns deserved priority over intervention in a state-controlled execution system affecting roughly 200 people.

Justice Marshall argued that deferential merits review is not the same as total nonreviewability. An agency’s refusal to act could reflect vindictiveness, corruption, retaliation, a conflict of interest, or an irrational departure from settled policy. Courts should be able to review agency inaction to ensure that it does not rest on reasons Congress could not have intended the agency to consider.

He also questioned the majority’s reliance on analogies to criminal prosecutorial discretion. Administrative nonenforcement can expose specific statutory beneficiaries to ongoing concrete harms, unlike a private request to punish past criminal conduct. In his view, the APA was designed to check arbitrary administrative discretion, not to make agencies immune from judicial scrutiny whenever they decline enforcement.