Several prison inmates convicted of capital offenses and sentenced to death by lethal injection petitioned the Food and Drug Administration (FDA) alleging that the drugs to be used for their executions were not approved for use in human executions and therefore violated the Federal Food, Drug and Cosmetic Act (FDCA). When the FDA denied enforcement, the inmates brought suit claiming violations of the FDCA and requesting that the FDA be required to take enforcement actions. The district court granted summary judgment to the FDA holding that decisions declining to initiate enforcement proceedings were not judicially reviewable. The Court of Appeals for the District of Columbia Circuit reversed, finding that the decision not to begin an enforcement action was judicially reviewable under 5 U.S.C. Section 701(a)(2) and an abuse of discretion.
Are decisions made by the FDA not to exercise enforcement authority over the use of drugs precluded from judicial review by Section 701(a)(2) of the Administrative Procedure Act, 5 U.S.C. Section 501 et seq. (APA)?
Yes, they are presumptively unreviewable. Refusals of administrative agencies to exercise enforcement authority involve a complicated balancing of factors, including agency allocation of scarce resources, which are not suitable for judicial review. Thus, they are presumptively "committed to agency discretion by law" under Section 701(a)(2). This presumption may be rebutted where the substantive statute has provided guidelines for the agency to follow in exercising its enforcement powers. In the instant case, the presumption of unreviewability was not overcome by the enforcement provisions of the FDCA. The FDCA's prohibition on "misbranding" of drugs and introduction of "new drugs," absent agency approval, does not supply relevant guidelines. Neither does the FDA's "policy statement" indicating that the agency considered itself "obligated" to take certain investigative actions nor the FDCA's provision that the Secretary need not report for prosecution minor violations of the Act supply relevant guidelines.
Decisions
Decision: 9 votes for Heckler, 0 vote(s) against Legal provision: Administrative Procedure, or Administrative Orders Review
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Full Opinion by Justice William H. Rehnquist
