## Facts

- Death-row prisoners in several states challenged FDA’s decision to allow importation of sodium thiopental, an anesthetic used in lethal injection protocols.
- After domestic production ended, state correctional departments sought thiopental from foreign sources.
- FDA permitted entry of imported thiopental despite indications it was both misbranded and an unapproved new drug under the Federal Food, Drug, and Cosmetic Act (FDCA).
- The challenged imports lacked required labeling, were produced in unregistered facilities, and did not comply with requirements tied to approved new-drug applications and manufacturing standards.
- Plaintiffs sued under the Administrative Procedure Act (APA), alleging FDA’s import-admission decisions violated the FDCA’s import provisions.

## Issues

1. Whether FDA’s decisions allowing importation of thiopental were unreviewable exercises of enforcement discretion under the APA.
2. Whether 21 U.S.C. § 381(a) imposes a nondiscretionary duty to refuse admission to imported drugs that “appear” to be misbranded or unapproved.
3. Whether the district court could order FDA to notify states that existing stocks were unlawful and require states to surrender already-imported thiopental to FDA.

## Decision

- The D.C. Circuit held FDA’s import-admission decisions were reviewable because § 381(a) supplied a meaningful, mandatory standard for agency action.
- The court held § 381(a) required FDA to refuse admission when an imported drug appears to violate the FDCA; FDA could not treat that command as optional via enforcement discretion.
- The court affirmed the injunction barring FDA from allowing future importation of thiopental that appears misbranded or unapproved.
- The court vacated the portion of the injunction requiring FDA to notify state correctional departments and to obtain surrender of thiopental already in states’ possession.

## Legal Principles

- Agency nonenforcement decisions are presumptively unreviewable, but that presumption can be overcome when Congress provides “law to apply” that constrains discretion.
- Under 21 U.S.C. § 381(a), when an imported drug appears to be adulterated, misbranded, or an unapproved new drug, the agency must refuse admission.
- The “appears” standard sets a low threshold; FDA need not make a definitive merits finding before its statutory duty to refuse admission is triggered.
- Under the APA, agency action contrary to an unambiguous statutory command is “not in accordance with law.”
- Equitable relief under the APA may compel prospective statutory compliance, but courts may not impose remedial measures untethered to the statute’s operative requirement (here, refusal of admission at the border) or that overreach into third-party conduct.

## Conclusion

The D.C. Circuit required FDA to comply with the FDCA’s mandatory import-refusal scheme for drugs that appear misbranded or unapproved, rejecting FDA’s reliance on enforcement discretion to allow thiopental imports, while limiting relief to prospective import controls rather than compelled recovery of drugs already held by states.


Cook v. Food & Drug Admin., 733 F.3d 1 (D.C. Cir. 2013)