## Facts

- Alcon Laboratories marketed WANS, a prescription antiemetic suppository containing pyrilamine maleate and pentobarbital sodium, for roughly 25 years.
- In 1978, the FDA raised concerns about the absence of adequate evidence of safety and efficacy and reports of serious, sometimes fatal, reactions in children associated with drugs containing the same barbiturate component.
- The FDA concluded WANS was a “new drug” requiring an approved new drug application under 21 U.S.C. § 355 and treated continued marketing as unlawful.
- The United States filed in rem seizure actions under 21 U.S.C. § 334 and seized quantities of WANS; it also filed in personam actions seeking temporary and permanent injunctive relief to halt manufacture and distribution.
- The district court denied a temporary restraining order, consolidated the seizure and injunction actions, and later consolidated a second seizure action.
- The district court entered an order that (1) barred the FDA from initiating further enforcement actions against WANS in any forum, (2) dissolved or neutralized the effect of prior seizures and effectively ordered release of the drugs, and (3) remanded the matter to the FDA for further administrative proceedings to determine WANS’s “new drug” status.

## Issues

1. Whether a district court may enjoin the FDA from pursuing further FDCA enforcement (including seizures) unless the agency first conducts additional formal administrative proceedings on a drug’s “new drug” status.
2. Whether a district court may dissolve existing FDCA seizures and order release of seized drugs without adjudicating whether the drugs violate the FDCA.

## Decision

- The First Circuit reversed the district court’s order and remanded.
- The district court lacked authority to prospectively restrain the FDA from using FDCA enforcement remedies without first deciding the merits of the government’s statutory claims.
- The district court erred by dissolving the seizures and ordering release of WANS without a judicial determination whether WANS violated the FDCA.

## Legal Principles

- FDCA seizure and injunction mechanisms reflect Congress’s allocation of primary public-health enforcement responsibility to the FDA, with merits adjudication occurring in court after enforcement is initiated.
- The FDCA does not require the FDA to conduct a pre-enforcement, trial-type administrative hearing (or other extra-statutory “formal determination”) as a prerequisite to seizure or injunctive actions.
- In a seizure action under 21 U.S.C. § 334, once the court has jurisdiction over seized articles, the court must decide the merits (e.g., whether the product is a “new drug” marketed without approval) before ordering condemnation or release.
- A district court may not use equitable relief to halt future FDA enforcement across fora or to unwind seizures as a substitute for resolving the statutory merits in the consolidated enforcement cases.

## Conclusion

The First Circuit held that the district court could not block further FDA enforcement or release seized WANS without first adjudicating whether the product violated the FDCA; the statutory enforcement scheme permits prompt enforcement without pre-enforcement administrative hearings, with merits decided in the judicial proceedings.


United States v. Alcon Lab'ys, 636 F.2d 876 (1st Cir. 1981)