## Facts

- Public-interest organizations sued FDA and related federal officials, challenging FDA’s long inaction on approvals for subtherapeutic uses of medically important antibiotics in livestock feed.
- FDA had issued 1977 Notices of Opportunity for Hearing proposing to withdraw approvals for certain penicillin and tetracycline feed uses after concluding the uses were “not shown to be safe” due to risks of antibiotic resistance affecting humans.
- FDA did not complete the contemplated withdrawal proceedings for decades, leaving the notices dormant without hearings or final withdrawal decisions.
- In earlier rulings in the same litigation, the court held that 21 U.S.C. § 360b(e) imposed a nondiscretionary duty to proceed with withdrawal once FDA had made “not shown to be safe” findings, and it ordered FDA to move forward.
- The 2012 decision addressed remedy and timing: FDA proposed a schedule to resume and complete the withdrawal process; plaintiffs sought a significantly accelerated, court-imposed timetable and additional injunctive measures.

## Issues

1. Whether FDA’s proposed compliance schedule for withdrawal proceedings was “unreasonably delayed” under APA § 706(1) given the history of prolonged agency inaction.
2. Whether the court should impose a faster, more detailed timetable and additional injunctive relief to ensure timely compliance with § 360b(e).

## Decision

- The court accepted FDA’s proposed schedule and declined to impose the accelerated timetable requested by plaintiffs.
- The court denied additional injunctive measures beyond enforcing that FDA proceed with the withdrawal process required by § 360b(e).
- Applying APA unreasonable-delay principles, the court held the forward-looking schedule was not so protracted or indefinite as to warrant more aggressive judicial intervention.
- The court emphasized the complexity and resource demands of withdrawal proceedings (scientific record development, notice, and potentially trial-type hearings) and cautioned against judicial management of agency priorities.

## Legal Principles

- Under 5 U.S.C. § 706(1), a court may compel agency action unlawfully withheld or unreasonably delayed, but remedies must respect limits on judicial supervision of agency resource allocation and priorities.
- Where a statute imposes a nondiscretionary duty to proceed (here, withdrawal proceedings under 21 U.S.C. § 360b(e) following “not shown to be safe” determinations), a court may compel action while still allowing the agency latitude on scheduling absent unreasonable delay.
- Unreasonable-delay analysis is guided by a “rule of reason” and considers, among other factors, the absence or presence of statutory timetables, competing agency priorities, and the practical demands of complex administrative processes.

## Conclusion

The court enforced FDA’s obligation to proceed with statutory withdrawal proceedings for certain subtherapeutic antibiotic uses in animal feed but declined to accelerate FDA’s proposed timetable, holding that the forward-looking schedule was not an unreasonable delay under the APA given the proceedings’ complexity and institutional limits on judicial control of agency calendars.


Nat. Res. Def. Council, Inc. v. Food & Drug Admin., 884 F. Supp. 2d 108 (S.D.N.Y. 2012)