## Facts

- Levonorgestrel-based emergency contraceptives (including Plan B and Plan B One-Step) were initially approved as prescription-only drugs.
- Advocacy groups filed a Citizen Petition requesting over-the-counter (OTC) availability without age restrictions; the manufacturer later pursued OTC approval as well.
- In 2006, the FDA approved limited nonprescription access through a behind-the-counter regime requiring government-issued identification and imposing age cutoffs; younger users still needed prescriptions.
- FDA staff and advisory bodies generally supported broader nonprescription access based on safety and users’ ability to follow labeling.
- In December 2011, the FDA determined Plan B One-Step could be sold OTC without age restrictions, but the Secretary of Health and Human Services directed that this scientific determination not take effect.
- Shortly thereafter, the FDA denied the Citizen Petition seeking unrestricted OTC access, while maintaining age and point-of-sale restrictions.
- Plaintiffs reopened earlier litigation challenging the regulatory restrictions and the Citizen Petition denial under the Administrative Procedure Act (APA).

## Issues

1. Whether the FDA’s denial of the Citizen Petition and continuation of age and point-of-sale restrictions were arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law under the APA.
2. Whether the Secretary’s intervention overriding the FDA’s scientific judgment tainted the agency’s action and rendered the decision unlawful under the APA’s requirement of reasoned decisionmaking.

## Decision

- The court held the FDA’s denial of the Citizen Petition and related age/point-of-sale restrictions were arbitrary and capricious under the APA.
- The court found the challenged actions reflected improper political interference and departures from ordinary agency procedures.
- The court ordered the defendants to grant the Citizen Petition and make levonorgestrel-based emergency contraceptives available OTC without age or point-of-sale restrictions.

## Legal Principles

- Under the APA, agency action must reflect reasoned decisionmaking grounded in the administrative record; unexplained departures from evidence and established procedures are arbitrary and capricious.
- An agency may not maintain uniquely burdensome access restrictions for a drug when the asserted justifications conflict with the agency’s scientific findings and expert record.
- Political direction that displaces an agency’s scientific determination, and results in pretextual or non-independent reasoning, can render the resulting agency action arbitrary and capricious.
- Courts may grant mandatory relief requiring an agency to grant a petition and remove unlawful restrictions when the record shows prolonged, unjustified delay and irrational limitations on access.

## Conclusion

The court concluded that federal officials acted unlawfully under the APA by denying a petition for unrestricted OTC access to levonorgestrel-based emergency contraception and by maintaining age and point-of-sale limits inconsistent with the scientific record, and it ordered OTC availability without those restrictions.


Tummino v. Hamburg, 2013 WL 1348656 (E.D.N.Y. 2013)