Tummino v. Hamburg, 936 F. Supp. 2d 162

Plan B and Plan B One-Step are levonorgestrel-based emergency contraceptives; Plan B OTC status expanded over time but behind-the-counter restrictions remained; Secretary Sebelius ordered FDA to deny Plan B One-Step SNDA and rejected wide OTC access for all ages; FDA remanded and considered, but Secretary’s directives influenced outcomes; court previously vacated FDA denial and ordered OTC access for 17-year-olds; this opinion reverses FDA denial of the Citizen Petition and remands with instruction to grant OTC access without prescription or point-of-sale restrictions within 30 days; court discusses FDA policy deviations, extrapolation, and record considerations to assess arbitrary, capricious agency actions; decision emphasizes balancing scientific data with policy and constitutional access concerns.

Issue	Plaintiff's Argument	Defendant's Argument	Held
Whether the Secretary’s override of FDA policy was lawful	Tummino argues secretary’s intervention breached FDA policy and statutory structure	Sebelius’s order respected executive oversight and promoted public health	Yes, Secretary acted unlawfully; order arbitrary and capricious
Whether the Citizen Petition denial was arbitrary and unreasonable	FDA denial rested on shifting data standards not in petition	FDA followed data requirements and policy deviations were justifiable	No; denial reversed as arbitrary and unsupported by record
Whether FDA could extrapolate adult data to pediatric use for OTC switch	Extrapolation has precedent and was used for Plan B One-Step	Extrapolation not adequately supported for all ages; data gaps exist	Extrapolation supported for younger adolescents; motion denied as to the exclusion on this basis
Whether the behind-the-counter and age-based restrictions are permissible	Restrictions impede access to contraception in violation of law	FDA may place appropriate restrictions to ensure safe use	Restrictions not permissible; remand to remove OTC restrictions
Whether the court should remand to rulemaking rather than grant OT C switch	Rulemaking unnecessary; grant OTC without age restrictions	Rulemaking not required; FDA could act administratively	Remand granted to grant Citizen Petition and remove restrictions; not require rulemaking

INS v. Yang, 519 U.S. 26 (U.S. 1996) (arbitrary, capricious departures from policy require review)
Am. Pharm. Ass’n v. Mathews, 530 F.2d 1054 (D.C. Cir. 1976) (FDA cannot restrict distribution of safe OTC drugs to certain outlets)
Greyhound Corp. v. Interstate Commerce Comm’n, 668 F.2d 1354 (D.C. Cir. 1981) (arbitrary agency action review standards apply when remand follows prior order)
Chenery Corp. v. S. F., 332 U.S. 194 (U.S. 1947) (agency must justify grounds for change; cannot rely on post hoc reasoning)
Carey v. Population Servs. Int’l, 431 U.S. 678 (U.S. 1977) (constitutional right to access contraception; limits on age-based sales restrictions)