Hill Dermaceuticals, Inc. v. Food & Drug Administration
404 U.S. App. D.C. 214
| D.C. Cir. | 2013Background
- Hill Dermaceuticals filed NDA for Derma-Smoothe corticosteroid in 1988 (three formulations).
- In 2011 the FDA approved three Identi ANDAs for generic versions of Hill’s products.
- Hill alleged FDA approvals were arbitrary and capricious under the APA; district court granted summary judgment for FDA.
- FDA waived bioequivalence data under 21 C.F.R. § 320.22(b)(3) for body/scalp oil and § 320.24(b)(6) for ear drops.
- Appellate review focused on whether waivers were proper and whether labeling differences violated the same-labeling requirement.
- Court affirms district court’s grant of summary judgment for FDA; agency actions not arbitrary or capricious.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Extra-record evidence properly considered? | Hill argues district court should have reviewed extra-record declarations. | Agency record sufficiency dictates review; extra-records not allowed. | Not error; no substantial question of procedural validity. |
| Propriety of bioequivalence waivers? | Waivers were improper; products not true solutions under 320.22(b)(3). | Waivers appropriate; evidence shows solutions and no material differences. | Waivers upheld; FDA reasonable. |
| Scalp/oil labeling disparity's effect on waiver? | Different testing for scalp labeling undermines fairness. | Waiver rationale governs; scalp testing differences not dispositive. | Waiver supported; labeling differences not fatal. |
| Labeling requirement under same-labeling provision? | Identi’s labeling differs from Hill’s; not “the labeling approved for the listed drug.” | Hill’s method not validated; USP-NF refinement suffices; exception allows labeling changes. | Not arbitrary; FDA labeling approach permissible. |
Key Cases Cited
- Walter O. Boswell Mem’l Hosp. v. Heckler, 749 F.2d 788 (D.C. Cir. 1984) (courtistates exact record to review must mirror agency’s record)
- Es ch v. Yeutter, 876 F.2d 976 (D.C. Cir. 1989) (extra-record evidence limited to serious procedural questions)
- Theodore Roosevelt Conservation P’ship v. Salazar, 616 F.3d 497 (D.C. Cir. 2010) (limits on using extra-record evidence; defers to agency findings)
- Bennett v. Donovan, 703 F.3d 582 (D.C. Cir. 2013) (APA review remand preferred where legal error identified)