Hill Dermaceuticals, Inc. v. U.S. Food and Drug Administration
826 F. Supp. 2d 252
D.D.C.2011Background
- Hill Dermaceuticals sues FDA/HHS, seeking to enjoin approval of Identi ANDAs for Hill’s Derma-Smoothe products.
- FDA approved three Identi ANDAs for fluocinolone acetonide topical oils on Oct 17, 2011; Amneal intervened.
- Hill contends approvals violate FDCA labeling sameness, safety testing, and bioequivalence requirements.
- Hill’s citizen petition (2004) urged testing and 0.5 ppm peanut protein limit; FDA denied automatic rejection and allowed labeling differences.
- Court denies Hill’s preliminary injunction; complete record pending on the biowaiver issue while other claims fail on merits.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Labeling compliance with labeling-sameness rule | Hill argues FDA-approved labeling differs and violates 21 U.S.C. §355(j)(2)(A)(v). | FDA relies on 21 C.F.R. §314.94(a)(8)(iv) exception for differences when manufacturers differ; labeling updated per guidance. | Not likely; exception applies and Hill lacks likelihood of success. |
| Arbitrary and capricious testing requirements | Hill asserts FDA treated Hill differently by requiring testing not imposed on generics. | FDA explained no validated test exists for residual peanut protein; generics share risk profile. | Not likely; FDA’s reasoning not arbitrary or capricious. |
| Bioequivalence/biowaiver for gels/solutions | Hill contends Derma-Smoothe is not a solution, so biowaiver was improper. | Biowaiver requires product to be a solution; agency record supports waiver. | Record incomplete; court cannot determine merit at this stage. |
Key Cases Cited
- Winter v. NRDC, 555 U.S. 7 (U.S. 2008) (preliminary injunction standard; likelihood of success factors)
- PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (Sup. Ct. 2011) ( Hatch-Waxman context; generic labeling and safety expectations)
- Mylan Pharms., Inc. v. Shalala, 81 F. Supp. 2d 30 (D.D.C. 2000) (irreparable harm and injunction standards in FDA actions)
- Serono Labs., Inc. v. Shalala, 158 F.3d 1313 (D.C. Cir. 1998) (public interest and generic drug availability considerations)
- Am. Bankers Ass’n v. Nat’l Credit Union Admin., 38 F. Supp. 2d 114 (D.D.C. 1999) (equitable relief standards in administrative decisions)