ViroPharma, Inc. v. Hamburg
2011 U.S. Dist. LEXIS 41027
D.D.C.2011Background
- ViroPharma sues FDA and HHS under the APA challenging FDA's interpretation of bioequivalence regulations.
- Plaintiff alleges the 2008 acarbose petition response amended regulations without notice-and-comment rulemaking.
- FDA contends no default in vivo requirement exists and relies on 21 C.F.R. § 320.24 for discretion in testing type.
- The suit concerns bioequivalence methodologies for ANDAs, including acarbose and vancomycin.
- Court reviews Rule 12(b)(1) and 12(b)(6) challenges for standing and ripeness; ultimately grants dismissal for lack of standing.
- Key regulatory framework: NDA/ANDAs, RLD, and the statutory framework for bioequivalence under 21 U.S.C. § 355.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Does ViroPharma have standing to sue under the APA? | ViroPharma suffered or will suffer injury in fact from regulatory changes. | Injuries are speculative and not causally linked to the 2008 acarbose response. | No standing; injuries not sufficiently concrete or causally linked. |
| Is the acarbose petition response an unlawful amendment requiring notice-and-comment rulemaking? | Response effectively amended regulations without notice and comment. | Response interprets existing regulations and falls within agency discretion, not a rulemaking. | Not reached; court disposed on standing grounds; court assumed as a matter of law that it might not have jurisdiction. |
Key Cases Cited
- Lujan v. Defenders of Wildlife, 504 U.S. 555 (1992) (standing requires injury, causation, and redressability)
- Pfizer Inc. v. Shalala, 182 F.3d 975 (D.C. Cir. 1999) (standing and agency action; injury must be concrete and not speculative)
- Ctr. for Law & Educ. v. Dep't of Educ., 396 F.3d 1152 (D.C. Cir. 2005) (procedural-rights standing requires substantial probability of injury)
- Fla. Audubon Soc'y v. Bentsen, 94 F.3d 658 (D.C. Cir. 1996) (standing relaxed for procedural-injury contexts but requires injury and causation)
- Teva Pharms., USA, Inc. v. U.S. Food & Drug Admin., 182 F.3d 1003 (D.C. Cir. 1999) (consideration of outside pleadings in subject-matter jurisdiction)