471 F. App'x 1
D.C. Cir.2012Background
- FDA conducted a 2007 proceeding on a citizen petition about abbreviated new drug applications for generic acarbose, allowing in vitro studies if scientifically valid for bioequivalence.
- ViroPharma, Inc. did not manufacture acarbose and was not a party to that acarbose proceeding.
- In September 2010, ViroPharma filed suit claiming FDA's acarbose interpretation effectively amended the agency's regulations.
- The district court dismissed for lack of jurisdiction, ruling ViroPharma lacked standing; the court of appeals agreed.
- Standing requires injury in fact, causation, and redressability; ViroPharma failed to prove these elements.
- ViroPharma’s theory of injury based on FDA precedent affecting its drug Vancocin was not traceable to the acarbose decision and not redressable.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether ViroPharma has standing to challenge FDA interpretation | ViroPharma asserts injury from regulatory precedent harming Vancocin. | FDA argues no injury-in-fact, no causation, no redressability. | No standing; dismissal affirmed. |
Key Cases Cited
- Lujan v. Defenders of Wildlife, 504 U.S. 555 (U.S. 1992) (standing requires injury, causation, and redressability)
- Sea-Land Serv., Inc. v. Dep’t of Transp., 137 F.3d 640 (D.C. Cir. 1998) (mere agency precedential effect not enough for standing)
- Radiofone, Inc. v. Federal Commc’ns Comm’n, 759 F.2d 936 (D.C. Cir. 1985) (addressing standing with respect to agency actions)
- Teva Pharmaceuticals USA, Inc. v. Sebelius, 595 F.3d 1303 (D.C. Cir. 2010) (imminence exception discussed for third-party precedent)