Ista Pharmaceuticals, Inc. v. Food and Drug Administration
898 F. Supp. 2d 227
D.D.C.2012Background
- ISTA sued FDA and related officials after FDA approved Coastal’s generic bromfenac ANDA referencing Xibrom/Bromday labeling; Coastal Pharmaceuticals intervened in the suit.
- FDA approved ISTA’s NDA for Xibrom (bromfenac ophthalmic solution) in 2005 and later Bromday labeling in 2010 with three years of exclusivity for Bromday.
- ISTA marketed Xibrom and Bromday concurrently for a period and challenged that the Xibrom labeling was not the “currently approved” label for reference purposes.
- FDA determined Xibrom and Bromday were separate products and that Xibrom’s labeling remained “currently approved,” while Bromday’s labeling was not the baseline for exclusivity.
- ISTA argued Xibrom was withdrawn for safety or effectiveness; FDA denied ISTA’s Citizen’s Petition; ISTA sought injunctive relief, and the court consolidated and reviewed under the APA.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether FDA’s approval of Coastal’s ANDA relying on Xibrom labeling was lawful | ISTA contends Xibrom’s label was obsolete and not “currently approved” | FDA relied on approved labeling and treated Xibrom and Bromday as separate products | FDA lawful; Xibrom’s label was currently approved; Bromday distinct from Xibrom |
| Whether Xibrom was withdrawn for safety or effectiveness reasons | ISTA argues Xibrom was withdrawn for safety/efficacy concerns | ISTA voluntarily withdrew Xibrom; no safety/efficacy withdrawal by FDA | Xibrom not withdrawn for safety/efficacy concerns; FDA consistent in allowing Coastal’s ANDA |
| Whether FDA properly denied ISTA’s Citizen’s Petition about reference labeling | ISTA sought to block approval based on labeling interpretation | FDA denied petition, finding labeling appropriate and safety considerations addressed | FDA denial of the petition proper; no arbitrary or capricious action by FDA |
Key Cases Cited
- Marsh v. Ore. Natural Res. Council, 490 U.S. 360 (U.S. 1989) (court review under APA requires reasoned decision making)
- Settles v. U.S. Parole Comm’n, 429 F.3d 1098 (D.C. Cir. 2005) (summary judgment appropriate for agency challenges under APA)
- Fund for Animals v. Babbitt, 903 F. Supp. 96 (D.D.C. 1995) (summary judgment available in agency decision challenges)