United States District Court, District of Columbia
[Copyrighted Material Omitted]
Benjamin C. Block, Skye L. Perryman, Covington & Burling LLP, Washington, DC, for Plaintiff.
Andrew E. Clark, U.S. Department of Justice, Washington, DC, for Defendants.
OPINION & ORDER (AMENDED)
[Resolving Doc. Nos. 36; 40]
JAMES S. GWIN, District Judge.
Plaintiff ISTA Pharmaceuticals, Inc., brings this action against the Defendants, the Food and Drug Administration, the Commissioner of Food and Drugs, Margaret A. Hamburg, and the Secretary of Health and Human Services, Kathleen Sebelius (collectively, " FDA" ). Plaintiff ISTA alleges that the FDA unlawfully approved a generic version of an ISTA eye-drop drug. [Doc. 1.] Coastal Pharmaceuticals, the manufacturer and marketer of the generic eye-drops, intervened as a Defendant. [Doc. 7.] The parties filed cross motions for summary judgment. [Docs. 36; 40.] For the following reasons, the Court finds that the FDA acted lawfully, DENIES ISTA's motion for summary judgment, and GRANTS the FDA's motion for summary judgment.
1. Statutes and Regulations
The Federal Food, Drug, and Cosmetic Act (" FDCA" ) requires all pharmaceutical companies wishing to market " pioneer" or " innovator" drugs to first obtain FDA approval through a New Drug Application. (" NDA" ). The NDA must contain sufficient data to demonstrate the safety and effectiveness of the product. 21 U.S.C. § 355. In addition, the FDCA permits manufacturers that wish to produce a generic version of an approved drug product to submit an abbreviated new drug application (" ANDA" ). Id. at § 355(j). An ANDA applicant can rely on the FDA's prior finding of safety and effectiveness for a previously-approved NDA— the " reference listed drug" — as long as the ANDA is the same as, bioequivalent to, and references the currently approved labeling of an innovator drug. Id.; 21 C.F.R. § 314.94(a)(8)(i).
2. Administrative Record
In March 2005, the FDA approved ISTA's NDA for Xibrom, a bromfenac ophthalmic solution (eyedrops prescribed to reduce pain and inflamation following cataract surgery). The FDA approved Xibrom in a 2.4ml bottle size sufficient for use twice-a-day on one or both eyes. In October 2010, the FDA approved ISTA's supplement to Xibrom labeling— including a change to the dosing regimen (from twice-a-day to once-a-day) and name change (from " Xibrom" to " Bromday" )— and ISTA received three years of exclusivity for the new Bromday. ...