Case Name: ISTA Pharm., Inc. v. Food and Drug Administration, C.A. No. 1:11-CV-0907, 2012 U.S. Dist. LEXIS 93836 (D.D.C. July 9, 2012) (Gwin, J.)
Drug Product and Patent(s)-in-Suit: Xibrom® and Bromday® (bromfenac ophthalmic solution); N/A
Nature of the Case and Issue(s) Presented: In March 2005, the FDA approved ISTA’s NDA for Xibrom. In October 2010, the FDA approved ISTA’s supplement to the Xibrom labeling, including a change to the dosing regimen – from twice/day to once/day – and name change – from Xibrom to Bromday. As a result of the supplement, ISTA received three years of exclusivity for its new Bromday product. On December 18, 2009, Coastal Pharmaceuticals (“Coastal) submitted an ANDA relying on Xibrom’s twice/day labeling as the reference listed drug. On March 1, 2011, ISTA submitted a Citizen’s Petition requesting that the FDA refrain from issuing approval of any ANDAs referencing Xibrom, claiming that Bromday and Xibrom are the same product, and arguing that Bromday’s once/day labeling was the “currently approved” label, thus the three-year exclusivity agreement banned such approval. In the alternative, ISTA urged the FDA to decline Coastal’s ANDA until there was a determination that Xibrom was not removed from the market for issues concerning safety and efficacy. ISTA pulled Xibrom from the market one day before it filed its Citizen’s Petition. On May 11, 2011, the FDA approved Coastal’s ANDA and denied ISTA’s Citizen’s Petition, explaining that Xibrom and Bromday were two separate drugs and that the Bromday once/day labeling was not the “currently approved” labeling for Xibrom. The FDA also determined that Xibrom was not withdrawn for safety or efficacy reasons
ISTA filed suit in the District Court for the District of Columbia, and the parties filed cross motions for summary judgment. ISTA alleges that the FDA unlawfully approved Coastal’s ANDA for two reasons: (i) Xibrom’s twice/day labeling is obsolete and not “currently approved labeling” as required by the FDCA for purposes of a generic manufacturer’s reliance on the labeling of the reference listed drug; and (ii) Coastal’s generic is unsafe. The court rejected both arguments.
Why FDA Prevailed: ISTA argued that Xibrom and Bromday are a single product, and thus, Bromday’s label is the only “currently approved” label. But the court found that ISTA failed to offer any substantial basis for its contention that Xibrom’s label was (and is) not currently approved. ISTA could have revised Xibrom’s labeling and sold Xibrom as a twice/day product. Moreover, ISTA failed to cite any authority supporting its position that Xibrom was not, and is not, a currently approved label, or that discontinued drugs cannot serve as reference label drugs. Moreover, the court held that FDA regulations explicitly anticipate ANDAs relying on drugs that the branded manufacturer no longer sells. See 21 C.F.R. § 314.122.
Next, the court found that the FDA is required to determine whether a listed drug that has been voluntarily withdrawn from sale was withdrawn for safety and efficacy reasons prior to approving an ANDA that refers to the listed drug. The court held that it did just that. ISTA voluntarily stopped selling Xibrom, and the FDA never removed Xibrom from the list of approved drugs and ISTA never indicated—until Coastal’s ANDA—that Xibrom and Bromday were one product or that Xibrom was unsafe. The court found that ISTA had always treated Xibrom and Bromday as two separate products and that “ISTA’s now-inconsistent assertion is a poorly-disguised gambit to avoid competition, game the drug-approval system, and maintain a monopoly over the bromfenac eyedrop market.”
Finally, the FDA did not conclude that Bromday was in any way unsafe, even though it denied ISTA’s request for a larger bottle size. While the FDA has admittedly asked some sponsors to voluntarilychange their labeling to address some safety concerns, it had not required any changes thus far. Therefore, until the FDA reaches a final conclusion on the safety of the fill size and requires Xibrom to change its label, any generic can reference the current label.
