Ista Pharmaceuticals, Inc. v. Food and Drug Administration

Citation: Not availableDocket: Civil Action No. 2011-0907

Court: District Court, District of Columbia; July 9, 2012; Federal District Court

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ISTA Pharmaceuticals, Inc. filed a lawsuit against the Food and Drug Administration (FDA) and its officials, alleging unlawful approval of a generic version of ISTA's eye-drop drug. Coastal Pharmaceuticals intervened as a defendant in the case. Both parties submitted cross motions for summary judgment. The court, led by Judge James S. Gwin, ruled in favor of the FDA, denying ISTA's motion and granting the FDA's motion.

The legal framework is grounded in the Federal Food, Drug, and Cosmetic Act (FDCA), which mandates that pharmaceutical companies secure FDA approval for innovator drugs through a New Drug Application (NDA). Conversely, manufacturers aiming to produce generic drugs can submit an abbreviated new drug application (ANDA) that can rely on the FDA’s prior safety and effectiveness findings of a reference listed drug.

In March 2005, the FDA approved ISTA’s NDA for Xibrom, a bromfenac ophthalmic solution, and later approved a supplement in October 2010, which changed the dosing regimen and rebranded the product as Bromday, granting ISTA three years of exclusivity for the new label. Despite ISTA's marketing efforts for both Xibrom and Bromday, the FDA rejected ISTA's request for a 2.4ml bottle for Bromday, which ISTA sought to mirror Xibrom's dosage.

Coastal Pharmaceuticals submitted an ANDA in December 2009, referencing Xibrom's twice-a-day dosing. ISTA subsequently filed a Citizen’s Petition in March 2011, urging the FDA to halt any ANDA approvals for Xibrom, claiming Bromday and Xibrom were identical products and that the exclusivity agreement should prevent such approvals. The FDA approved Coastal’s ANDA and denied ISTA’s petition in May 2011, clarifying that Xibrom and Bromday were distinct drugs and that Xibrom had not been withdrawn for safety or efficacy reasons.

ISTA filed a lawsuit seeking a temporary restraining order against the approval of Coastal’s ANDA for a generic version of bromfenac, but the Court denied this motion. Subsequently, the parties agreed to consolidate the preliminary injunction motion with the main proceedings, leading ISTA to file an Amended Complaint highlighting FDA safety concerns about bromfenac solutions. Both parties submitted revised cross-motions for summary judgment regarding the FDA's approval process. ISTA contends that the FDA improperly approved Coastal's ANDA for two main reasons: first, that the twice-a-day labeling for Xibrom is obsolete and not 'currently approved'; and second, that the FDA deemed the 2.4ml bottle size unsafe, rendering Coastal's generic unsafe as well. 

The Court systematically rejects ISTA’s arguments. It clarifies that FDA decisions are reviewable under the Administrative Procedure Act (APA), which prevents arbitrary or capricious actions. For an ANDA applicant like Coastal, it is required to submit a copy of the 'currently approved labeling' of a reference drug. ISTA's claim that Xibrom's label is not currently approved is deemed misleading, as the FDA had previously approved Xibrom’s label in 2005, and Bromday—approved in 2010—shares the same formulation and indication. ISTA's assertion that both products are one and the same lacks substantial support, particularly since ISTA chose to promote Bromday as a new product rather than revising Xibrom’s labeling. The Court finds ISTA's extensive arguments unpersuasive and emphasizes that it could have updated Xibrom’s labeling instead of focusing on the new product.

ISTA withdrew Xibrom from the market just before filing a Citizen’s Petition against Coastal’s generic version. ISTA did not provide authority to support its claim that Xibrom was not a currently approved drug or that discontinued drugs cannot serve as reference labels. There is no statutory or regulatory prohibition preventing the FDA from approving Coastal’s generic version of Xibrom. The FDA removes drugs from its approved list only under specific conditions related to safety or effectiveness, per 21 C.F.R. 314.162(a). The regulations allow abbreviated new drug applications (ANDAs) to reference drugs that are no longer marketed, provided a petition is submitted to determine if the drug was withdrawn for safety or effectiveness reasons, as stated in 21 C.F.R. 314.122.

The FDA assessed that Xibrom had not been withdrawn for such reasons before approving Coastal's ANDA. Throughout the process, the FDA maintained that Xibrom remained on the approved list, while ISTA had previously treated Xibrom and Bromday as separate products until faced with competition. ISTA's inconsistent claims appear to aim at avoiding competition and maintaining a monopoly over the bromfenac market.

The court concluded that ISTA did not demonstrate that Bromday and Xibrom are the same product, affirming the FDA's determination that Xibrom's label was still approved. Consequently, the court upheld the FDA’s approval of Coastal’s ANDA and dismissed ISTA’s Citizen’s Petition, stating the FDA acted within its regulatory framework and did not act arbitrarily or capriciously.

ISTA further alleged that the FDA violated regulations by approving Coastal’s ANDA for a drug it claimed was withdrawn for safety reasons. However, the FDA’s conclusion that Xibrom was not withdrawn for safety or effectiveness was supported by the Administrative Record, despite ISTA’s claims about safety concerns surrounding Xibrom's labeling and packaging.

The Court found that the FDA fulfilled its obligations regarding the approval of Abbreviated New Drug Applications (ANDAs) and did not act unlawfully in approving Coastal’s ANDA for generic bromfenac. Unlike New Drug Applications (NDAs), which require evaluations of safety and effectiveness, ANDAs only require the FDA to determine if the generic drug is the same as the innovator drug. Xibrom was voluntarily withdrawn from the market by ISTA, and there was no indication that this withdrawal was due to safety or effectiveness issues. The FDA's determination that Xibrom was safe was supported by the Administrative Record, which also showed no inconsistency in the FDA's actions regarding requests for bottle sizes. While concerns about consumer usage and cross-contamination were noted, the FDA had not mandated label changes for Xibrom. Furthermore, the FDA denied ISTA’s request for a larger fill size for Bromday due to emerging safety concerns, but Xibrom had been approved prior to these concerns. Therefore, the FDA's approval of Coastal’s ANDA was appropriate as it referenced the currently approved Xibrom label. The Court denied ISTA’s motion for summary judgment and granted the FDA’s motion for summary judgment.