OPINION AND ORDER GRANTING DEFENDANT’S MOTION TO DISMISS AND FOR SUMMARY JUDGMENT AND DENYING PLAINTIFF’S MOTION FOR SUMMARY JUDGMENT In this case, Plaintiff Pfizer Inc. seeks declarations that one or both of two potential copay assistance programs, if implemented, would not violate the federal Anti-Kickback Statute (“AKS”), and Beneficiary Inducement Statute (“BIS”). Before this case was filed, the federal government, acting through the Office of the Inspector General (“OIG”) of the Department of Health and Human Services (“HHS”), reviewed the programs and notified Pfizer that at least one of the of them could violate the statutes if implemented as Pfizer intended. The consequences of a violation could be dire for Pfizer, potentially including civil or criminal monetary penalties and exclusion of all Pfizer products from eligibility for coverage under Medicare and Medicaid. See 42 U.S.C. §§1320a-7, 1320a-7a, 1320a-7b. Before the Court are cross-motions from the parties, both seeking judgment in their favor.1 Following careful review of the parties’ submissions and having heard oral argument on the motions, Defendants’ motion is GRANTED, and Plaintiff’s motion is DENIED. FACTUAL BACKGROUND AND PROCEDURAL HISTORY A. Pfizer’s Drug and Proposed Programs The Parties substantially agree on the facts relevant to this dispute. In light of that, the Court cites to the Complaint [ECF No. 1] (‘Cpl.”). For facts not contained in the complaint, the Court cites the administrative record of proceedings before the Department of Health and Human Services [ECF No. 46] (“AR”). Pfizer produces and markets a drug called tafamidis2 to treat Transthyretin Amyloid Cardiomyopathy (“ATTR-CM”). Cpl. 1. ATTR-CM is a rare, progressive condition that causes deposits of amyloid protein to be deposited in the heart muscle. Cpl. 25. As a result, the afflicted person may experience progressive heart failure, culminating in being unable to perform even basic life tasks. Cpl. 25. Patients with diagnosed ATTR-CM have a life expectancy of 2-3.5 years after diagnosis. Cpl. 25. There are estimated to be approximately 100,000-150,000 people afflicted with ATTR-CM in the United States, with higher concentrations among the elderly and among African American males. Cpl. 3, 27. Tafamidis is currently the only FDA-approved drug to treat ATTR-CM. Cpl.
42-43. The drug was developed through extensive testing and trials over the course of nearly 20 years and benefitted from “orphan drug” classification from the FDA.3 Cpl.
