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February 09, 2024

High Profile Challenges to Scope and Breadth of AKS Are Cases to Watch

Following Advisory Opinions in which the United States asserted that patient financial assistance programs could violate the Anti-Kickback Statute (AKS), 42 U.S.C. § 1320a-7b(b), two players within the pharmaceutical industry brought high profile challenges to the Opinions.  In Pfizer, Inc. v. United States Department of Health and Human Services et al, 1:20-cv-4920 (MKV) (S.D.N.Y) and Pharmaceutical Coalition for Patient Access (PCPA) v. United States et al., 3:22-cv-00714-RCY (E.D.VA), the plaintiffs each argued that the United States’ interpretation of the AKS criminalizes broad swaths of “routine, beneficial conduct” and precludes “financially-needy patients” from accessing “critical, life-extending care.”  

Pfizer’s case was ultimately unsuccessful in the Second Circuit, and the United States Supreme Court declined to take it on review in January 2023.  

PCPA was filed second and sought to take advantage of recent United States Supreme Court decisions pertaining to other criminal statutes, arguing that the cases supported its argument that the US’s interpretation is constitutionally overbroad and contrary to the rule of leniency.  

On January 17, 2023, the District Court issued a decision granting summary judgment against PCPA.  An appeal to the Fourth Circuit U.S. Court of Appeals is expected and could set up a potential circuit split.  In its opposition to Pfizer’s Petition for Certiorari, DOJ acknowledged the pending PCPA case and admitted that if a circuit split develops, review by the high court may be appropriate.  Find materials for Pfizer, Inc. v. United States Department of Health and Human Services et al, at United States Supreme Court Docket 22-339. The District Court Decision in Pharmaceutical Coalition for Patient Access v. United States et al., is available here

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