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The Clash Over Medicare: Key Lawsuits Challenging the IRA’s Drug Negotiation Provisions
While negotiations with the first 10 pharmaceutical manufacturers continue, multiple lawsuits challenging the Inflation Reduction Act (IRA) are also underway.
Plaintiffs across all lawsuits generally allege similar violations of the Medicare Drug Negotiation
Program1-9 (Table):
- Fifth Amendment—Taking Clause Claim: the program constitutes an uncompensated physical taking of personal property, violating the Fifth Amendment’s Taking Clause. Essentially, the plaintiffs believe the program seizes their property without just compensation.
- First Amendment—Compelled Speech Claim: the program compels them to endorse or communicate a message they do not agree with, violating their First Amendment rights.
- Eighth Amendment—Excessive Fines: the tax forces manufacturers to comply with the price controls dictated by the government.
- Unconstitutional Condition: the program imposes unconstitutional conditions on their participation in Medicare and Medicaid, making it difficult for them to participate in these essential federal programs without violating their rights.
- Administrative Procedures Act: the program overrides the Medicare statute’s definition of “qualifying single source drug” and “bona fide marketing.”
- Nondelegation Doctrine: Congress delegated broad authority to the US Department of Health and Human Services (HHS), encroaching on separation-of-powers and nondelegation principles by failing to provide HHS with reasonable guidelines and constraints to implement the program.
Table. Current Status of Lawsuits Against the Inflation Reduction Act.
| Plaintiff | Alleged Violation | Status |
| Bristol Myers Squibb and Janssen Pharmaceuticals (companion cases)1 | Fifth Amendment, First Amendment, Unconstitutional | Government granted summary judgment; plaintiffs appealed in May |
| AstraZeneca (AZ)2 | Administrative Procedure Act, Fifth Amendment | Government granted summary judgment; plaintiffs appealed in April. AZ must file their appellant brief by July 15 |
| PhRMA, Global Colon Cancer Association (GCCA), and National Infusion Center Association (NICA)3 | Nondelegation doctrine, Eighth Amendment, Fifth Amendment | Government granted summary judgment; NICA has been dismissed; plaintiffs appealed |
| Dayton Area Chamber of Commerce4 | First Amendment, Fifth Amendment, Nondelegation doctrine | Waiting on a decision |
| Merck5 | First Amendment, Fifth Amendment | Waiting on a decision |
| Novo Nordisk6 | First Amendment, Fifth Amendment, Nondelegation Doctrine, Administrative Procedure Act | Waiting on a decision |
| Novartis7 | First Amendment, Fifth Amendment, Excessive Fines Clause | Waiting on a decision |
| Boehringer Ingelheim (BI)8 | First Amendment, Fifth Amendment, Eighth Amendment, Administrative Procedure Act, Unconstitutional | Government granted summary judgment on July 3; unclear if plaintiffs will appeal |
| Astellas9 | First Amendment, Fifth Amendment | Voluntarily dismissed |
Stay tuned as these pivotal legal battles unfold and shape the future of the Medicare Prescription Drug Negotiation Program.
For updates on how these cases and other legislative developments may impact cancer care, join us at the upcoming Clinical Pathways Congress + Cancer Care Business Exchange in Boston, from September 6-8, 2024, to collaborate with industry leaders, health care professionals, researchers, payment reform experts, and innovators in oncology.
References
1. Bristol Myers Squibb Co v Becerra (D NJ 2024).
2. AstraZeneca Pharma LP v Becerra (D DE, D Wilmington VA 2024).
3. National Infusion Center Association v Becerra, No. 1:23-CV-707 (WD TX).
4. Dayton Area Chamber of Commerce v Becerra, No. 3:23-cv-00156 (SD OH).
5. Merck & Co v Becerra, No.1:23-c-01615 (D DC).
6. Novo Nordisk v Becerra, No. 3:23-cv-20814 (D NJ).
7. Novartis Pharmaceuticals Corp v Becerra, No. 3:23-cv-14221 (D NJ).
8. Boehringer Ingelheim Pharmaceuticals v US Department of Health and Human Services, No. 3:23-cv-01103 (D New Haven CT).
9. Astellas Pharma US Inc v US Department of Health and Human Services, No. 1:23-cv-04578 (ND Ill).
