Novartis sues Maryland over law prohibiting restrictions on 340B drugs

Drugmaker Novartis filed a lawsuit May 29 against the state of Maryland over a new law that forbids manufacturers from "taking certain direct or indirect actions to limit or restrict the acquisition or delivery of a 340B drug."

The 340B drug pricing program has been in place since 1992 to allow qualifying hospitals and clinics that treat low-income and uninsured patients to purchase some drugs at a discounted rate between 25% and 50%.

In its complaint, Novartis alleges the Maryland law — which is slated to take effect July 1 — conflicts with the purpose of the federal 340B drug pricing program, rendering it "unconstitutional."  

"Once the law becomes effective on July 1, 2024, Novartis will risk violating Maryland law merely by continuing to implement a contract pharmacy policy that has already been

expressly declared lawful by other federal courts applying the federal 340B law," the filed complaint reads. "If H.B. 1056 is not enjoined, Novartis will continue to suffer severe irreparable harm and loss of its constitutional rights on an ongoing basis. Novartis therefore requests a preliminary injunction enjoining enforcement of H.B. 1056 pending a decision on the merits." 

The Maryland Attorney General's Office said it has no comment on the matter.

Several manufacturers, 25 to be exact, now impose some type of 340B restrictions. According to 340B Health, the comprehensive list of drugmakers that now impose some type of restrictions for 340B participants includes: AbbVie, Amgen, Astellas, AstraZeneca, Bausch Health, Bayer, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, EMD Serono, Exelixis, Gilead, GlaxoSmithKline, Jazz Pharmaceuticals, Johnson & Johnson, Merck, Novartis, Novo Nordisk, Organon, Pfizer, Sanofi, Teva, UCB and United Therapeutics.

A recent, similar case in the U.S. Court of Appeals for the Washington, D.C. Circuit sided with drug manufacturers.

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