USA— The arena of pharmaceutical pricing is witnessing a growing legal skirmish as Boehringer Ingelheim becomes the latest major drugmaker to contest Medicare’s newfound authority to negotiate prices for select top-selling medications.

In a 62-page lawsuit filed on Friday in federal district court, Boehringer Ingelheim asserts its stance against the program, echoing the sentiments of several other pharmaceutical giants who have taken legal action against what they perceive as unconstitutional measures.

Joining the ranks of companies like Merck & Co., Bristol Myers Squibb, Astellas Pharma, and Johnson & Johnson, Boehringer Ingelheim alleges that Medicare’s pricing program infringes upon the U.S. Constitution, forcing drug manufacturers to accept terms dictated by the government.

This move has sparked a series of lawsuits and drawn the attention of influential industry bodies like PhRMA and the Chamber of Commerce.

Boehringer’s lawsuit highlights the program’s essence, contending that it doesn’t foster genuine negotiations between drug manufacturers and the government regarding Medicare’s payment rates for prescription drugs.

Instead, the program compels manufacturers, under the threat of severe penalties, to provide access to their drugs at rates mandated by Medicare.

The Inflation Reduction Act of the previous year set the stage for this program, empowering Medicare to select a set of top-selling, single-source drugs for negotiation over their “maximum fair price.”

This initiative, scheduled to take effect in 2026 for the top 10 drugs with the highest spending through Medicare Part D, holds the potential to reshape the pharmaceutical pricing landscape.

Failure to align with the newly determined price could result in substantial fines or the withdrawal from Medicare participation, presenting a significant dilemma for drugmakers.

Boehringer’s legal challenge pivots on the premise that the program’s framework infringes upon the Fifth Amendment’s right to due process and protection against uncompensated property confiscation.

The lawsuit also invokes the First Amendment’s safeguard of free speech and questions the compatibility of the program with the Eighth Amendment’s prohibition of excessive fines.

The latter argument, while raised by industry bodies PhRMA and the Chamber, was not put forth by other drugmakers.

The legal battle takes center stage just ahead of a pivotal deadline set for September 1, by which Medicare is expected to unveil the first 10 drugs subject to price negotiation.

Boehringer’s complaint strongly suggests that it anticipates its diabetes drug Jardiance, developed in partnership with Eli Lilly, to be among the selected drugs.

The company cites an earlier analysis in the Journal of Managed Care and Specialty Pharmacy as the basis for its expectations.

As Boehringer Ingelheim takes on the U.S. Department of Health and Human Services, the Centers for Medicare and Medicaid Services, and their respective leaderships, the industry watches closely to observe the implications of this legal showdown.

With legal claims resting on constitutional grounds, the outcome of these lawsuits could potentially reshape the course of pharmaceutical pricing dynamics.

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