The IRA includes provisions to lower prescription drug prices for people with Medicare by requiring manufacturers of certain drugs covered under Medicare Part D (starting in 2026) and Part B (starting in 2028) to negotiate prices with the government. That drug negotiation program would establish an upper limit for the maximum “fair” price for a given drug according to the government. That is, the program establishes price controls for certain prescription medications that will preclude manufacturers of those medications from receiving fair market value. And in June 2023, the Centers for Medicare and Medicaid Services—a component of the Department of Health and Human Services—issued guidance on the agency’s plans for implementing the program.
In this case, Bristol Myers Squibb and Jassen Pharmaceuticals, Inc.—whose drugs are two of the 10 initial drugs subject to the drug negotiation program—challenged the constitutionality of the program in the District of New Jersey. The drug manufacturers allege that the program violates: (1) the First Amendment by compelling them to agree to a drug price the government states is “fair”; (2) the Fifth Amendment’s Takings Clause by not providing just compensation for their drugs; and (3) the unconstitutional conditions doctrine—a doctrine that limits the government’s ability to condition the receipt of a benefit on the waiver of a constitutional right. Unfortunately, the district court granted judgment for the government, concluding that the program neither affects a taking nor violates the unconstitutional conditions doctrine because participation in the program is voluntary and that the program regulates conduct, not speech. The drug manufacturers then unsuccessfully appealed the district court’s decision to the 3rd Circuit.
On January 22, 2026 Bristol Myers Squibb and Janssen petitioned the U.S. Supreme Court for certiorari. The NAM filed an amicus brief supporting their petition. Our brief reemphasizes the constitutional violations imposed by the IRA, highlighting the importance of preserving a free drug market that drives innovation and promotes the manufacture of high quality pharmaceuticals that are critical to patient health.