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The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading innovative biopharmaceutical research companies, which are laser focused on developing innovative medicines that transform lives and create a healthier world. Together, we are fighting for solutions to ensure patients can access and afford medicines that prevent, treat and cure disease. Over the last decade, PhRMA member companies have invested more than $850 billion in the search for new treatments and cures, and they support nearly five million jobs in the United States.
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WASHINGTON, D.C. (October 7, 2026) — Today, the Pharmaceutical Research and Manufacturers of America (PhRMA) filed a complaint in the United States District Court for the District of Columbia asserting that the Center for Medicare & Medicaid Services’ (CMS) Most Favored Nation (MFN) policy in Medicare Part B is unlawful and exceeds CMS’ statutory authority.
The final rule, known as GLOBE, imposes MFN drug price controls in Medicare Part B. Under the rule, drug manufacturers would be required to pay “rebates” to CMS that effectively limit Medicare drug prices to MFN benchmarks based on prices in 19 OECD countries.
“GLOBE is unlawful and clearly exceeds CMS' authority. The policy doesn’t make medicines more affordable for most beneficiaries, while putting future medical innovation and patient access at risk,” said Stephen J. Ubl, president and CEO of PhRMA. “We share the administration's goal of ensuring Americans can access and afford their medicines, but CMS cannot rewrite the law and bypass Congress to impose foreign price controls. Patients need more choices and more breakthroughs — not government price-setting schemes that undermine both."
PhRMA’s complaint argues that CMS is using its demonstration model authority to impose nationwide price setting policies that Congress never authorized. Specifically, the complaint contends that GLOBE:
- Fails to satisfy the statutory requirement to test a new model because it predetermines the outcome through mandatory manufacturer rebates.
- Rewrites Medicare's statutory rebate framework and expands civil monetary penalties beyond CMS' authority.
- Raises significant constitutional concerns related to the separation of powers and limits on authority delegated by Congress.
Beyond the legal considerations, GLOBE will hurt American patients and America’s biopharmaceutical leadership at a time of rising global competition:
- Minimal patient benefit: Just 0.3% of Medicare Part B beneficiaries would have seen lower out-of-pocket costs under the proposed rule, with even fewer benefitting under the final rule.
- Threatens future innovation: Artificially reducing drug prices by importing foreign price controls would reduce investment in research and development, threatening patient access and the development of future treatments.
- Imports discriminatory pricing practices: The countries used to calculate the GLOBE benchmarks rely directly or indirectly on quality-adjusted life years, or QALYs, in their pricing and coverage systems. QALYs discriminate against patients with disabilities, chronic conditions and rare diseases by assigning lower value to treatments that benefit them.
The complaint asks the court to declare GLOBE unlawful and to vacate the rule in its entirety.
A copy of the complaint filed in the United States District Court for the District of Columbia can be found here.