BIO, Biocom, and California Life Sciences Sue to Block CMS GLOBE Rule

Complaint argues HHS and CMS exceeded statutory authority; rule puts patient access, investment in future innovation, and America’s long-term biotechnology leadership at risk.

WASHINGTON, DC & SAN DIEGO, CA & SAN FRANCISCO, CA - The Biotechnology Innovation Organization (BIO), Biocom, and California Life Sciences (CLS), today filed a complaint in the Northern District of California challenging a final rule from the Centers for Medicare & Medicaid Services (CMS): the Global Benchmark for Efficient Drug Pricing Model (GLOBE).

The groups, which collectively represent more than one-third of America’s biotech companies, contend that CMS, in finalizing the GLOBE model, exceeded its statutory authority to test payment and service delivery models that address a defined population with deficits in care. GLOBE rewrites the Medicare statute to force American biotech innovators to rebate the difference between the price of certain Medicare Part B medicines in the US and government-controlled prices in 19 foreign countries, effectively importing foreign price controls. The groups also assert that GLOBE violates appropriations law and constitutional principles, including the separation of powers and non-delegation doctrines.

"Patients need policies that lower their prescription costs without jeopardizing access to new medicines today and in the future," said Joe Franklin, Chief Legal and Policy Officer, BIO. "By finalizing the GLOBE model, CMS crossed the limits Congress placed on its authority, and ultimately, put patients, innovators, and American competitiveness at risk. We cannot - and should not - import policies that leave Americans behind and threaten American leadership in global biotechnology."

GLOBE fails to meaningfully address access and affordability challenges Americans face and will instead cause irreparable harm to the future of biomedical innovation and America’s most vulnerable patients waiting for cures. A January 2026 analysis found that just 0.3% of Part B beneficiaries would have seen lower out-of-pocket costs under the GLOBE proposed rule. 

“Most favored nation price controls won't make health care more affordable – they'll only undermine our ability to develop new cures and treatments patients are desperately seeking," said Mike Guerra, California Life Sciences President, and CEO. “The GLOBE model is a fundamentally flawed approach that will starve the biomedical innovation pipeline without making healthcare more affordable for patients. In order to truly help patients, we must address the glut of health insurance-owned middlemen who drive massive costs to our health care system and patients."

“While we appreciate the Administration’s goal to make medicines more affordable for American patients, we strongly oppose the most-favored-nation GLOBE model for importing foreign price controls into the United States, which would set a dangerous precedent with no corresponding benefit to patients,” said Tim Scott, Biocom’s President, and CEO. “The U.S. produces two-thirds of the world’s new medicines, and California leads the world in biomedical innovation. Price controls have been shown to reduce both innovation and patients’ access to medicines in the countries where they are implemented. Biocom has repeatedly warned about the damages such policies would have on the research and development of new treatments and the disproportionate impact on small and mid-size companies.”

The biotechnology industry has vocally opposed GLOBE since it was proposed in December 2025, providing detailed comments on the illegality of the model and its damaging impact on American patients and biotech innovators, including small-to-mid-size companies, which are responsible for more than half of all medicines that are approved in the USⁱ.

The complaint is available online here. Comment letters from BIO, Biocom, and CLS are also available.