Three biotechnology trade groups filed a lawsuit Nov. 6 challenging CMS’ Global Benchmark for Efficient Drug Pricing Model, known as GLOBE, arguing the agency exceeded its statutory authority in finalizing the model.
The Biotechnology Innovation Organization, Biocom and California Life Sciences filed the complaint in the U.S. District Court for the Northern District of California. The groups, which collectively represent more than one-third of U.S. biotech companies, contend that the model violates federal appropriations law and constitutional principles, including the separation of powers.
Under GLOBE, manufacturers of certain Medicare Part B drugs would be required to pay rebates based on the difference between U.S. prices and government-controlled prices in 19 foreign countries. The groups argue that federal law limits CMS to testing models that address a defined population with deficits in care.
The organizations also warned that the policy could restrict patient access to treatments and discourage drug development. They cited a January 2026 analysis finding that just 0.3% of Medicare Part B beneficiaries would have seen lower out-of-pocket costs under the proposed rule.
The groups said the biotechnology industry has opposed GLOBE since CMS proposed it in December 2025, citing concerns about its potential effects on smaller drugmakers and future investment in treatments.
