BIO files lawsuit challenging Medicare drug pricing pilot
Biotech industry groups sue to block Medicare pilot program linking drug prices to international rates.
Adobe (Photo via STAT)
The Biotechnology Innovation Organization (BIO) and two California-based biotech trade groups filed a legal complaint on Friday, Nov. 6, 2026, in the U.S. District Court for the Northern District of California to challenge the Global Benchmark for Efficient Drug Pricing (GLOBE) demonstration model.
The lawsuit asserts that the Centers for Medicare & Medicaid Services (CMS) exceeded its statutory authority by implementing the GLOBE model, which ties Medicare drug prices to those found in peer countries. The plaintiffs are seeking to halt the program, which serves as a test of a most-favored-nation approach to drug pricing.
John F. Crowley, the president and CEO of BIO, stated that the organization views mandatory government price-setting policies as a threat to the innovation ecosystem. The group also argued that the model fails to address the underlying drivers of health care costs and could hinder the ability of the United States to compete in the global life sciences sector.
While the immediate impact of the GLOBE model is expected to be limited due to voluntary agreements that exempted many companies, the industry is pursuing legal action to prevent the establishment of a legal precedent. This filing follows a similar lawsuit initiated last month by the Pharmaceutical Research and Manufacturers of America (PhRMA) in the U.S. District Court for the District of Columbia.
CMS has not yet provided a response to the litigation. The case is expected to serve as a test of the limits of executive branch authority regarding the regulation of drug pricing.