MassBio CEO & President Kendalle Burlin O’Connell originally posted this update on LinkedIn.
With the House already recessed and the Senate preparing to leave Washington until after the November elections, activity in Congress will largely go quiet in October. But several significant developments this week are worth watching for Massachusetts biotechs, including the finalization of the GLOBE drug pricing model, a new federal push to modernize clinical trials, and continued uncertainty around pharmaceutical tariffs.
CMS Finalizes GLOBE, Putting International Reference Pricing into Medicare Part B: CMS on Wednesday finalized the mandatory Global Benchmark for Efficient Drug Pricing (GLOBE), Model, which will tie reimbursement for certain Medicare Part B medicines to prices in a basket of 19 other developed countries beginning January 1, 2027. The final model is substantially narrower than initially proposed: CMS now projects approximately $440 million in savings over seven years, compared with an earlier estimate of nearly $12 billion. Even with its narrower scope, GLOBE represents a troubling expansion of international reference pricing into Medicare that MassBio strongly opposes. In our comment earlier this year, we wrote, “The proposed Model would significantly undermine incentives for innovation in the United States and put patient access to the latest innovations at risk, without meaningfully increasing patient access or reducing patient costs.”
HHS Launches Major New Push to Make U.S. Clinical Trials Faster: HHS and ARPA-H announced a new initiative this week aimed at fundamentally changing how clinical trials are designed and conducted. The effort, known as Simulation-augmented, Real-time Platform Adaptive Seamless Trials (SURPASS), would use adaptive trial designs, shared infrastructure, real-time data analysis, computational modeling, and digital twins to reduce development timelines, costs, and patient burden. Administration officials explicitly framed the effort as part of a broader push to strengthen U.S. competitiveness in clinical development. For Massachusetts companies, the program is another sign that clinical-trial modernization is becoming a central federal biotech competitiveness priority.
Pharmaceutical Tariffs Take Effect with Significant Carveouts: The Administration’s Section 232 tariffs on certain patented medicines and pharmaceutical ingredients took broader effect September 29, just days after the Commerce Department issued new guidance defining which specialty products may qualify for zero-tariff treatment. The guidance provides exemptions for certain products including cell and gene therapies, antibody-drug conjugates, and drugs used solely for clinical trials or R&D, but eligibility can depend on product classification, country of origin, and other conditions, while companies seeking an “urgent U.S. health need” exemption must apply on a product-by-product basis. The exemptions are not automatic and questions have lingered over how Commerce will process requests and how tariff liability will be handled while applications are pending. If your company has encountered challenges determining whether a product qualifies for an exemption, navigating the application process, or understanding how the tariffs apply to your supply chain, please let the MassBio team know as we continue to engage policymakers on implementation.
FDA Commissioner Nomination Will Wait Until After the Midterms: Dr. Heidi Overton, President Trump’s nominee to lead FDA, will not receive a Senate vote before lawmakers leave Washington for the November elections, extending the leadership uncertainty at the Agency into at least November. Overton appeared before the Senate HELP Committee last week, where senators questioned her on issues including foreign clinical trials, vaccines, drug safety, and FDA independence.
