MassBio CEO & President Kendalle Burlin O’Connell originally posted this update on LinkedIn:
DC may be catching its breath this week, but the policy landscape for biopharma is anything but quiet. Here’s what we’re tracking heading into a busy stretch on Capitol Hill and beyond.
Congress in Recess + State of the Union: The House & Senate are in recess this week, so much of DC has turned its attention to next week’s State of the Union (Tuesday, February 24, 2026). We’ll be watching closely for how President Trump discusses his health care priorities, including whether he continues to push Congress to codify “Most Favored Nation” (MFN) drug pricing or related proposals that could ripple through the innovation ecosystem. We’ll share a full readout following the address.
Upcoming Hearings We’re Watching: Congress is back at it next week, and we’ll be watching a few hearings in particular, including: The House Ways & Means Health Subcommittee’s “Advancing the Next Generation of America’s Health Care Workforce” (Tuesday, February 24, 2026), where we look forward to hearing how Members discuss how to grow and support the workforce pipelines that directly shape Massachusetts’s competitiveness across R&D, clinical care, and advanced manufacturing. Additionally, we’re also watching the Senate Special Committee on Aging’s “From Regulator to Roadblock: How FDA Bureaucracy Stifles Innovation” hearing (Thursday, February 26, 2026). Dr. Jeremy Schmahmann, Director of the
Massachusetts General Hospital Ataxia Center, is among those testifying at the latter.
Cassidy/Senate HELP FDA Modernization White Paper: Earlier this week, Senate HELP Chair Bill Cassidy released a report laying out legislative and regulatory proposals to “modernize” FDA, framing the goal as reducing unnecessary bottlenecks while sustaining U.S. biomedical leadership and getting patients timelier access to new treatments. We’re pleased to see initial efforts to increase predictability and efficiency for small innovators, such as establishing clearer expectations and smoother pathways for novel trial approaches. We look forward to working with our members, Senator Cassidy, and the Committee to ensure all challenges and options are being considered.
FDA Moving Away from “Two-Study” Expectation: In a New England Journal of Medicine commentary published earlier this week, FDA Commissioner Martin Makary and Vinay Prasad outlined their goal to move away from the long-standing norm of requiring two rigorous studies for many approvals toward one adequate and well-controlled study plus confirmatory evidence in certain cases. They acknowledge that advances in drug research have made overreliance on two trials unnecessary. This move represents a big potential shift for development strategy, timelines, and investment decisions, and could lead to significant cost savings and shorter timelines for biotechs.
FDA Reversal on Moderna’s mRNA Flu Vaccine Review: This week, FDA reversed course and agreed to review Moderna’s application for its mRNA-based flu vaccine after it had announced that it had rejected its application for review a week prior. The sudden reversal is welcome but continues to highlight an uncertain regulatory environment for vaccine developers.