Press Release: 11/23/2025

CEO Innovation Policy Update: 11.21.25

 



NOV 21, 2025



The following was originally posted by MassBio CEO and President Kendalle Burlin O’Connell to LinkedIn on November 21, 2025:



With the federal government officially reopened, attention in Washington is back to a packed policy agenda that brings both new opportunities and fresh concerns for the life sciences. Congress is weighing end-of-year health care negotiations and broader proposals that could reshape drug pricing and innovation, and the stakes are high for patients and the biotech ecosystem. MassBio is engaging aggressively to ensure that any emerging policies strengthen, rather than strain, America’s leadership.




  1. End-of-Year Healthcare Package Rumors: Talks are picking up again about an end-of-year health care package. MassBio is urging our delegation to pair any package with policies that support innovation here in Massachusetts, starting with the EPIC Act to fix the Pill Penalty and restore parity for small-molecule drugs, and meaningful PBM reforms that increase transparency and ensure savings reach patients at the pharmacy counter. In a Senate Finance Committee hearing on “The Rising Cost of Health Care: Considering Meaningful Solutions for all Americans” earlier this week, Chair Crapo shared in remarks that he’ll soon be introducing bipartisan legislation to “enact pharmaceutical benefit manager (PBM) reform, which would realign incentives in the drug supply chain to lower patient costs at the pharmacy counter.” We’ll be watching closely in the coming weeks as leadership decides what, if anything, can make it onto a year-end vehicle.

  2. House Democrats Seek to Massively Expand IRA Price Negotiations: House Democratic health leaders are proposing to expand the Inflation Reduction Act’s drug price negotiation program from 20 to 50 drugs per year, undue provisions of the Big Beautiful Bill that exempted orphan drugs for multiple rare diseases from Medicare drug price negotiation, and require the health secretary to consider the price of a drug in other developed countries while negotiating the U.S. price. A dramatically larger and more sweeping negotiation regime raises red flags for investment, especially in areas like rare disease and oncology. MassBio will continue to engage with Members of Congress to highlight the impact on our pipeline and to push for targeted fixes like EPIC rather than broad expansions of government price setting.

  3. U.S. overreliance on Chinese APIs Discussed in New Report: A new report from the U.S.–China Economic and Security Review Commission highlights U.S. reliance on drug supply chains: while most drugs Americans take are low-cost generics, anywhere from one-quarter to one-half of those products rely on active pharmaceutical ingredients (APIs) derived from China. The report suggests Congress should direct FDA to produce a confidential report outlining vulnerabilities to Chinese APIs and KSMs.  

  4. Congress Signals a Prioritization of U.S. Biomanufacturing: The report comes at a time where many in Congress are prioritizing efforts to enhance U.S. biomanufacturing. Earlier this week, Reps. Houlihan, Baird, Rouzer, and Ross and senators Coons and Budd introduced the Biomanufacturing Excellence Act which would promote public-private partnerships for scaling biopharmaceutical manufacturing. Also this week, Senate Aging Committee held a hearing on Restoring Trust in Our Medicines. Committee Chair Rick Scott shared in his remarks, “nearly 80 percent of the active ingredients in our prescription drugs come from foreign sources. That means we depend on our adversaries for the very medicines our families and seniors need to survive…This isn’t just an economic issue; it’s a matter of national security.” These recent actions signal a continued emphasis on supporting U.S. Biomanufacturing from Congress in 2026.

  5. FDA Continues Efforts to Improve Efficiency in Clinical Trials: FDA has launched a new pilot giving sponsors a short, three-business-day window to request quick clarifications to formal meeting minutes by email. The pilot is aimed at cutting “months of guesswork” allowing drug sponsors to focus on delivering innovative treatments. For Massachusetts companies trying to keep clinical programs on track in a tighter capital environment, anything that makes FDA interactions more predictable and reduces back-and-forth can shave time and cost off development. MassBio appreciates these efforts and looks forward to working with FDA on additional measures to modernize the regulatory trial process.