MassBio CEO & President Kendalle Burlin O’Connell originally posted this update on LinkedIn.
Five policy stories this week. One common thread: the rules that govern how you build, price, and sell medicines in America are being rewritten in real time, and those rules (and the people making them) keep changing faster than any company can plan around them.
Makary out at FDA: After days of speculation, FDA Commissioner Marty Makary resigned Tuesday, capping a 13-month tenure marked by leadership turnover, contested rejections, and tensions with both the White House and industry. Kyle Diamantas, previously Deputy Commissioner for Human Foods, has stepped in as Acting Commissioner, and HHS Secretary Kennedy has said the search for a permanent replacement is “already underway.” The Senate Appropriations Subcommittee on Agriculture, Rural Development, FDA, and Related Agencies hearing on the FY27 budget, at which Makary had been scheduled to testify this week, was postponed and has not yet been rescheduled. With CBER also under acting leadership following Vinay Prasad’s departure at the end of April, this is the second top-of-house transition at FDA in two weeks. The operational implications of compounded leadership uncertainty are real, and we’ll be tracking who is nominated and what it signals about the agency’s direction.
Commerce releases application procedures for company-specific onshoring agreements: On Wednesday, the Department of Commerce published its long-awaited procedures for pharmaceutical companies to apply for the company-specific Onshoring Agreements that unlock tariff relief under the President’s April Section 232 proclamation. Applications are due June 12. Companies with approved onshoring plans qualify for a 20% tariff rate rather than the default 100%; those that pair an onshoring agreement with an HHS MFN pricing agreement qualify for 0% through January 2029. The procedural guidance specifies the detailed organizational, manufacturing, and milestone documentation companies must submit, with periodic reporting and the possibility of retroactive tariff increases if commitments aren’t met. Massachusetts-headquartered companies and the many global companies with significant Cambridge and Boston operations now have a concrete (and tight) timeline to evaluate whether and how to engage.
Trump visits China without Large Pharma: President Trump arrived in Beijing this week for his first state visit to China since 2017, accompanied by a delegation that included Tim Cook, Elon Musk, and other tech leaders, but notably no pharmaceutical CEOs. That stands in contrast to recent visits by U.K. and German leaders, who brought their pharma chiefs along to announce major China investments. The omission lands amid a clear shift in Washington’s posture toward U.S.–China life sciences integration. The trip coincided with this week’s announcement of a global licensing deal between Hengrui Pharma and BMS valued at up to $15.2 billion, a reminder of how deeply intertwined the U.S. and Chinese biopharma pipelines have become, even as Washington considers efforts to decouple.
Reconciliation 3.0 on the horizon: While Reconciliation 2.0 (the narrowly-tailored immigration enforcement package) is still working its way through Senate, House Republicans are already eyeing a third reconciliation vehicle for this summer. Speaker Johnson has signaled interest in a follow-on package and House Republican Study Committee Chair August Pfluger said he expects to have it completed by August recess. House Budget Chair Arrington has previously pitched another Reconciliation vehicle “as the path to lower healthcare costs.” Senate Republicans are cooler on the timeline, with several skeptical a third bill can come together before the August recess, let alone before the November midterms. We’ll be watching closely for any provisions that might impact MA biotechs as conversations continue.
Looking Ahead: Senate Armed Services Subcommittee on Emerging Threats and Capabilities will hold a hearing on May 19 to examine science and technology priorities in review of the Defense funding request for FY27. Biotechnology featured prominently in FY26 NDAA and the Administration’s FY27 request again maintains focus in this area. Biomanufacturing is listed among six critical technology areas and priorities include identification of adversary biotechnology advancements, establishing systems to protect domestic biotechnology innovation, and providing continued funding to the Distributed BioIndustrial Manufacturing Program (DBIMP) focused on building and securing U.S. bioindustrial manufacturing.