The House came back this week long enough to avert a government shutdown, while the Trump Administration followed through on last week’s expected expansion of its drug pricing agenda to mid-sized biopharma. We also saw new movement on biotech biosecurity and guidance on new SBIR funding rules. Here’s what we’re watching:
Trump Administration Expands MFN Deals to Nine Mid-Sized Biopharmas: On Monday, President Trump announced most-favored-nation pricing agreements with nine additional companies: Alcon, Astellas Pharma, BeOne Medicines, BridgeBio, CSL, Kyowa Kirin, Sun Pharma, Teva Pharmaceuticals, and UCB. The companies agreed to provide state Medicaid programs access to MFN pricing and made commitments around pricing of future medicines. The White House says the new agreements bring the total number of manufacturers with MFN deals to 26, representing 89% of the branded drug market, and include a combined $19.6 billion in U.S. manufacturing commitments. This round is particularly notable because the Administration’s MFN push has now moved beyond the industry’s largest manufacturers. MassBio will continue to argue that codification through Congress is not a solution and would instead lock in a policy that risks undermining investment in new medicines, particularly for smaller and emerging companies that depend on future revenue expectations to attract capital and fund R&D.
Government Funding Extended Through December; OMB Grants Rule Put on Hold: President Trump signed a bipartisan continuing resolution (CR) funding the federal government through December 11, avoiding a shutdown and maintaining federal programs largely at current levels. Importantly for the Massachusetts’ research ecosystem, the CR also prevents OMB from finalizing or implementing its proposed rewrite of government-wide federal grant rules through December 11. MassBio opposed the proposed rule, which would expand political review of discretionary grants, increase the government’s authority to terminate awards, and make other significant changes to how federal research funding is administered. The pause provides welcome near-term stability for universities and early-stage researchers, but the issue will return as Congress works toward final FY27 spending legislation after the midterm elections.
Bipartisan House Bill Targets Biosecurity Risks in DNA Synthesis: Reps. August Pfluger (R-TX) and Chrissy Houlahan (D-PA) introduced the Biosecurity Modernization and Innovation Act on August 31. The legislation would establish federal requirements for companies providing nucleic acid synthesis, including verification of customers, screening orders against a federal list of high-risk sequences, reporting suspected misuse, recordkeeping, and independent compliance reviews. The requirements would also address benchtop nucleic acid synthesizers that increasingly allow researchers to produce sequences directly. As we’ve noted in the past, Congress is increasingly focused on pairing U.S. leadership with stronger safeguards against misuse and particularly in slowing threats from global competitors. We’ll continue to advocate for effective biosecurity standards to address legitimate national security risks without creating unnecessary barriers to scientific research and biotechnology development.
FDA Expands Oversight of Foreign Clinical Trials. In an FDA Voices article, senior FDA leadership shared on September 2 that it will increase inspections of foreign clinical trial sites, including more Phase 1 and early-stage trials,and update the risk factors it uses to select foreign sites for inspection. FDA is also putting greater scrutiny on foreign studies conducted outside an IND or IDE, particularly in jurisdictions where geopolitical conditions, human-rights concerns, data integrity, or informed consent may be difficult to verify.
NIH Details New Foreign-Risk Requirements for Small-Business Funding: NIH released new guidance last week to help SBIR and STTR applicants navigate foreign-risk requirements enacted as part of this year’s Small Business Innovation and Economic Security Act. The guidance directs companies to assess not only their own ownership and personnel, but also consultants, contractors, CROs, service providers, investors, licensing relationships, and other collaborators for connections to countries of concern. NIH noted that more than half of HHS award denials involving foreign risk since 2023 have stemmed from consultants or contractors. For emerging biotechs that rely on SBIR and STTR as a source of non-dilutive capital, the guidance makes clear that foreign-risk diligence increasingly needs to extend across the entire development network.
