A busy week in Washington with real consequences for Massachusetts — from new legislation putting biotech licensing deals under national security review, to a sweeping OMB proposal that would hand political appointees veto power over scientific peer review. Here’s what we’re tracking, and where we stand.
Moolenaar & Dingell Introduce Legislation Putting Biotech Deals Under Outbound Investment Review: Following up on his letter from May 21 to Treasury, Select Committee on the CCP Chairman John Moolenaar (R-MI) and Rep. Debbie Dingell (D-MI) introduced the Biotech Investment National Security Act on June 2. The bill amends the COINS Act of 2025 to add pharmaceutical and biological product development to the sectors subject to outbound investment screening, making U.S. licensing deals, joint ventures, and equity investments with Chinese covered persons reviewable by Treasury. It directs Treasury to issue regulations within one year and requires a 60-day DOD security assessment. The sponsors point to roughly $136B in cross-border licensing in 2025 (up from under $5B in 2020), including Bristol Myers Squibb’s $15.2B co-development deal with China’s Hengrui. We’re tracking who else co-sponsors and whether momentum swings toward such broad provisions. We’ll keep advocating for policies that strengthen U.S. biotech at home without sacrificing international collaboration — faster trial starts, lower trial costs, efficient FDA review, increased federal R&D funding, and strong IP protections.
OMB Proposes Sweeping Overhaul of Federal Grant Rules: OMB published a proposed rule revising the Uniform Guidance for federal financial assistance in the Federal Register on May 29, with a comment period closing July 13 that seeks to bind all agencies government-wide by October 1. The proposal would require senior political-appointee review all discretionary grants and make peer review advisory rather than determinative, tie awards to a “Gold Standard Science” benchmark, expand authority to terminate active awards deemed inconsistent with agency priorities, and introduce a “domestic-first” framework limiting international research collaboration. It would also restrict a range of allowable costs (conference attendance, professional society memberships, journal subscriptions, and publication and open-access fees). Because so much of the Massachusetts pipeline originates in NIH-funded academic and hospital research, we are assessing the impact on our ecosystem and will weigh in vigorously during the comment window. Make no mistake: this is a serious threat to U.S. research and development and the discovery pipeline that turns ideas into startups, biotechs, and breakthroughs for patients. Political appointees cannot be handed this much power over peer review. Federal dollars must be earned on scientific merit — not on alignment with the politics of the moment. Science has to win the day, and we’ll fight to keep it that way.
House Judiciary Holds “Medicines and IP” Hearing Thursday: The House Judiciary Subcommittee on Courts, Intellectual Property, Artificial Intelligence, and the Internet holds its hearing, Medicines and IP: Balancing Innovation and Access, on Thursday, June 4 at 10:00am. Witnesses are Krista Carver (Partner, Covington & Burling); Michael Carrier (Board of Governors Professor, Rutgers Law School); Rachel Goode (SVP and Head of Legal and Intellectual Property, Fresenius Kabi); and Jamie Simpson (Chief Policy Officer and Counsel, Council for Innovation Promotion). We’ll be listening for how members frame the role of IP in driving biotech innovation.
NIH SBIR Reopens with New SBIR/STTR Opportunities and New Strings Attached: Following the reauthorization of the SBIR and STTR programs, NIH announced June 1 that its Small Business program is back online, with new Notices of Funding Opportunity now posted and deadline of Tuesday, September 8. Three policy changes are worth flagging for members: HHS has capped each company at nine SBIR/STTR applications per fiscal year (NOT-OD-26-073); tightened foreign-risk and disclosure rules, with HHS now obligated to tell a company which risk category triggered a denial (NOT-OD-26-074); and expanded Technical and Business Assistance (TABA) funds to cover cybersecurity, foreign-risk screening, and, for the first time, paying employees rather than only outside vendors (NOT-OD-26-075). NIH is running an applicant-support webinar on June 9 at 1:30 p.m. ET to walk through the new opportunities and policy changes, with follow-on sessions July 21 and August 18 on budgets and the foreign-risk process. More info here.