G2G Bio Bulletin – July 13, 2026
Updates from Washington
Congress: Activity was limited as both chambers were in recess this past week.
- Senate Appropriations Committee Chair Susan Collins (R-ME) has written to Russell Vought, Director of the Office of Management and Budget (OMB) requesting a comment period extension of at least 90 days, for the proposed rule that would significantly overhaul federal grants oversight and disbursement. As of now, the comment window is scheduled to close on July 13. Sen. Collins also called for the withdrawal of provisions in the rule that would facilitate at-will termination of awards and deemphasize peer review.
- Senate Aging Committee Chair Rick Scott (R-FL) has written to Jamieson Greer, the US Trade Representative, proposing application of additional tariffs on generic pharmaceuticals imported from China that were manufactured using forced labor.
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A bipartisan coalition, led by Sen. Todd Young (R-IN) filed an amendment titled the American Biotechnology Competitiveness Act, to the Senate’s version of the FY 2027 National Defense Authorization Act (NDAA), that is up for a vote by the chamber this coming week. The measure combines several recommendations of the National Security Commission on Emerging Biotechnology (NSCEB), which Sen. Young chairs. Provisions include establishing:
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Screening requirements for gene synthesis products, directing companies in this sector to verify their customers and intended end-uses.
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A Biotechnology Governance Sandbox at NIST, which among other functions would facilitate secure testing of biosecurity, biosafety and other biotechnology innovations.
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Streamlined biosecurity and biosafety authorities across the government.
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Requirements for NIST to establish and disseminate definitions, standards, resources and frameworks to ensure that biological datasets can be used to train AI models and support further innovation at the intersection of AI and biotech.
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A National Programmable Cloud Labs Network to maintain American AI leadership, and improve collaboration and scientific reproducibility. The network is authorized at a level of $30 M per year, for five fiscal years.
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A National Biopharmaceutical Innovation Center at NIST to support advanced biomanufacturing innovation. This is authorized at a level of $40 M per year, for three fiscal years.
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- Last Monday, a bipartisan group of House members introduced the SECURE 340B Act to reform the drug discount program. The legislation focuses on closing loopholes that the sponsors argue has diverted federal dollars away from the intended low income patient recipients. The bill:
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Establishes a statutory definition of 340B eligible patients
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Pauses manufacturer rebate models for four years, while other reforms to pharmacy standards and transparency rules are implemented.
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Empowers the Health Resources and Services Administration (HRSA) with new authorities, and directs the agency to use an independent management system for verification of claims and prescription-level data.
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Administration and Agencies
- FDA:
- The agency has proposed a rule, that would streamline registration for distributed manufacturing components operating under a hub and spoke model, and clarify registration requirements for foreign entities producing drugs and active pharmaceutical ingredients that get incorporated into the US medicine supply chain. Comments on the proposal must be submitted by September 11.
- CMS:
- The agency has has announced that it will no longer fast-track renewals of Medicaid pilot programs launched by states under the Section 1115 waiver scheme. This comes one month after the agency indicated it would be pursuing more rigorous oversight of the program.
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A measure in the One Big Beautiful Bill Act (OBBA) barring Medicaid reimbursement for reproductive healthcare services at certain clinics has lapsed.
- White House, Other HHS Agencies & Departments
- Administration officials including HHS Secretary Kennedy met with leaders of major pharmaceutical firms, where both policy and industry initiatives to on-shore production of essential medicines were discussed.
- The spectrum of injuries that claimants can request compensation for through the Countermeasures Injury Compensation Program (CICP), is expected to be expanded to include those linked to COVID-19 vaccines, according to a proposed rule published earlier this month.
Reminder: Don’t miss the monthly GBG Report call every third Thursday of the month at 12 pm ET where the team discusses the latest federal life sciences funding opportunities. G2G has raised $624M and is eager to share our expertise to help companies grow and accelerate bringing innovations to patients.