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G2G Bio Bulletin – March 1, 2026

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G2G Bio Bulletin – March 1, 2026

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G2G Highlights

G2G’s DC team was on Capitol Hill last week, alongside dozens of advocates and stakeholders from across the country. We met with over 40 Congressional offices, including those affiliated with the Appropriations, the Senate Health Education Labor & Pensions (HELP), the House Energy & Commerce and House Ways & Means Committees. We engaged on a wide array of issues including access and coordination of healthcare, federal R&D funding, rare disease, CMS coverage for FDA-approved products and the SBIR/STTR program.

Updates from Washington

Congress:
  • FY 2027 Appropriations: Although the President’s budget has not been released, the House appropriations process is advancing rapidly, with key committee deadlines in the next few weeks. Notably, there have been changes to Community Project Funding (CPF). Some projects are now allowed in the Labor, Health and Human Services, Education, and Related Agencies (LHHS) appropriations bill, while eligibility requirements for CPF projects in other bills, have been narrowed.
  • SBIR/STTR: There has been a major breakthrough on reauthorization. Senate Small Business Committee Chair Joni Ernst (R-IA) and Ranking Member Ed Markey (D-MA) will introduce the Small Business Innovation and Economic Security Act to reauthorize SBIR/STTR through 2031.The compromise bill will include measures that require agencies to set a cap on the number of proposals an applicant can submit per cycle, codifies large post Phase-II 'Strategic Breakthrough' awards and standardizes foreign risk disclosure requirements.
  • Other Legislation: The Senate HELP Committee voted to advance a tranche of legislation which included bipartisan bills that would prohibit insurers from discriminating against living organ donors and strengthen cybersecurity in healthcare systems.
  • Hearings:  
    • On Wednesday, Senate HELP, held a confirmation hearing for Casey Means, the President’s nominee for Surgeon General. Key highlights from the hearing include:
      • The nominee sought to center discussion on tackling chronic illness in line with MAHA priorities.
      • Committee Democrats sharply criticized the nominee on conflicts of interest, her qualifications, and views on vaccines.
      • Notably, HELP Chair Dr. Bill Cassidy (R-LA) pressed Means for her views on vaccines. She declined to fully endorse vaccination or to completely rule out linkages between vaccines and autism.
      • Senators Lisa Murkoswki (R-AK) and Susan Collins (R-ME) who sit on HELP would not commit to voting for Means, and without their support or Chair Cassidy's, she will not clear the committee vote.
      • The Surgeon General in the first Trump Administration, Dr. Jerome Adams, has urged the Senate to vote down the nomination. 
    • The House Ways & Means Committee’s Health Subcommittee convened a hearing on ‘Advancing the Next Generation of America’s Healthcare Workforce’ that featured hospital, provider and education stakeholders as witnesses. Discussion focused on: Provider shortages in rural areas, impacts of Medicaid cuts, Medicare direct graduate medical education (GME) payments, and residency programs.
    • The Senate Special Committee on Aging convened a hearing, 'From Regulator to Roadblock: How FDA Bureaucracy Stifles Innovation’ that featured rare disease stakeholders as witnesses. Discussion focused on: Inconsistencies in the FDA's application of its flexibilities to accelerate approvals, a lack of transparency and communication from the agency, political interference in decision making, and the scope of advisory committee use.
Administration & Agencies:
  • FDA:
    • The agency announced a draft guidance for industry on a new 'Plausible Mechanism Framework', that is intended to accelerate the development of therapies for ultra-rare diseases. The framework focuses on therapies to target known genetic, molecular and cellular aberrations that lead to rare conditions. The policy would allow sponsors to bypass certain requirements when addressing rare conditions where large clinical trials are not possible.
    • Starting April 1, the agency plans to provide bonuses to staff at CBER and CDER who accelerate reviews.
    • The agency has for the second time granted approval to a drug included under the Commissioner's National Priority Voucher (CNPV) pilot program. This comes just three months after the voucher was issued, and six weeks after the application was filed with FDA.
    • Commissioner Marty Makary has made statements defending his agency amid controversies surrounding CBER Director Vinay Prasad and inconsistencies in how FDA has been reviewing certain therapies. He has also opined that all drugs, aside from those that are addictive, unsafe or require monitoring, should be available over the counter.
  • CDC:
    • HHS Secretary Kennedy has added two new members to the Advisory Committee on Immunization Practices (ACIP). The upcoming meeting of ACIP is expected to address vaccine injuries and long COVID, despite those issues being outside the body's purview.
    • A coalition of states have filed a lawsuit against Secretary Kennedy, arguing that changes to vaccine policies at the federal level, as well as the lack of credibility at CDC and ACIP, hamper their ability to encourage immunization.
  • CMS:
    • National Community Pharmacists Association has written to Administrator Mehmet Oz, asking that he intervene to ensure pharmacies receive timely manufacturer rebate payments under the Medicare Drug Price Negotiation Program, amid reports of significant delays.
    • Major pharmaceutical companies have published comments opposing two proposed CMS Innovation Models, GLOBE and GUARD which would apply most favored nation (MFN) payment models to drugs under Medicare Part B and Part D respectively.
  • White House, Other HHS Divisions & Departments:
    • On Tuesday evening, the President delivered the 2026 State of the Union Address. Discussion of issues relevant to the community was limited to the President urging Congress to codify his actions on MFN pricing. There were also brief references to health savings accounts and anti-fraud measures. The Administration has followed through on the latter issue, announcing a deferral of $260 million in Medicaid funding to Minnesota and a moratorium on new suppliers of durable medical equipment at CMS, citing fraud concerns.
    • After the Supreme Court struck down tariffs he instituted via emergency-powers, the President has now instituted an across the board 10% tariff on foreign goods for 150 days, using Section 122 of the 1974 Trade Act. However, pharmaceuticals and pharmaceutical ingredients are explicitly exempted.