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Applications are open for the Shauna M. Sorrells Program

G2G Bio Bulletin – October 6, 2026

Funding Opportunity

Last Wednesday, ARPA-H announced the launch of the Simulation-augmented, Real-time Platform Adaptive Seamless Trials (SURPASS) Program, which aims leverage advanced computational models, real-time analysis, shared infrastructure, and automation to run clinical trials faster, at lower cost and with fewer participants. There is an informational webinar on October 15, a Proposer’s Day on November 6, and a Solution Summary submission deadline of November 30.

Updates from Washington

Congress:
  • The Chair of the House Energy and Commerce Committee, Rep. Brett Guthrie (R-KY) released a package of 14 bills focused on on combating fraud in Medicare and Medicaid, of which only one has bipartisan support.
  • The Senate Health, Education, Labor & Pensions (HELP) Committee by 12-11 party-line vote, advanced Surgeon General nominee Nicole Saphier for consideration by the entire chamber.
  • A resolution to block Trump Administration rules to extend catastrophic health plan durations for up to ten years and permit higher cost sharing burdens on patients on lower-tier health plans, failed to clear the simple majority threshold, 48-51. All Democrats and Sen. Susan Collins (R-ME) voted in favor.
  • Sen. Cassidy and Sen. Mark Warner (D-VA) have reintroduced a bill to facilitate specialty and mail-order pharmacy participation in surveys used to determine the National Average Drug Acquisition Cost (NADAC), which in turn influences pharmacy reimbursement rates from Medicaid and PBMs. 
Administration & Agencies:
  • ASPR: John Knox, whose views on vaccines garnered controversy, has left his role as the senior-most official at the agency. Sean Kaufman, the nominee to be the Assistant Secretary for Preparedness and Response, will assume Knox’s former role until he is confirmed by the entire Senate after the election.
  • FDA: The agency issued a final direct rule recognizing NAMs as potential nonclinical testing approaches, by removing regulatory language emphasizing animal testing as the default approach.
  • NIH: HHS Secretary Kennedy has launched a new research initiative at NIH to study vaccine injuries.
  • CMS: The agency issued final rules on the:
    • Latest iteration of the Transparency in Coverage (TIC) regulations, which requires insurers to more clearly provide information on costs to enrollees, and to remove irrelevant information in public facing material.
    • Mandatory GLOBE payment model which will calculate rebates for Medicare Part B drugs using MFN pricing, and will come into effect on January 1. Several pharmaceutical companies have been granted exemptions from participating in GLOBE, which will significantly blunt the overall impact of the program in its stated aim of lowering drug costs.
  • White House, Other HHS Agencies & Departments:
    • 340B: HRSA announced the approval of ten pharmaceutical companies’ plans to participate in its latest effort to shift the drug discount program towards a rebate model. The approval covers 22 medications, and would take effect on January 1. The response from opponents of the model is pending.
    • The second MAHA Summit was held last Tuesday, with AI in health as a major focus area, and attendance and speaking roles dominated by industry stakeholders.
    • The Administration is expected to disburse $90 checks to 20 million older Americans, to offset rising Medicare Part B premiums.