GBG Bio Bulletin July 27, 2026
G2G Updates
G2G has been busy on Capitol Hill! We’ve connected with several key Members of Congress over the past two weeks including:
- Rep. Jason Smith (R-MO), Chair of the House Ways & Committee: Discussed the importance of the SBIR/STTR program for the life sciences sector, particularly immediate R&D expense amortization, as well as changes to the physician fee schedule (PFS) amid budget neutrality requirements.
- Sen. Susan Collins (R-ME), Chair of the Senate Appropriations Committee: We thanked the Chair for advocating for significant revisions to the Office of Management and Budget’s proposed overhaul of federal grantmaking and her continued support for peer and merit-based review. We also discussed the outlook for key health and innovation programs as part of the stalled Senate appropriations process.
- Rep. Marcy Kaptur (D-OH), Senior Member, Defense Subcommittee, House Appropriations Committee: Discussed defense innovation priorities and the outlook for a final FY 2027 defense budget package.
- Rep. Morgan Griffith (R-VA), Chair, Health Subcommittee, House Energy & Commerce Committee: We thanked the Chair for his leadership in shepherding several bipartisan health priorities through the committee process, and the outlook for future health policy markups.
Updates from Washington
Congress:
- FY 2027 Appropriations: On Monday, the House voted 220-205 to pass a continuing resolution to fund the government through December 6, and avert a shutdown at the start of FY 2027 on October 1. All but one Republican voted in favor, and all but six Democrats voted in opposition.
- FY 2027 National Defense Authorization Act (NDAA): On Wednesday, the House voted 216-212, to pass its version of the NDAA authorizing $1.15 T in defense spending. All but seven Republicans voted in favor, and all but six Democrats voted in opposition.
- Reconciliation 3.0: On Wednesday, the House voted 216-214 to pass a $95 B bill on Republican spending priorities,including the Iran War. Two Republicans joined all Democrats in opposing the measure. President Trump has asked the Senate to take up the resolution before adjourning for August recess.
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Healthcare Legislation: The House overwhelmingly passed several bipartisan health measures that had previously cleared the Energy & Commerce Committee including:
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FDA Modernization Act 3.0: Requires HHS to replace certain regulations on animal models with corresponding measures on nonclinical models
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DeOndra Dixon INCLUDE Project Act of 2025: Authorizes NIH program on Down syndrome and its co-occuring conditions
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NIH IMPROVE Act: Authorizes NIH maternal health research initiative to reduce mortality and morbidity
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Reauthorization of programs on TBI, dental workforce, tick-borne diseases, Alzheimer’s care provider training, ALS research, stem cell research and educational resources for early detection of breast cancer (EARLY Act).
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Nomination Votes Postponed: CDC Director nominee Dr. Erica Schwartz earned the endorsement of Senate Health, Education, Labor, and Pensions (HELP) Committee Chair Sen. Bill Cassidy (R-LA), but a committee vote on her nomination was delayed due to quorum issues, and will take place next week. The vote on the assistant secretary for preparedness and response (ASPR) nominee, Sean Kaufman was delayed due to insufficient support.
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- Committee Hearings, Legislation and Other Activity:
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House Energy & Commerce: On Monday, the Committee convened to consider 29 bills, including several in the healthcare space:
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Price and Data Transparency: The Lower Costs, More Transparency Act, sponsored by the Chair Brett Guthrie (R-KY) and Ranking Member Frank Pallone (D-NJ), which would require healthcare providers to publicly post fees for common services and insurance plans to publish rates, cleared the Committee unanimously. It was amended to include bills requiring: 1) Medicare Advantage plans to provide clearer information on payment rates and cost sharing for beneficiaries, adopt streamlined electronic prior authorization systems and submit enrollee-level data on supplemental benefits to HHS and 2) Commercial plans to disclose how premium dollars are spent and to publish a list of services requiring prior authorization, as well as data on various metrics including denial rates. A separate bill led by Rep. Marianette Miller Meeks (R-IA) requiring providers to post discounted cash prices for services, passed on a party-line vote of 24-21.
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Generics & Biosimiliars: Bills to deem biosimilar drugs to be interchangeable with name-brand counterparts upon FDA approval, modernize the approval process for biosimlars and crack down on abuse of citizen petitions stalling approval of generics, passed unanimously.
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Community Health Centers (CHCs: Bills to support nutrition and mental health and substance use disorder services advanced unanimously.
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Drugs and Illicit Substances: Bills on fentanyl testing in ER settings, nitazenes, xyalzines, support for rapid drug detection strips, mitigating opioid overdoses and counterfeit pills were all advanced.
- House Oversight: The Committee marked up several bills including one that would regulate pharmacy benefit managers (PBMs) as part of their engagements with federal employee health plans.
- House Science, Space, and Technology: On Wednesday, the Committee convened a hearing on 'Unleashing the Golden Age of Science: Examining the Priorities of the FY2027 Research and Technology Enterprise’. The hearing featured testimony from Michael Kratsios, the Director of the Office of Science & Technology Policy (OSTP) to discuss priorities outlined in the President’s Budget Request.
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Senate HELP: On Wednesday, the Committee convened and advanced several bills for consideration by the full chamber including:
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Approved Unanimously:
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The National Plan For Epilepsy Act: Requires HHS to provide a national framework geared to examining and improving epilepsy care and therapies.
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Expedited Access to Biosimilars Act: Eliminates redundancies in biosimilar approval. This is non-identical to the measure with the same name advanced by House Energy & Commerce.
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Approved Overwhelmingly:
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Patients Deserve Price Tags Act: Requires providers and insurance plans to publish rates and prices, provide itemized bills, explanation of benefits and strengthen enforcement mechanisms among other measures. This is not directly linked to similar measures advanced by House Energy & Commerce.
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CLEAR LABELS Act: Adds country of origin labeling requirements to the US prescription drug supply chain
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Rural Obstetrics Readiness Act: Aids healthcare practitioners in rural areas in addressing obstetric emergencies
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The SAFE Drugs Act of 2026: Expands safety and transparency requirements in the pharmacy compounding industry
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INSULIN Act of 2026: Caps out-of-pocket insulin costs at $35 per month
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Approved Narrowly:
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Childhood Diabetes Reduction Act of 2026: Championed by Ranking Member Bernie Sanders (I-VT) the bill would expand warning labels on ultra processed food and prohibit junk food advertising targeted at children. It passed 12-10, with Chair Cassidy, Sen. Roger Marshall (R-KS) and all but one Democrat voting in favor.
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- Senate Commerce: On Tuesday, the Subcommittee on Science, Manufacturing, and Competitiveness convened a hearing on 'Measuring What Matters: Science, Standards, and Strategic Competition.’ The hearing featured testimony from Dr. Drew Endy, the Director of Bio-Strategy and Leadership at the Hoover Institution, Walter Copan of the Colorado School of Mines, Dr. Robert Atkinson of the Information Technology and Innovation Foundation and Dr. Julia Phillips, a Science Policy Advocate. Discussion was dominated by concerns of increasing Chinese domination in scientific enterprise. Key highlights include
- Dr. Endy discussed the dire need for a biomeasurement laboratory at NIST, and that China is leading biotechnology standards setting amidst a US leadership vacuum.
- Dr. Atkinson advocated for research models focused on strategic national priorities, and industry friendly policy measures to achieve this
- Sen. Todd Young (R-IN) discussed the need for data standards at the intersection of AI and biotech, and highlighted his bills to treat biological data as a strategic asset, and to codify the Center for AI Standards and Innovation.
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Administration & Agencies:
- FDA:
- In response to criticism, the agency’s Pharmacy Compounding Advisory Committee (PCAC) added additional peptide subject matter experts to its roster. PCAC convened this past Thursday and Friday, and released recommendations easing restrictions on access to certain peptides.
- The agency updated its tracking of cyclospora infections to include 72 cases of unknown origin, following earlier confirmations of cases tied to iceberg lettuce sourced from the Taylor Farms group.
- CMS:
- The Trump Administration is withholding $1 B in Medicaid payments to California and Minnesota, citing an audit that indicated instances of fraud in those states’ programs
- The agency announced a proposed rule to prevent states from raising revenue through provider taxes and drawing additional federal matching funds for their Medicaid programs. Comments on the rule are being accepted through September 21.
- CDC:
- A federal district judge who had previously ruled against HHS Secretary Kennedy’s overhaul of the Advisory Committee on Immunization Practices (ACIP) has issued a stay of his decision in anticipation of a higher court imminently ruling on the same topic.
- The agency reported that there are now over 2,300 confirmed measles cases, the highest incidence in over three decades.
- White House, Other HHS Agencies & Departments:
- Science Policy: Accompanying Director Kratsios' appearance before the House, on Tuesday OSTP released its report "Science: A New Golden Age” on its vision for a new R&D policy, spanning several federal agencies and departments. The report focuses heavily on AI and positions itself as an heir to Vannevar Bush’s 1945 report that shaped the current federal R&D structure. Report highlights include:
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Refocus R&D on individual investigators rather than traditional academic research institutions and stand up more ARPA-like groups in the federal research enterprise
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Prioritize mission-driven scientific initiatives uniting government, academia, industry and philanthropy
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Fund and scale the Genesis Mission to advance AI for science including for discovery, development of high-value data sets, AI-enabled verification infrastructure and autonomous labs. Notably, the Administration on Wednesday unveiled more than $5 B in commitments via Genesis including for scaling bioindustrial capabilities, accelerating drug discovery, tackling chronic disease and early detection of biological threats.
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Integration of vocational education and training into STEM education,
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- 340B: A federal court has ruled that HHS was within its authority to deny 340B rebate model proposals pushed for by major pharmaceutical companies. The department is separately weighing its own revised proposals on a 340B rebate model, after a previous attempt to do so failed late last year.
- Tariffs: President Trump has threatened to impose 100% tariffs on imported generic drugsif companies making them do not shift production to the US by August 2028. Experts have indicated that generics manufacturers will likely pull out of the US market entirely, unlike in the case of branded pharmaceutical products. Separately, following the expiration of previous temporary tariffs, the Administration on Thursday announced the implementation of tariffs of 10-12.5% on goods from sixty countries under the reasoning that those nations have taken insufficient actions against forced labor.
- Substance Abuse and Mental Health Services Administration (SAMHSA): The Administration announced that agency’s current chief of staff, Dr. Timothy Westlake, is the nominee to head the agency on a permanent basis. The position has been unfilled since the Trump Administration took office.
- Science Policy: Accompanying Director Kratsios' appearance before the House, on Tuesday OSTP released its report "Science: A New Golden Age” on its vision for a new R&D policy, spanning several federal agencies and departments. The report focuses heavily on AI and positions itself as an heir to Vannevar Bush’s 1945 report that shaped the current federal R&D structure. Report highlights include:
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.