G2G Bio Bulletin – April 20, 2026

• Congress: Both chambers reconvened this week.
  • FY 2027 Appropriations: House appropriators intend to rapidly complete all twelve spending bills for the next fiscal year, with relevant markups scheduled almost every week from now until June. By contrast, Senate appropriators are not expected to commence their markup process until June.
  • Hearings on the HHS Budget Request: Secretary Kennedy appeared before House committees to discuss his department’s budget request. He highlighted Administration initiatives on drug prices, chronic health, rural healthcare and dietary guidelines, while attempting to reduce discussion of vaccine policy. Republican members largely praised the Secretary’s work and the MAHA agenda, while Democrats criticized cuts, funding disbursement delays, and wider policy changes. Highlights on specific agencies or issues are as follows:
    • House Appropriations Committee, Labor, Health & Human Services and Related Agencies Subcommittee: 
      • NIH: Subcommittee Chair Robert Aderholt (R-AL) reiterated his support for NIH investments, and notably remarked that "extreme swings in funding supporting biomedical research are counterproductive” and that it is unlikely that Administration’s proposed cuts to NIH would advance.
      • Vaccines: Rep. Lois Frankel (D-FL) criticized the department for delaying the release of over $300 M in funds for vaccines appropriated to Gavi, while Rep. Madeleine Dean (D-PA) got the Secretary to affirm that the MMR vaccine is “safe for most people."
      • Resilience, Biodefense and Medical Countermeasures: In response to Reps. Jake Ellzey (R-TX) and John Moolenaar (R-MI), the Secretary highlighted that the proposal includes robust funding for ASPR/BARDA and the Strategic National Stockpile. He noted the provision of $325 M to onshore API and pharmaceutical production, and indicated openness to expanding BARDA’s flexible contracting authorities to execute on this.
      • FDA: The Secretary highlighted proposed efforts to accelerate drug approvals in response to China overtaking the US in the number of Phase I clinical trials and expand access to investigational drugs.
      • Maternal Health: In a discussion with Rep. Julia Letlow (R-LA), the Secretary highlighted the Perinatal Pilot Program that provides maternal health protocols to over 200 hospitals, and which he stated has correlated with a 42% decrease in maternal mortality at those facilities.
    • House Ways & Means Committee:
      • Medicare Innovation: Secretary Kennedy expressed his view that the Center for Medicare and Medicaid Innovation (CMMI) was mismanaged, and that the Administration was reorienting it to its core mission. Rep. Suzan DelBene (D-WA) expressed her concerns on the CMMI's WiSER model and wider implications of using AI in healthcare decision making.
      • FDA Management: In response to questioning from Rep. Darin LaHood (R-IL) on media reports on challenges at the agency, the Secretary pushed back with a defense of FDA Commissioner Marty Makary, noting the rapid approval of devices and new and generic drugs.
      • Breakthrough Devices: Rep. Blake Moore (R-UT) discussed the Ensuring Patient Access to Critical Breakthrough Product Act, to provide   provisional CMS coverage FDA breakthrough designated products. The Secretary indicated that HHS will have an announcement on agency policy on this issue soon.
    • House Education & Workforce Committee:
      • Pharmacy Benefit Managers (PBMs): In response to questioning from Reps. Rick Allen (R-GA) and James Comer (R-KY), Secretary Kennedy noted Administration efforts to delink drug list prices from PBM compensation rates and to reduce vertical integration.
  • Other Hearings:
    • Senate Health, Education, Labor & Pensions (HELP) Committee held a hearing Making Medicines More Affordable. Key highlights:
      • Chairman Sen. Bill Cassidy (R-LA) highlighted measures to accelerate biosimilar approval, while preserving incentives to innovate through patent protections. PBMs were cited as barrier to biosimilar adoption. He highlighted the Ensuring Timely Access to Generics Act and the Biosimilar Red Tape Elimination Act to achieve these aims.
      • Senators either praised or sharply criticized the TrumpRx program, depending on party affiliation. Democratic Senators noted the role of the IRA in facilitating Medicare negotiations on drug pricing.
      • Witnesses discussed strategies to hasten drug approvals while reducing costs, including decentralized clinical trial participation that is integrated into primary care, and leveraging AI to improve selection of worthy drug candidates before of commencing any clinical trials.
    • House Energy & Commerce - Health Subcommittee: Legislative Proposals to Improve Public Health. This hearing focused on discussion of bills to reauthorize public health programs on:
      • Vector-borne diseases
      • Early interventions for cancer prevention
      • Environmental health
      • School health centers
      • Stem cell research
      • Access to therapies for ALS

•  Administration & Agencies:
  • CDC: President Trump has named Dr. Erica Schwartz as his nominee to lead the agency. She previously served as Deputy Surgeon General in his first Administration. Additionally, Sean Slovenski and Jennifer Shuford, were named as the nominees for the CDC’s Deputy Director and Chief Medical Office positions, respectively.
  • CMS: The agency has proposed a rule intended to narrow the number of breakthrough technologies eligible for supplemental Medicare payments via the New Technology Add-On Payment (NTAP). The guidance indicates that eligible technology must be both new and offer a substantial clinical improvement over available platforms. Additionally, the rule indicates a future repeal of pass-through payments for technologies used in outpatient settings.
  • FDA: The agency will convene an expert committee in July to discuss reclassification restricted peptides, which may allow them be compounded.
  • White House: The Administration has issued an Executive Order to expand access to psychedelics to treat mental illness. The order calls out ibogaine compounds that are currently being considered by the FDA. Among other measures, the order directs the FDA to provide Commissioner’s National Priority Vouchers (CNPV) to psychedelic drugs achieving breakthrough designation and ARPA-H to provide $50 M in matching funds to states who advance psychedelic research.

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 $612M and is eager to share our expertise to help companies grow and accelerate bringing innovations to patients.