G2G Bio Bulletin – June 22, 2026
Updates from Washington
Congress:
- FY 2027 Appropriations: The House was on recess this past week. Senate Appropriations Committee Chair Susan Collins (R-ME) has scheduled markup of the chamber's version of the Ag-FDA, Milcon-VA, Commerce Justice Science & Legislative Branch bills for Thursday.
- Drug Pricing: Democrats on the Senate Finance Committee, led by Ranking Member Ron Wyden (D-OR) have released a request for information (RFI) comment from stakeholders on a suite of policy proposals aimed at addressing rising drug costs. Comments are due August 17. The RFI has three pillars, Lowering Drug Prices, Enhancing Prescription Drug Affordability and Bolstering Biopharmaceutical Innovation. Key provisions under these pillars include:
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Increasing the number of drugs whose price HHS can negotiate per year under IRA provisions, and allowing the negotiation to begin earlier in product lifecycles.
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Establishing a subscription model to broaden access to and lower prices for widely used medicines like GLP-1s.
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New caps on out-of-pocket spending on essential medicines for chronic diseases, to build upon ongoing initiatives with insulin.
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Increasing oversight of pharmacy benefit managers (PBMs), in pricing and contracting.
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Cracking down on vertical integration.
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Incentives for academia and the private sector to expand basic and translational research on drugs, with a focus on addressing unmet needs and supporting smaller biotech companies.
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- Healthcare Legislation: The Senate Health Education Labor & Pensions (HELP) Committee on Wednesday convened a hearing to markup several bipartisan bills. Highlights are as follows:
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Committee Ranking Member Sen. Bernie Sanders (I-VT) attempted to add several amendments to one of the bills under consideration, the Ensuring Timely Access to Generics Act, which would clamp down on pharmaceutical companies’ practice of using the FDA citizen petition process to delay approval of generics. Sen. Sanders was successful in advancing one amendment, to cap insulin costs at $35, which mirrors the objectives of the INSULIN Act. Full committee consideration of the bill was subsequently postponed.
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The committee unanimously passed bills to reauthorize programs on stem cell research, breast cancer education, ALS research, and reducing infant mortality and improving maternal health outcomes.
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The committee unanimously passed bills to codify interchangeability for all biosimilars with their name-brand counterparts, bolster drugmakers’ reporting requirements to close loopholes used to extend patent protections and prohibit discrimination in access to organ transplants on the basis of disability.
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- Biological Data Resource Legislation: On Tuesday, a National Security Commission on Emerging Biotechnology (NSCEB) recommendation was introduced as the Web of Biological Data Act by Rep. Matt Van Epps (R-TN), Rep. Jake Auchincloss (D-MA), Sen. Todd Young (R-IN), Sen. Alex Padilla (D-CA), Sen. Mike Rounds (R-SD) and Sen. Andy Kim (D-NJ).The legislation seeks to designate high quality biological data as a strategic asset, by directing the Department of Energy to establish a centralized hub for such data, which would serve as a single access point and allow for training of AI models to advance new research.
- National Defense Authorization Act (NDAA): The Senate Armed Services Committee by a vote of 18-9, has passed its version of the FY 2027 NDAA to authorize $1.15 T in military spending. Like the corresponding House legislation, it contains provisions on biotechnology supported by NSCEB such as on use of AI for biosecurity and procurement screening and prohibiting military contractors from providing adversarial nations with sensitive synthetic biology data.
- Vaccine Data: Sen. Wyden and Sen. Maggie Hassan (D-NH) have written to HHS Secretary Kennedy, demanding that he release documentation surrounding the significant changes in vaccine policy during his tenure, by July 17.
Administration & Agencies:
- CMS: The agency has published an RFI that would guide how it implements PBM reforms enacted by Congress last year. Responses are due July 20.
- NIH:
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The agency announced the formation of the Office of Research Innovation, Validation, and Application (ORIVA) to coordinate efforts to to develop, validate and scale New Approach Methodologies (NAMs) including 3D human tissue models, computational tools and other animal-free methods.
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The agency has published an RFI to gather information from stakeholders in defining specific, measurable indicators and incentives that reflect the collaborative, rigorous, and mission-driven nature of modern biomedical science. Responses are due August 19.
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- FDA:
- The agency has approved a plan proposed by Colorado to import certain prescription medicines from Canada to the state. This proposal is authorized under the FDA’s Section 804 Importation Program (SIP), which permits state and tribal governments to purchase Canadian medicines to bring down prices.
- Citing new clinical data, agency announced that manufacturers of testosterone replacement therapy products should remove warning labels cautioning of insufficient evidence of their safety and efficacy.
- The Vaccines and Related Biological Products Advisory Committee recommended that the FDA approve Moderna’s mRNA flu shot for older adults, several months after the agency attempted to decline review of the vaccine.
- White House, Other HHS Agencies & Departments
- Secretary Kennedy on Thursday announced $700 M in funding for mental health, most of which will be through existing programs at the Substance Abuse and Mental Health Administration (SAMHSA)
- Drug Prices: The Office of the Trade Representative has opened an investigation on Germany alleging that country’s underpayment for pharmaceuticals has contributed to elevated prices for those products in the US.
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.