G2G Bio Bulletin – February 14, 2026

FY 2027: Republican House Appropriations leaders may allow earmarks back into the FY 2027 Labor-HHS-Education (LHHS) appropriations bill that funds most health agencies. These one-time awards to non-profit entities have not been included as line items in the House versions of the LHHS bill since Republicans took control of the chamber in 2023. If this proposal moves forward, there will be significant restrictions on eligible projects, and the overall allocation for earmarks will still not exceed 1% of discretionary spending across all appropriations bills. Senators, meanwhile, have been barred from requesting LHHS earmarks over the past few years.

FY 2026: The Department of Homeland Security (DHS) is in a shutdown, as lawmakers failed this week to come to an agreement on changes to immigration enforcement policy to accompany the agency's appropriations bill. Meanwhile, all other federal agencies are fully funded through September, and grantmaking entities have begun to post new funding opportunities.

Lack of transparency across the medical supply chain and their impacts on drug prices

The role of vertical integration in driving up drug costs, and recently passed and potential future PBM reforms

Federal pricing regimes including those through the 340B program, the IRA and deals made by the Trump Administration

Balancing the need to support development of innovative therapies, while also maintaining affordability for patients

Senators Josh Hawley (R-MO) and Elizabeth Warren (D-MA) introduced the Break Up Big Medicine Act, which prohibits certain practices that lead to vertical integration of the healthcare system, and is paired with penalties and expanded regulatory authorities to address violations.

Representatives Jack Bergman (R-MI) and Jake Auchincloss (D-MA) introduced the Community Health Center Drug Pricing Protection Act, which seeks to exempt Community Health Centers (CHCs) and Federally Qualified Health Centers (FQHCs) from higher upfront drug prices under a potential shift to a rebate model for the 340B drug pricing program.

The agency has refused to review Moderna’s application for a new mRNA flu vaccine, with the rationale that the candidate product was not compared to the “best-available standard of care.” Moderna contested the claim noting that prior communications with agency, indicated that the their study parameters were appropriate. CBER Director Vinay Prasad, overruled career staff who recommended that application be reviewed and also personally signed the refusal to file letter, which is not standard protocol. The company still has the opportunity to file the application “over protest".

The agency has rejected an application for a drug that was included the first cohort of the CNPV program which has promised faster review times for products aligned with key national health priorities.

HHS Leadership & Personnel Changes: The HHS Deputy Secretary and acting CDC Director Jim O’Neill, is leaving his position, as is HHS General Counsel Mike Stuart. Chris Klomp, Director of the Center for Medicare, will assume the new position of HHS Chief Counsellor, with responsibility overseeing operations across the department. A handful of other HHS appointees were promoted to new roles by HHS Secretary Kennedy earlier this week.

340B Program: HHS has filed a request for information (RFI) in an effort to go back to the drawing board on potentially shifting 340B to a rebate model, after implementation of the initial rebate pilot stalled amid litigation. The RFI seeks comment from stakeholders on logistical, financial and access concerns with a rebate model. The comment submission deadline is March 19.

Grants: HHS will be cutting $600M in public health infrastructure grants to California, Minnesota, Illinois and Colorado, with rationale being those states’ lack of alignment with Administration priorities. This action comes almost a month after HHS paused and then unpaused $5 billion in wider public health supports.

Vaccine Policy: Arguments were presented in federal court this week, as part of the lawsuit filed by the American Academy of Pediatrics (AAP) against HHS on changes made to the Advisory Committee on Immunization Practices (ACIP).

Affordable Care Act (ACA): HHS announced a proposed rule that among other provisions, would allow more types of healthcare plans to quality for inclusion on ACA exchanges under minimum essential coverage standards, multi-year catastrophic healthcare plans and more expansive hardship exemptions.