The U.S. Senate is navigating a dense legislative landscape as it approaches its summer recess. With a focus on appropriationsfederal funding and advancing nominations the Senate is poised to make significant strides before adjourning. Among the key actions is the release of a continuing resolution (CR) on August 2, 2026, by Senate Committee on Appropriations Chair Susan Collins (R-Maine) and Ranking Member Patty Murray (D-Wash.).
This CR aims to fund the federal government through December 11, 2026, extending the House’s CR, which funds the government through December 4, 2026. Notably, the Senate’s CR includes a provision to delay the Office of Management and Budget (OMB) from proceeding with a proposed rule that would significantly alter the review and distribution of federal grant funding.
Upcoming Elections and Congressional Events
August 4, 2026, marks a significant day for primary elections, featuring contests for the Senate in Michigan, gubernatorial races in Kansas and Tennessee, and House seat selections in several other states. These elections are crucial as they set the stage for the upcoming legislative sessions.
The Senate has a busy schedule ahead, with several key committees holding important meetings. The Senate Committee on the Budget will discuss Medicaid: The Reality while the Senate Committee on Finance will explore Building a Resilient Health Care Future with Biotechnology. Additionally, the Senate Committee on the Judiciary will delve into Prescribing Sunshine: How Competition and Transparency Lowers Prescription Drug Costs.
Federal Agencies and Regulatory Updates
The U.S. Food and Drug Administration (FDA) is set to hold a hybrid public meeting on September 23-24, 2026, titled FDA-CRGC Workshop – Navigating the GLP-1 Generic Drug Pathway. This meeting is part of the FDA’s ongoing efforts to streamline the approval process for generic drugs.
The Healthcare Advisory Committee (HAC) has announced its virtual meeting schedule for the remainder of 2026 through. These meetings, scheduled for August 31, 2026, November 9, 2026, February 22, and May 10, will address critical healthcare advisory issues.
Administrative and Executive Order Updates
Holland & Knight’s Health AI Navigator serves as a centralized resource for tracking the evolving legal and regulatory landscape for artificial intelligence (AI) in healthcare. It provides summaries of federal and state legislative, regulatory, and executive activity, including developments from the U.S. Congress, the U.S. Department of Health and Human Services (HHS), and the White House.
The Trump Administration has continued to release wide-ranging executive orders (EOs). For the latest updates, refer to the tracking chart titled Trump’s Second-Term Executive Orders (2026-2026).
Personnel and Congressional Updates
The Senate Committee on Health, Education, Labor, and Pensions (HELP) has advanced the nominations of Dr. Erica Schwartz to be director of the Centers for Disease Control and Prevention (CDC), Sean Schwartz to be assistant secretary for preparedness and response, and Keith Sonderling to be secretary of the U.S. Department of Labor (DOL).
House Committee on Oversight and Government Reform Ranking Member Robert Garcia (D-Calif.) has sought answers regarding the outbreak of Cyclospora infections linked to certain lettuce products. The letter requests details on the company’s outreach to the White House and federal agencies, as well as any political considerations that may have influenced decisions.
Senate Committee on Finance Ranking Member Ron Wyden (D-Ore.) has issued a request for information (RFI) seeking feedback from stakeholders regarding health coverage and potential areas for reform. The RFI outlines the committee’s focuses for the new Congress, including reversing policies advanced by congressional Republicans, simplifying healthcare options, and implementing reforms to private insurance.
Regulatory Updates: HHS and CMS
The Department of Health and Human Services (HHS) has announced a new federal government-wide policy to prohibit federally funded or supported gain of function research. This policy follows concerns stemming from the COVID-19 pandemic and aims to improve the safety and security of biological research.
The HHS Administration for Children and Families (ACF) has issued a final rule to amend regulations governing grants to states for public assistance programs. This rule takes effect on September 29, 2026, and makes changes to the administration, funding, accountability, and oversight of the Temporary Assistance for Needy Families (TANF) program.
The Centers for Medicare & Medicaid Services (CMS) has issued several final payment rules, including updates to the Skilled Nursing Facilities (SNFs) Prospective Payment System (PPS) and Inpatient Psychiatric Facility (IPF) PPS for fiscal year (FY). These rules finalize updated payment rates and remove certain measures from quality reporting programs.
Regulatory Updates: FDA and HRSA
The FDA has implemented a reorganization to consolidate certain staff and terminate specialized inspections staffing. This Simple Reform is set to take effect starting October 1, 2026, and will impact the FDA’s field inspectors and the Office of Applied Science within the Center for Veterinary Medicine.
The FDA has also issued revised draft guidance on the design of bioequivalence studies to support abbreviated new drug applications (ANDAs). Additionally, the FDA has published user fee rates and payment procedures for various programs in FY.
The Health Resources and Services Administration (HRSA) has released a notice outlining the new 340B Rebate Model Pilot Program. Manufacturers may apply to participate, with responses due August 24, 2026, to take effect January 1.
Other Healthcare Regulatory Updates
The National Security Commission on Emerging Biotechnology (NSCEB) has issued a report titled Bringing Rare Disease Treatments to Patients. This report addresses barriers to therapeutic development of treatments for rare diseases and outlines areas for Congress to consider action on, including enhanced investments in research and development, data collection, and regulation of novel biotechnologies.
