By Patrick Cooney, for AMRC
FEDERAL AGENCY NEWS
CDC Challenges May Impact Researchers
The Centers for Disease Control and Prevention (CDC), long regarded as the nation’s premier public health agency, is undergoing unprecedented challenges. In addition to sweeping layoffs and the elimination of long-standing programs, its director, Dr. Susan Monarez, was recently dismissed under contested legal circumstances. For AMRC members, this changing landscape affects everything from data access to research partnerships.
In July 2025, Dr. Monarez became the first CDC director confirmed by the Senate. Less than a month later, she was dismissed under contested legal circumstances. In her place, HHS Deputy Secretary Jim O’Neill was named acting director. This leadership shift triggered a wave of resignations from senior scientists, including the directors overseeing immunization, infectious diseases, and data surveillance. Walkouts and protests have further destabilized the agency.
Dr. Monarez is an American microbiologist and public health official. She earned her Ph.D. in microbiology and immunology from the University of Wisconsin–Madison in 2003, with a research focus on infectious diseases. She has held several key science-policy roles in the federal government at the Department of Homeland Security as Deputy Assistant Secretary for Strategy and Data Analytics, on the National Security Council guiding efforts on antimicrobial resistance and pandemic preparedness, and as founding director of the Center for Innovation at HRSA. Most recently, as Deputy Director of ARPA-H, she led initiatives on AI-driven health interventions, mental health, maternal health disparities, and more.
Less than a month in office at the CDC, on August 27, 2025, Monarez was removed as CDC Director. The White House cited misalignment with the “Make America Healthy Again” agenda as the rationale. However, reports indicate the firing was precipitated by Monarez’s refusal to approve directives from RFK Jr.’s handpicked vaccine advisory panel, which had replaced the longstanding Advisory Committee on Immunization Practices (ACIP).
Additionally, advisory structures such as the Advisory Committee on Immunization Practices (ACIP) have been disbanded. These changes create significant data gaps that could ripple into epidemiological research, trial design, and site-level decision making. AMRC members should anticipate the need to source alternative datasets and partnerships for studies that previously depended on CDC surveillance systems.
Congress has taken notice. The Senate Health Education Labor and Pensions Committee has begun reviewing the departures and restructuring. Nine former CDC directors have publicly warned that the agency’s credibility and scientific authority are being undermined. The Senate Finance Committee is holding a hearing this week where the dismissal will likely be raised.
NIH Extramural Loan Repayment Program: Application Cycle Open
On August 28, 2025, the NIH announced that the application period to apply for FY 2026 NIH Extramural Loan Repayment Program (LRP) awards will open on September 1, 2025 and close on November 20, 2025.
The Extramural LRP was established to recruit and retain highly qualified biomedical and behavioral researchers in the research workforce. The LRP offers up to $100,000 in qualified educational debt repayment in exchange for a two-year commitment to conduct research.
Eligibility: Applicants must be qualified health professionals engaged in NIH-mission relevant research for a minimum of 20 hours per week at a nonprofit or government institution. Mission-relevant research areas include:
- Clinical Research
- Pediatric Research
- Health Disparities Research
- Research in Emerging Areas Critical to Human Health (REACH)
- Clinical Research for Individuals from Disadvantaged Backgrounds
- Contraception and Infertility Research
The LRP provides unique opportunities and substantial benefits to early-stage researchers. Click HERE for more information.
FDA Launches Adverse Event Data Site
On August 22, 2025, the U.S. Food and Drug Administration began daily publication of adverse event data from the FDA Adverse Event Reporting System (FAERS).
FAERS is the FDA’s primary database for collecting and analyzing adverse event reports, serious medication errors, and product quality complaints for prescription drugs and therapeutic biologics, containing reports submitted by healthcare professionals, consumers, and manufacturers. The public can view the latest adverse event data on the FAERS Public Dashboard.
CAPITOL HILL NEWS
House Appropriations Committee to Act on FY26 Funding for Clinical Research
The House’s FY2026 Labor–HHS–Education appropriations bill sets HHS discretionary spending at $108 billion, a 6% cut from FY2025. While the topline reflects overall restraint, the bill preserves core biomedical research funding and makes selective investments in preparedness, program integrity, and workforce — all of which carry implications for multisite clinical research networks. As we reported a few weeks ago, the Senate Appropriations Committee largely rejected the proposed federal health spending cuts outlined by Secretary Kennedy and the Trump Administration. The Senate is unlikely to go along with the House version which sets up a possible continuing resolution to fund the government at FY25 levels for FY26.
NIH: Stability in Biomedical Research
The National Institutes of Health (NIH) is funded at $48 billion, effectively level with FY2025. Within that, the bill emphasizes:
- Office of the Director/Common Fund: $2.43B, supporting cross-cutting research priorities
- NCATS: $928M, including $75M for the Cures Acceleration Network, a key platform for translational science.
- Buildings & Facilities: $352M to modernize research infrastructure.
For AMRC members, this stability ensures continuity in research funding streams, collaborative grants, and infrastructure upgrades critical to sustaining multisite studies.
Preparedness and Supply Chain: Opportunities for Clinical Research
The Administration for Strategic Preparedness & Response (ASPR) receives $3.02B, including:
- BARDA: $1.95B for advanced R&D of medical countermeasures.
- Strategic National Stockpile: $1.03B, with restrictions on China-sourced products.
These investments open pathways for multisite research corporations to partner on clinical trials for vaccines, therapeutics, and devices, and to contribute to supply chain evaluations. BARDA’s translational mission aligns with AMRC’s strengths in rapid, multi-center trial execution.
Cuts That Affect the Research Ecosystem
The bill includes reductions that may ripple through the research community:
- CDC: Cut by 19%, consolidating 35 programs. While core infectious disease funding is maintained (e.g., Immunization $879M; Emerging Pathogens $777M), broader public-health research partnerships may contract.
- AHRQ: Eliminated entirely. This reduces federal leadership on patient safety research and health services evaluation — areas often integrated into multisite trials.
CMS and Evidence Development
- CMS Program Integrity: $941M supports stronger oversight of healthcare spending.
- While not direct research funding, CMS’s focus on accountability reinforces the importance of real-world evidence, outcomes studies, and post-market surveillance — all areas where multisite research collaborations are crucial.
Workforce and Access: Indirect Benefits
- HRSA Workforce Programs: $1.36B.
- Rural Health: $515M.
These investments bolster the clinical workforce and expand access to care, creating more diverse and sustainable research sites for multisite trials.
Clinical Trial Modernization Act
On May 20, 2025, Rep. Raul Ruiz (D-CA) introduced legislation that could reshape the clinical research landscape in ways highly relevant to multisite research corporations. The Clinical Trial Modernization Act (H.R.3521) aims to remove persistent barriers to patient participation in clinical trials while modernizing compliance rules for sponsors and sites.
The bill applies to “approved clinical trials” which is defined in existing law as meaning a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or condition. Some have said this definition should be more broad to encompass any clinical trial.
Grants to Support Enrollment and Diversity
The bill authorizes the Department of Health and Human Services to issue grants in FY2025–2026 for community outreach, education, and investigator training, with an emphasis on enrolling underrepresented populations in clinical trials.
Safe Harbors for Patient Support
H.R. 3521 creates explicit protections under the Civil Monetary Penalties and Anti-Kickback statutes so that trial sponsors may reimburse participants for non-cost-sharing expenses such as travel, transportation, and meals. It would allow providing digital health technologies (e.g., tablets, wearables) to underrepresented participants to facilitate remote participation.
Covering Patient Cost-Sharing
Sponsors may pay trial participants’ copayments and coinsurance without fear of violating fraud and abuse laws—if strict safeguards are met. These include requirements that support be applied uniformly, not contingent on future product use, and capped at participants’ actual cost-sharing amounts. Oversight by Institutional Review Boards (IRBs) and adherence to federal coverage rules are mandatory.
Tax Relief for Participants
A new section of the Internal Revenue Code would exclude up to $2,000 annually from taxable income for payments that participants receive for approved clinical trials. This provision is designed to prevent surprise tax bills that could discourage trial participation.
The bill has garnered endorsements from over 100 patient advocacy groups and professional associations, including the American Cancer Society Cancer Action Network, the National Health Council, the National Alliance on Mental Illness, and the Association of Black Cardiologists. This momentum underscores the urgency of addressing financial and logistical barriers that keep too many patients from accessing cutting-edge trials.
