ASGCT's NIH Indirect Funding Sign-On Letter

March 4, 2025 

Dear Chair Collins, Vice Chair Murray, Chair Cole, and Ranking Member DeLauro, 

On behalf of the undersigned organizations, we ask you to ensure robust appropriations for NIH in the remainder of fiscal year (FY) 2025 and for FY 2026. We further urge Congress to reaffirm the current statutory arrangement for Facilities & Administrative (F&A or “indirect”) cost reimbursements. ¹ U.S. Congress (2024). Further Consolidated Appropriations Act [H.R.2882]. https://www.congress.gov/118/plaws/publ47/PLAW-118publ47.pdf   NIH funding is an integral part of the United States research enterprise, which leads the world in innovative research and development for transformative medicines and rare disease treatments. Our organizations believe cuts to the overall NIH budget or caps on F&A would significantly slow scientific advancement and ultimately cause harm to patients. 

NIH funding has supported an untold number of breakthroughs for patients, providing hope for those facing both rare and common diseases. These biomedical advances can offer improved quality of life or, in some cases, an effective cure for devastating illnesses. Cell and gene therapies (CGTs) have revolutionized treatment options for a wide range of diseases. CGTs have changed the treatment paradigm for certain blood cancers for pediatric and adult patients, can cure genetic diseases such as sickle cell anemia and spinal muscular atrophy, and are forging pathways for new therapies to treat, and potentially cure, patients with serious diseases such as lupus and Huntington’s Disease, among hundreds more. 

While there is a strong therapeutic pipeline, ² ASGCT and Citeline (2024). Gene, Cell, & RNA Therapy Landscape: Q4 2024 Quarterly Data report. https://www.asgct.org/global/documents/asgct-citeline-q4-2024-report.aspx   continued investments in basic, translational, and early clinical research are needed to build on deep scientific underpinnings. A critical component of NIH funding is F&A reimbursements to support research. These are funds provided to an institution when a scientist receives a grant. They are neither supplemental nor insignificant. Rather, they are integral to CGT research and support critical functions including: 

Manufacturing and Materials 

• Institutions establish complex patient cells and vector production facilities that can be utilized across multiple research groups. While some project-specific machinery may be paid for with grant funding, costs of other shared equipment such as bioreactors or incubators, centrifuges, chromatography systems, and cryopreservation storage are shouldered by the institutions and supported through F&A. F&A funds also support the biomedical engineering staff who install, calibrate, maintain, and repair those apparatuses.
• Specialized disposal services are required for biological, chemical, or radioactive waste products created in the course of research.

Research Outputs 

• Research design and compliance programs oversee informed consent and monitor patient safety in clinical trials. Principal Investigators (PIs) may run multiple clinical trials simultaneously; therefore, they rely on specialized teams at their institutions to help streamline processes. This allows PIs to maximize the clinical trials performed and the number of patients who can safely enroll in any given trial. 
• Staff experts help ensure promising research can advance beyond the lab to patients’ bedside. 
• Access to advanced data systems which play a keystone role in CGT research, including cloud-based data management, high performance on-site computing resources, and specialized image rendering software. 

This short list represents a sample of the ways in which F&A funds support research. If F&A cuts are enacted, institutional efficiency and the speed of scientific advancement will be severely curtailed. 

The undersigned organizations represent the scientists, physicians, patient advocates, and other professionals developing, and committed to the advancement of, CGTs across the United States. US institutions perform critical work to advance the underlying research that has led to today’s robust pipeline of transformative therapies. From the bench to the bedside, this work has improved the lives of patients – but ongoing, stable investment is necessary to continue that positive trajectory. 

For these reasons, we again urge Congress to protect robust NIH appropriations in FY 2025 and FY 2026 and prevent sudden and significant changes to Facilities & Administrative costs. Thank you for your leadership to ensure continued investment in this research to save and improve lives. 

If you have questions, please do not hesitate to contact Margarita Valdez Martínez, Chief Advocacy Officer at the American Society of Gene & Cell Therapy (ASGCT) at mvaldez@asgct.org. 

Sincerely, 

American Society of Gene & Cell Therapy 

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