Text SIGN PFFGSH to 50409 — The NIH estimates that about 26 million Americans have an autoimmune disease, and growing evidence shows that microbiome disruption plays a significant role in these conditions as well as in other chronic inflammatory disorders. Because the microbiome plays a central role in immune stability, disruptions in microbial health contribute directly to long-term disability. These conditions keep many Americans from participating in our society and our economy. Chronic illness imposes heavy costs on families, on health-care systems, and on the country’s overall capacity. One intervention shows meaningful potential to restore daily functioning, yet it remains unavailable to most people who could benefit. People with chronic conditions often seek fecal microbiota transplantation (FMT) when conventional options do not resolve their symptoms. In real-world use, some individuals experience meaningful recovery, including restored digestion, improved stability, and a return to daily routines. Others experience complications and, rarely, severe outcomes. We learn almost nothing from these outcomes because nearly all real-world FMT use in the United States takes place outside supervised medical care. DIY-FMT is widespread, with evidence that tens of thousands of people do it. These outcomes scale to national cost. Preventable injuries occur without standardized screening and oversight. Valuable real-world information is lost because it is never recorded. National resilience and economic strength decline when chronic illness remains unnecessarily entrenched. Congress can address this structural problem by directing the FDA to establish a supervised clinical pathway for FMT. That pathway should rely on donor screening, medical oversight, and basic outcome tracking. A modernized approach would reduce harm, support recovery, and generate real-world data that strengthens public health. This update would improve individual well-being and support the country’s overall capacity. A supervised pathway would serve both patients and the country.

Text SIGN PTRSAP to 50409 — The current classification of fecal microbiota transplantation (FMT) as a drug is causing public harm. I’m asking you to use congressional oversight to ensure the FDA updates its regulatory approach to FMT. It needs to align with the frameworks used for other biological materials. FMT is not a drug; it is a living microbial community and these communities can be used safely to repair many health conditions including ulcerative colitis, irritable bowel syndrome, hepatic encephalopathy, and several microbiome-driven disorders. Safety depends on donor quality and screening, not chemical manufacturing processes. Today, the FDA treats FMT as an unapproved drug and requires drug-manufacturing standards that do not fit the biology of this therapy. High-quality, well-screened donors are blocked, while unsafe or informal routes remain available. Clinicians can’t use safe sources even when they want to supervise care, and clinical development is held back because drug-manufacturing rules are incompatible with donor-based therapies. Congress has stepped in before when a biological material didn’t fit drug rules, creating tailored frameworks for tissues, blood, and human cellular products. FMT fits this same pattern. The FDA needs an FMT-specific pathway that focuses on donor standards, clinician oversight, and appropriate safety tracking, without imposing drug requirements that don’t improve outcomes. I’m asking you to direct the FDA to establish a dedicated regulatory category for FMT that aligns oversight with biology. This would center regulation on donor quality, medical supervision, and outcome tracking, while removing drug-manufacturing requirements that do not fit. A straightforward update in classification can reduce harm, improve safety, and open a path for appropriate clinical use. Thank you for your attention to this needed modernization.

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