Comment from Anonymous

I write in strong opposition to the FDA's April 30, 2026 proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B Bulk Drug Substances List. While I understand the agency's mandate to protect public safety, this proposal — if finalized — will cause serious, measurable harm to millions of Americans managing obesity, type 2 diabetes, and related metabolic conditions. Access and affordability constitute a clinical crisis — not merely a "different problem." The FDA has explicitly stated that patient affordability is not a "clinical need" under its 503B framework. But this reasoning is dangerously narrow. When branded GLP-1 medications cost $900–$1,300 per month without insurance, and when coverage remains inconsistent across commercial plans and excluded from many Medicaid programs, the inability to afford a medication is, functionally, the same as that medication not existing. Declaring a shortage "resolved" while tens of millions of patients cannot access the commercially available product ignores the reality on the ground. For these patients, compounded alternatives were not a workaround — they were the only viable pathway to treatment. The obesity epidemic demands scale, not restriction. Obesity affects more than 40% of American adults and is a root driver of heart disease, stroke, sleep apnea, certain cancers, and type 2 diabetes. GLP-1 receptor agonists represent the most significant therapeutic advance in metabolic medicine in a generation. Restricting the production pathways for these medications at this moment — when clinical demand is exploding and commercial supply remains constrained for many patients — runs counter to the public health imperative. Compounded medications filled a real and ongoing gap. Compounded GLP-1 medications reached roughly 30% of the U.S. supply at peak in 2024, serving patients who had no other option. The suggestion that the market has "stabilized" overlooks persistent access disparities across income levels, geography, and insurance status. Rural patients, uninsured patients, and those on high-deductible plans have relied on compounding pharmacies and telehealth platforms as the primary conduit to these medications. Eliminating large-scale compounding will not redirect these patients to brand-name products — it will simply leave them without treatment. The FDA's own clinical-need standard should be revisited. The FDA has stated it has not identified a basis to conclude that the approved routes of administration are medically unsuitable for certain patients. But clinical need should encompass not only route-of-administration differences, but also dose flexibility, access equity, and real-world affordability. A rigid reading of "clinical need" that ignores socioeconomic barriers to access does not reflect the full scope of patient welfare that the agency is charged with protecting. Safety concerns can be addressed through regulation, not prohibition. I acknowledge that adverse event reports tied to compounded GLP-1s are a legitimate concern. The FDA received more than 455 adverse event reports linked to compounded semaglutide and more than 320 reports associated with compounded tirzepatide by early 2025, many involving dosing errors from multidose vials. However, these safety issues point to the need for stronger compounding standards, clearer labeling requirements, and better patient education — not outright prohibition of large-scale compounding. Banning an entire production pathway because of dosing errors attributable to insufficient oversight is disproportionate and forecloses better-targeted solutions. Request: I urge the FDA to: Reconsider the exclusion of these medications from the 503B Bulks List and adopt a broader, more equitable definition of "clinical need" that accounts for access barriers. Pursue enhanced safety standards for 503B compounders of GLP-1 medications rather than eliminating the compounding pathway. Coordinate with Congress and CMS to address the underlying affordability crisis that makes compounded alternatives medically necessary for millions of patients. Extend the public comment period to allow broader patient and provider input given the magnitude of this decision. The FDA was right to address the surge of unregulated compounding that accompanied the shortage period. But the answer to a regulatory gap is not to shut the door on access — it is to build a safer, better-regulated framework that serves patients across the income spectrum. I urge the agency to choose the path that protects both safety and access.