Comment from Smith Cassandra

I strongly oppose the FDA’s proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list. For many Americans, these medications are not optional. They are life-changing treatments for obesity and type 2 diabetes—conditions that drive heart disease, disability, and early death. The clinical value of GLP-1 therapies is clear. The problem is access. Right now, access is broken. Brand-name GLP-1 medications often cost over $1,000 per month. Insurance coverage is inconsistent or nonexistent, especially for obesity treatment. Many patients who medically qualify for these drugs simply cannot afford them. 503B compounding pharmacies have stepped in to fill that gap—especially during and after recent shortages—offering more affordable options that allow patients to actually start and continue treatment. Removing these medications from the 503B bulks list will not solve a safety crisis. It will create an access crisis. Ending formal “shortage” status does not mean these drugs are truly available to patients. If people cannot afford a medication, it is effectively unavailable to them. Eliminating compounded options will force patients to stop treatment, go without care, or never begin at all. That has real consequences: worsening diabetes, increased obesity-related complications, and higher long-term healthcare costs. Safety matters—but it can be addressed through oversight, enforcement, and quality standards for 503B facilities. A blanket exclusion is not a balanced solution. Until brand-name GLP-1 medications are broadly affordable and consistently covered by insurance, compounded alternatives remain essential. This decision should prioritize patients—not just supply metrics or market protection. Do not remove these medications from the 503B bulks list. Doing so will take effective treatment out of reach for the very people who need it most.