Comment from chaney steve

I strongly oppose the FDA’s proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list. For millions of Americans, these medications are not elective—they are essential. GLP‑1 therapies are clinically proven to treat obesity and type 2 diabetes, two conditions that drive cardiovascular disease, disability, and premature death. The science is clear. The barrier is access. Today, access is failing patients. Brand-name GLP‑1 medications frequently exceed $1,000 per month. Insurance coverage is inconsistent and often excludes obesity treatment altogether. As a result, many patients who meet medical criteria are effectively locked out of care—not because the therapy doesn’t exist, but because they cannot afford it. 503B compounding pharmacies have been a critical bridge, particularly during and after shortages. They have enabled patients to start—and stay on—life-changing therapy when commercial channels fall short. Eliminating these medications from the 503B bulks list will not resolve a safety issue—it will create a public health access crisis. The designation of “no longer in shortage” does not reflect real-world availability. A medication that is financially out of reach is, in practical terms, unavailable. Removing compounded alternatives will force patients to discontinue treatment, delay care, or abandon it altogether. The consequences will be immediate and measurable: Worsening glycemic control Increased obesity-related complications Higher rates of hospitalization Greater long-term healthcare costs Safety is critical—but it is not mutually exclusive with access. It can and should be addressed through strengthened oversight, enforcement, and quality standards for 503B facilities. A blanket exclusion is neither targeted nor balanced. Until branded GLP‑1 therapies are consistently affordable and broadly covered by insurance, compounded options remain indispensable. This decision must put patients first—not theoretical supply status or market dynamics. Do not remove these medications from the 503B bulks list. Doing so will deny access to effective treatment and harm the very patients the healthcare system is meant to serve.