Comment from Alwin Emanuel

Re: April 30, 2026 FDA proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list. I respectfully challenge the conclusion that there is no clinical need for outsourcing facilities to compound GLP-1 receptor agonists, particularly as it relates to the FDA’s interpretation of “availability” in real-world patient care. I was prescribed a GLP-1 therapy when I weighed 284 pounds and had hypertension, along with laboratory indicators of prediabetes. Despite clear clinical risk factors and medical necessity, my insurance denied coverage because the medication was categorized as a weight loss treatment and I was not yet diabetic. As a result, I did not have meaningful access to the FDA-approved product through traditional channels. Compounded medication provided a pathway to treatment that would not have otherwise been available to me. Over the past 19 months, I have lost approximately 100 pounds and significantly improved my overall health. This intervention likely prevented progression to type 2 diabetes and reduced long-term cardiovascular risk. This outcome was achieved through consistent, patient-specific dosing tailored to my response. The FDA’s proposal relies on the premise that FDA-approved products are commercially available. However, from a patient care perspective, availability does not equate to accessibility. Insurance exclusions, cost barriers, and administrative restrictions create a substantial gap between theoretical availability and actual patient access. For patients in situations like mine, compounded GLP-1 medications are not a convenience or substitute—they are the only viable pathway to care. Without that access, it is unlikely I would have achieved the same clinical outcome. I encourage the FDA to adopt a more practical and patient-centered interpretation of “clinical need” that incorporates real-world access, continuity of care, and the ability of patients to obtain and adhere to prescribed treatment. At minimum, I urge the agency to consider limited pathways or exceptions for patients who are unable to access FDA-approved therapies despite clear medical indication. Thank you for the opportunity to provide input on this matter.