Comment from Wagner Amber

To whom it may concern, I'm writing you today regarding the decision to exclude tirzepatide, semaglutide, and liraglutide from the list of bulk substances for which there is a clinical need under section 503B. Not only do these pharmacies provide patients with life saving medications, but they also provide patients with custom, flexible dosing regimens, and availability in medication desserts. These custom medications are often modified to include vitamins and aminos that a patient is deficient in. For example, I have pernicious anemia, and my medication contains b12 for my deficiency. These custom medications have the added benefit of improving cardiovascular outcomes, nutritional deficiencies, diabetes, metabolic disorders, addiction, glycemic control, cholesterol, lipid profiles, weight, and insulin resistance. These medications, and their dosages, are often modified specifically to meet the needs of patients and desired outcomes. Further, production under 503B was not an issue when Eli Lilly and Novo Nordisk prevailed upon the industry to enter production to help the medication shortage. A shortage that still exists in small communities, and will only get worse without the availability of 503B production. Availability of brand name medications is often limited and unavailable. Further, our struggling healthcare system is virtually non-existent to many patients. Whether that is due to cost, limitations of insurance, the defunding of the ACA, the rise in insurance costs, the overwhelmed and under funded medical facilities, or any of the other issues that plague our system and prevent basic healthcare access to average individuals. Access to these medications is often the only option for any form of healthcare in this broken system. Insurance refuses to cover these medications, forcing patients to pay out of pocket. Access and affordability should not be restricted until every American can access healthcare and insurance coverage that covers this medication. Health outcomes, medication access, and affordability should not be limited to the wealthy. Essentially, the FDA is asking the the public to ignore that these drugs were researched and funded by the public. We subsidized the research, studies, and their shareholder interests. But the FDA is suggesting that the public doesn't deserve access to these medications, or better health outcomes, unless we can further subsidize corporate greed. We are not being offered a better healthcare system. We are not being offered a better insurance system (in fact the complete opposite with this administration's choice to defund the ACA). We are being told that despite public funding for these institutions, as well as the public funding that subsidized the pharmaceutical companies, that we will not have access to our only lifeline to health. I beg you to reconsider 503B pharmacies, and to understand their necessity to public health. Millions of people require access to these life saving medications. They do not deserve to be deserted. Our citizens deserve better access to better health. Thank you for your consideration.