Comment from Scott Strumello

My name is Scott Strumello, and I have lived with autoimmune Type 1 diabetes mellitus for the past 50 years. I was diagnosed as a 7 year old child. Over the past half-century, I have endured repeated insulin "retirements" whereby efficacious insulin products have been repeatedly and systematically withdrawn from the market (Iletin Semilente, Iletin Lente, Iletin Ultralente, Humulin Semilente, Humulin Lente, Humulin Ultralente, Novolin Semilente, Novolin Lente, Novolin Ultralente to name just a few; there are likely others I cannot recall from memory). The discontinuation of Novo Nordisk Levemir (insulin detemir injection, 100 units/mL) is merely the latest in a long stream of discontinuations, typically due to expiring Intellectual Property (IP) rights for these molecules. At least in the past, the excuse manufacturers gave was that the new products offered superior glycemic control, but when Levemir's discontinuation was announced, not one basal insulin could point to superior glycemic management as an advantage. And let's not forget: Insulin detemir remained a substantial product at the time of its withdrawal. According to the Medical Expenditure Panel Survey (MEPS) produced by the U.S. Agency for Healthcare Research and Quality (AHRQ) as of 2022 and derived from the ClinCalc DrugStats database, insulin detemir ranked as the 127th best-selling drug in the United States out of ~2,000 medicines approved by the FDA for sale, with more than 4.8 million prescriptions dispensed to over 900,000 patients. In addition, according to healthcare consulting firm Close Concerns, insulin detemir generated nearly $650 million in U.S. revenue during that same year. These figures demonstrate that insulin detemir remained an actively utilized therapy serving a substantial patient population and was not merely a legacy product approaching clinical obsolescence. And let me remind FDA: we were promised that the advent of legislation enabling biosimilars would render these product discontinuations moot because other manufacturers could step in to make them with the expiry of IP rights. Instead, we are seeing like 11 different glargine products from multiple manufacturers, and not one detemir biosimilar. On November 8, 2023, Novo Nordisk announced the planned discontinuation of Levemir in the U.S. The withdrawal was not the result of a newly identified safety concern or regulatory action. Rather, it reflected commercial and strategic considerations prevailing at the time the unilateral corporate decision was made, specifically the company's inability to meet demand for its obesity drugs (which are not World Health Organization designated "essential medicines" as insulin detemir is). While FDA likes to claim it is powerless to control the actions of commercial entities, in reality, FDA played a role. For example, following the signing of the Biologics Price Competition and Innovation Act (BPCIA) into law, FDA waited for nearly a decade to implemented needed policy changes to enable insulin products to be regulated as the biologic they were, and that excessive delay (the maximum amount of time allowable under the law) played a role by introducing uncertainty for biosimilar manufacturers of any insulin products, and delaying approval decisions (blaming COVID-19 shutdowns instead of FDA's own negligence in necessary policy implementation). There is plenty of blame to be assigned, and FDA rightfully shares in the situation patients now find ourselves in.