Comment from Achref Gouader

I'm writing as a patient whose daily survival depends entirely on Levemir (insulin detemir). I'm urgently requesting that the FDA designate Levemir as a drug in shortage so alternative manufacturing can begin immediately. There's a real human cost to taking this molecule off the market. For years, I fought a war inside my own biology every single night, paralyzed by the fear of severe nocturnal hypoglycemia. Levemir ended that volatility and gave me my baseline stability back. Physiologically, Levemir isn't just an interchangeable commodity that can be seamlessly swap for other basal insulins. My biology relies specifically on detemir's unique pharmacokinetic profile. Because it uses a 14-carbon myristic acid chain to bind reversibly to albumin, it gives a uniquely smooth, predictable, and linear buffering effect. When I'm forced to look at alternatives, I'm staring at a dangerous downgrade in care. Degludec (Tresiba) forms massive subcutaneous multi-hexamers with a long half-life. For a patient who needs tight metabolic control, this causes unpredictable stacking and completely strips away my ability to safely titrate doses in real time. Glargine (Lantus) relies on localized pH shifts to precipitate into microcrystals, making its absorption erratic and highly dependent on local tissue variables. Forcing metabolically stable patients off Levemir pushes us backward into an era of high-variance, unpredictable care. It's inevitably going to lead to a surge in ER visits and severe hypoglycemic trauma for those of us who just can't replicate our stability on alternative molecules. The demand for insulin detemir is absolute, and its absence will cause measurable harm. I respectfully urge the agency to execute its mandate to protect public health and designate Levemir as a drug in shortage today.