Comment on FR Doc # 2026-10128

I would like to start off my thanking the DEA very much for their efforts on controlling the Drug epidemic and continued efforts in mitigating the ADHD medication shortage. I have some highly concerning issues to bring write about, in regards to ADHD medications, and how I believe the DEA can help significantly. As the ADHD medication shortages rage on, quality differences between the generic manufacturers of ADHD medications have become glaringly obvious to patients, doctors and pharmacists alike. The following study by yale school of medicine found that half of the generic methylphenidate ER formulations tested released active ingredients at a different rate from their corresponding brands. [1] https://www.psychiatryadvisor.com/news/generic-methylphenidate-drugs-have-significant-quality-concerns/ While the region of quality control falls squarely under the FDAs jurisdiction, there are many real-world variables the DEA controls, such as changes to the quota system, that will significantly help ameliorate the ADHD medication shortage and quality crisis. A significant number of ADHD patients are highly sensitive to differences between specific manufacturers of ADHD medications. The shortages have made it incredibly difficult to access preferred generics, and many patients, including myself are experiencing subpar therapeutic results, and exorbitant side effects from generic ADHD medications. Like myself, many patients have had their providers drastically and suddenly dose increases to compensate for sub-therapeutic effects. Pharmacies are hitting artificial ordering limits for controlled substances, which makes filling prescriptions even more difficult. Executive Summary: -Quotas for 2027 should be published by September 2026, to give pharmaceutical manufacturers time to properly acquire the highest quality ingredients, properly schedule time at CDMOs, and have extra time for inevitable supply chain disruptions. -Other necessary adjustments should be made to the Quota system to allow for the slow and methodical manufacturing of ADHD medications, such that they will be maximally effective for patients, with minimal side effects. -Quotas that anticipate future medical demand for the drug, based on constant trends, eg. The constant growth rate of ADHD medications in recent years. -Defined and generous ordering limits for Schedule 2-5 drugs by pharmacies should be made, eg, ‘ADHD meds should make up less than 6% of orders’ because it may help prevent Wholesalers from imposing artificial limits on ordering. A significant number of ADHD patients are highly sensitive to differences between specific manufacturers of ADHD medications. The shortages have made it incredibly difficult to access preferred generics, and many patients, including myself are experiencing subpar therapeutic results, and exorbitant side effects from generic ADHD medications. Like myself, many patients have had their providers drastically and suddenly increase doses to compensate for sub-therapeutic effects. Pharmacies are hitting artificial ordering limits for controlled substances, which makes filling prescriptions even more difficult. What life is like as an ADHD patient? Having a medical need for ADHD medications has, in recent years, been a repeated multi month-long affair of despair, agony and hopelessness. Every month you play Roulette with your health again, with no end in sight. After exhaustively calling more than 20 pharmacies, most of which will never give information on controlled substances they have in stock, most ADHD patients find that they must settle for subpar generics in the best of months and skipping medications altogether in the worst parts. Doctors are reporting that patients are requiring sudden and vast increases in their doses, often outright double it, to experience any therapeutic effect. These same patients find medications made before the pandemic stocked away in a closer work just as well as they did, at their older and lower dose. Now, imagine the horror, when you finally get your preferred manufacturer, only to find it is far less consistent than it was, some fills work flawlessly, while others feel as horrible as the worst generics, some batches firm, while of the same manufacturer crumble to dust. Any illusion of a medical haven is shattered, as you cling on desperately, to prevent the rest of your life from shattering like your health. I have experienced all the above, I had to call between 50 and 70 pharmacies just to have the brand for Dexedrine Spansules filled, after waiting a year for it to come back in stock. Unfortunately, the brand doesn’t work for me as well as the old Actavis generic, so my dose My therapeutic dose had doubled. I sincerely hope that my suggestions are carefully considered, and the description above paints a just picture of the SEMI-DYSTOPIAN landscape faced by ADHD patients.