Comment on FR Doc # 2026-10128

James DavinSupportIndividual
Summary: The commenter, a private individual suffering from ADHD, argues that current regulatory oversight of ADHD medications is failing to ensure drug efficacy and quality. They advocate for stricter manufacturing standards, continuous dissolution surveillance, and periodic bioequivalence re-verification to ensure patients receive effective medication.
To the Appropriate Agencies of the United States Federal Government:Many of the scientific experts including Russell Barkley say that for easiest description of Attention Deficit Hyperactivity Disorder is best summed up as diabetes of the brain. The brain chemicals that most people take for granted on the most basic things such as motivation, organization, executive function, intention, focus, sleep efficacy and wakefulness, and chemicals that are critical to feeling well are all due to the appropriate amount of dopamine and norepinephrine. Can you imagine if our government not only made it difficult to get insulin to treat diabetes, but actually allowed all the manufacturers of the stimulant medications to manufacture brand and generics that don't have any efficacy and make people that are suffering terribly even sicker just because there may be a few people that are sadly abusing them....Well that is what those that have been legitimately diagnosed with ADHD have lived with in horror for six years since 2020. Just when you think it can not get worse it does. If there is any API in my dextroamphetamine it is not of the potency that enables the medication to cross the blood brain barrier. The terrible fillers and inferior excipients on top of non therapeutic API for a REAL SERIOUS MEDICAL CONDITION is making people sick on top of the dangerous consequences of untreated ADHD and all the paralyzing co-occurring conditions that travel with untreated or poorly treated adhd(depression, anxiety, substance abuse, ptsd ocd etc). I could write volumes on this as it has been the most consequential impact and outcomes in my life. I graduated from some of the top universities in the United States and performed at the top of my industry consistently for decades. I have lost two jobs that pay in excess of $200K in the last five years. I lost my marriage as well. I have felt terrible to the underdosing and terrible fake pills i have paid a fortune for in hopes it will become a real therapeutic treatment for my adhd again. I have had to drill into how and why this could happen in the United States of America. . There is a way to balance the needs of people with a real debilitating medical condition who rely on effective and efficacious medication to function and be a productive citizen for your family and community. This can and should be done while balancing any measures on diversion.....not just diversion and people with medical conditions that need the medicine be left out to suffer. I will not be able to get back the consequences that have been inflicted on me due to the ineffective medication.....but my hope is that the stimulants can become effective again so it can cross the blood brain barrier and allow people like myself with a genetic condition that runs deep in my family to just function again and above all feel a sense of well being that has been missing since 2020 and especially since 2023. I am attaching an analysis that i recently found online...its called whats in my meds....and it goes into great detail about the horrific and qunatity of changes on stimulants ..the FDA bioequivalence is an absolute joke on any neurosych meds...the ranges for be effective can not be between 80-125%....but if you read this factual info in the attachment....this is something way different and should not be happening even in a vitamin...not alone our pharmaceutical supply.and also at least most vitamin suppliers batch test their products...sure wish the FDA would allow this on our pharmaceuticals.

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