A 2022 KevinMD article raised considerations about generic formulations of ADHD medicines. The creator described what many sufferers and households had already found: Not all generics are created equal. For these of us who lived by means of the substitutions, the distinction was not summary. It was a curler coaster that intruded on each day life, even on trip.
The generic in query was manufactured by Mallinckrodt. In contrast to Concerta, which makes use of an osmotic-controlled launch oral supply system (OROS), Mallinckrodt’s model relied on a launch profile nearer to Ritalin LA. The excellence issues. Concerta’s osmotic pump delivers methylphenidate steadily all through the day, minimizing peaks and troughs. Mallinckrodt’s spherical pill, in contrast, produced bursts of remedy adopted by crashes. Sufferers who had relied on Concerta’s easy arc abruptly discovered themselves using waves of vitality, focus, and irritability.
Against this, Watson’s generic was not a real generic in any respect. It was an “approved generic,” manufactured by Janssen (the maker of Concerta) and despatched to Watson below settlement with it. It’s unimaginable to inform them aside as a result of the identical manufacturing unit made each merchandise with the identical imprint. Chemically and mechanically an identical to the model, Watson’s model preserved the osmotic launch system. The one distinction is the label on the massive bottle of the remedy despatched to pharmacies. For sufferers, the distinction between Mallinckrodt’s pill and Watson’s approved generic was the distinction between stability and chaos.
My family skilled this firsthand. On trip, Kathy and Robert have been subjected to the substitution. As a substitute of regular days, they endured unpredictable highs and lows. The remedy curler coaster disrupted meals, outings, and even sleep. What ought to have been restorative time collectively turned a lesson in how pharmacy substitutions can hijack household cadence. The issue was not ADHD itself; it was the formulation of the remedy meant to deal with it.
That is why the FDA’s position in bioequivalence rankings is so important. In 2016 and 2017, after sustained advocacy from clinicians and affected person advocates, the FDA downgraded the bioequivalence rankings of sure generics. Gina Pera and others documented the lived penalties of those substitutions, and the company finally acknowledged that the pharmacokinetic profiles weren’t equal. Pharmacies started to shift again to shelling out both model Concerta or the Watson-authorized model. For a lot of households, that change restored stability.
The FDA finally confirmed what households had lived. Inside six months, Mallinckrodt and Kudco have been requested to show bioequivalence or withdraw their merchandise. After they failed, the company downgraded their Orange Guide ranking from AB to BX. That bureaucratic shift was the official recognition that these tablets weren’t equal, and that the curler coaster was actual.
And regardless of this motion, Dr. Received was prescribed the BX generics slightly than the AB rated generic in November 2019. Regardless of the FDA’s regulatory science initiative and the downgrade from AB to BX, sufferers like Dr. Received have been nonetheless prescribed the BX generics in 2019. Why? As a result of the chain of care broke. Pharmacists both didn’t perceive the designation or have been pressured by insurers to disregard it. The FDA had executed its job; the well being care system had not.
However the lesson stays. “Generic” doesn’t at all times imply “equal,” particularly when the remedy includes complicated supply programs. With easy molecules, substitution could also be simple. With extended-release formulations, the mechanism of supply is as essential because the molecule itself. Sufferers deserve transparency about what they’re receiving, and clinicians deserve readability when prescribing.
The March 2022 article stays essential as a result of it captured a second in time when households have been nonetheless being subjected to ineffective substitutions. Seven months later, the panorama had begun to alter, however the reminiscence of these curler coasters lingers. For Kathy and Robert, the holiday disrupted by Mallinckrodt’s pill is a part of our household ledger. For me, it’s a reminder that advocacy should prolong past the clinic to the regulatory area.
Responding to an article like this requires each validation and replace. Validation, as a result of the creator’s lived expertise was actual and shared by many. Replace, as a result of the regulatory and pharmacy panorama has shifted since publication. Collectively, these components create a story that honors the previous whereas clarifying the current.
As a developmental pediatrician and psychopharmacology professional acknowledged by the FDA and the NIH, I’ve seen how remedy formulation can form not simply medical outcomes however each day life. As a historian, I acknowledge the significance of documenting these moments so they don’t seem to be forgotten. And as a father or mother, I do know the price of a disrupted trip. The curler coaster was not inevitable; it was imposed by a substitution that ought to by no means have been allowed.
The broader lesson is one in all vigilance. Sufferers and households have to be empowered to ask which generic they’re receiving. Clinicians have to be geared up to elucidate the distinction between approved generics and pharmacokinetic variations. Regulators should proceed to scrutinize bioequivalence claims, particularly for complicated supply programs. And platforms like KevinMD should proceed to amplify these tales, as a result of lived expertise is essentially the most highly effective proof of all.
Seven months after the article’s publication, the story stays related. It’s not nearly ADHD remedy. It’s concerning the that means of “generic,” the significance of supply programs, and the lived penalties of regulatory choices. For Kathy, for Robert, and for numerous households, the curler coaster was actual. Our accountability is to make sure it doesn’t occur once more.
Dr. Lindsay’s scholarship, profiled on ResearchGate and Doximity, extends throughout seventeen peer-reviewed articles, eleven e-book chapters, and forty-five invited lectures, in addition to contributions to main tutorial publishers reminiscent of Oxford College Press and McGraw-Hill. His memoir-in-progress, The Quiet Architect, threads testimony, resistance, and civic responsibility right into a reckoning with programs retreat.
