In March 2022, an article on KevinMD brought attention to critical problems surrounding generic ADHD medications, particularly a formulation by Mallinckrodt. Unlike Concerta, which utilizes an osmotic-controlled release system, the Mallinckrodt version functions more similarly to Ritalin LA, leading to unpredictable medication release. This variability resulted in inconsistent energy levels and focus for patients, starkly contrasting with Concerta’s reliable delivery system.

An “authorized generic” produced by Watson, which is chemically identical to Concerta due to its production by Janssen, preserved the original’s steady release profile, highlighting that not all generics are the same in terms of effectiveness. These variations illustrated how certain generics can significantly disrupt everyday life and routines.

FDA oversight, spurred by advocacy efforts, ultimately reclassified the bioequivalence ratings of some generics, including those from Mallinckrodt, from AB to BX, acknowledging their lack of equivalency. However, these generics continued to be prescribed due to misunderstandings of ratings or pressures from insurers.

This scenario highlights the vital importance of bioequivalence in complex drug delivery and the need for transparency. It stresses that generics must be evaluated not solely on their chemical composition, but also regarding their delivery mechanisms, ensuring they provide similar therapeutic results. This example underscores the necessity for regulatory diligence and informed advocacy.