File this under “Not so fast!”
Two drug makers — Mallinckrodt and Lannett — are fighting the US Food and Drug Administration over a plan the agency announced last week to withdraw their generic versions of the Concerta pill for attention deficit disorder. Mallinckrodt is trying to contest the move in court, while Lannett plans to seek a hearing in hopes of convincing the agency to change its mind.
The agency took this step after determining the generic drugs were not equivalent to the brand-name pill, an issue that actually arose two years ago and prompted the FDA to downgrade regulatory ratings for the copycat drugs. This was an unusual move and meant that the generic versions, which contain the same active ingredient as Concerta, could no longer be automatically substituted at pharmacy counters.
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Does this ‘narrowing’ mean the prices have been climbing as is now ‘usual and customary,’ it seems?
Memo to Mallinckrodt and Lannett: Bioequivalence is not defined as “in the ballpark” much as you would like it to be. The efficacy of these copycats wears off after about seven hours, just in time for little Johnny to miss his stop on the school bus route.