FDA sued by ADHD generics maker for revoking drug's Concerta bioequivalence
- Because of a lack of bioequivalence, two versions of methylphenidate manufactured by Mallinckrodt and UCB can no longer be automatically substituted at the pharmacy level for Johnson & Johnson's Concerta, the WSJ reports.
- The companies were given six months to provide data showing bioequivalency or have their products withdrawn from the market, but did not meet the deadline. And yet the drugs are still being sold as of now.
- UCB is working with the FDA to try to meet the agency's requirements. However, Mallinckrodt has not made any moves towards compliance, and filed a lawsuit last fall saying the agency overstepped its bounds and did not tell the company about its decision in a timely manner.
The idea of bioequivalence, which means that the generic drug works in the body the same way as the originator drug, is axiomatic for makers of generic drugs. In fact, under the auspices of Hatch-Waxman generic drugs have to demonstrate sameness in terms of having the same active ingredient, route of administration, dosage form, strength, and intended use in order to be considered an approvable generic.
What's happening now between Mallinckrodt and the FDA is a showdown of sorts in that the FDA has deemed Mallinckrodt's version of methlphenidate not bioequivalent, yet the drug continues to be sold as a generic at pharmacies, including CVS and Rite Aid.
Although Mallinckrodt is communicating with the FDA, there are lingering concerns among experts that a non-bioequivalent drug may not be therapeutically equivalent, even if it is deemed safe for patients.