Bipartisan House group calls on FDA to ensure OTC and prescription versions of a drug cannot be marketed simultaneously
Reps. Debbie Dingell (D-MI), Robert Latta (R-OH) and Dan Crenshaw (R-TX) sent a letter yesterday to Patrizia Cavazzoni, the head of FDA’s Center for Drug Evaluation and Research, calling on the agency to not finalize a rule that would allow for the simultaneous marketing of OTC and prescription versions of the same drug.
The representatives said the proposal “flies in the face of a decades-old law to prevent this from occurring: When two products are used for the same condition, with the same indication, same dose, same strength, same form, and same route of administration, they ought to have the same legal classification.”
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