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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