WASHINGTON — A bipartisan duo of senators wants to give the Food and Drug Administration the power to add off-label uses to certain generic drug labels.
Sens. Orrin Hatch (R-Utah) and Michael Bennet (D-Colo.) introduced legislation late Thursday that would put in place new requirements on generic drug makers and FDA.
Right now, drug makers can only market a drug for a new use — like treating a different condition or offering a different dosage — if they spend the time and money to submit a label change to the FDA. Generic drug makers, however, can’t launch that process. Only branded drug makers can.
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