Who Is in Control?
Off-label drug use can sometimes evoke negative connotations and may diminish public expectations that drugs will go through the rigorous testing required by the FDA, experts say.
The big question, Alexander says, is how to best regulate off-label drug use without unduly stifling clinical innovation. Some have called for a greater emphasis on evidence-based prescribing, with stricter rules governing off-label drug use. But others worry that tightening the reins could hinder patients' early access to novel therapies.