Experimental Drug Access Push Won’t Slow Approvals, FDA Says

An FDA effort to encourage more drug companies to offer unproven therapies to terminally ill patients could steer patients away from another new model without agency oversight.

Drug companies shouldn’t experience delays bringing new medicines onto the market if they offer unapproved therapies to patients after the clinical trial ends, leaders at the Food and Drug Administration said in a recent statement. The agency builds on previous statements issued over the past several months that aim to build confidence in the expanded access program, which allows patients with life-threatening conditions who have run out of options to access experimental ...