American Enterprise Institute resident fellow and former FDA deputy Scott Gottlieb told a Drug Information Association conference in June that there is “fairly strong” sentiment within the agency favoring creation of a third, behind-the-counter (BTC) drug class between Rx and OTC.
However, he said, some physicians have raised safety issues, questioning whether consumers should self-medicate with products that are only available by prescription, and expressing doubts that appropriate patient monitoring is possible without medical supervision. He said another motive for physicians' opposition might be the prospect of losing revenues generated by repeat office calls for monitoring.
“Before FDA would consider a product for re-classification to OTC, for example,” he said, “the agency must be assured that the product has a favorable adverse event profile, and that use of the product requires no special monitoring.”
He said that these same criteria, if applied to BTC switch, might rule out switching products used to treat BPH (benign prostatic hyperplasia), as good medical practice dictates that patient screening for prostate cancer be accomplished prior to going on medications.