FDA guidance aims to increase generic competition for topical drugs

The Food and Drug Administration yesterday released a series of guidance documents intended to help manufacturers develop generic transdermal and topical delivery systems, products that deliver a drug through a patient’s skin. “Because of the inherent complexity of delivering a drug through a TDS, making generic copies of these complex drugs can be especially hard,” said FDA Commissioner Scott Gottlieb, M.D. “As a result, many branded TDS products like drug patches have not faced timely generic competition.” He said FDA has “made a new commitment to develop product specific guidance documents laying out how to develop a generic copy of a branded medicine for any currently marketed, branded complex medicine in an effort to advance a more efficient and effective framework for developing generic copies of complex drugs.”