FDA Commissioner Scott Gottlieb, M.D. recently announced four steps FDA will be taking to ensure that the Orange Book (FDA’s publication of Approved Drug Products with Therapeutic Equivalence Evaluations) provides the greatest benefit to patients and providers, and (perhaps in particular) generic drug developers.  The Commissioner’s announcement addresses several important issues, including patent listing standards and therapeutic equivalence ratings.

Dr. Gottlieb said that in the coming year, FDA will issue draft guidance describing how the FDA evaluates therapeutic equivalence (TE) and assigns TE codes, which are published in the Orange Book.