FDA's Efforts To Modernize The Orange Book

On June 1, 2020, the U.S. Food and Drug Administration (FDA) published a series of Federal Register notices addressing the agency's efforts to modernize and provide clarity on key issues concerning FDA's "Approved Drug Products with Therapeutic Equivalents" publication, commonly known as the Orange Book. Specifically, FDA announced it has opened two public dockets to seek comments on enhancements that can be made to the Orange Book's patent listing and therapeutic equivalence information and also issued a new draft guidance document, entitled "Orange Book: Questions and Answers Guidance for Industry." These efforts, according to the agency, are intended to facilitate generic competition, promote patient access, and improve the economics of developing generic medicines.