Posted by Michael Wonder on 30 Jan 2019
Statement from FDA Commissioner on the agency’s efforts to enhance the utility of the Orange Book to foster drug competition
30 January 2019 - One of our key policy priorities is encouraging the timely development and approval of generics and biosimilars.
Our efforts have helped foster competition in the marketplace with the ultimate goal of improving access to high quality, affordable treatment options for Americans and improving patient care.
We’ve made significant progress over the past year advancing efforts that have helped to strengthen and streamline the generic drug review process – setting record numbers for generic drug approvals and tentative approvals from 2017-2018; providing scientific clarity and guidance to support the development of hard-to-develop complex generics; and calling out potential abuses of the system where companies were using tactics to delay market entry of generic competitors. We will continue to advance new efforts in the year ahead. Our aim is to enhance transparency, provide greater clarity and scientific guidance for generic drug developers, and support the availability of high-quality, safe and effective generic medicines.
