Orange Book to foster drug competition | Statement from FDA Commissioner Scott Gottlieb, M.D. on the agency’s efforts to enhance its utility

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s efforts to enhance the utility of the Orange Book to foster drug competition

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.

One of the most fundamental and crucial tools for generic drug companies in planning their development efforts is the FDA publication Approved Drug Products with Therapeutic Equivalence Evaluations Publication (also known as the Orange Book). This is a list of drug products approved by the FDA under the Federal Food, Drug, and Cosmetic Act that includes patent and exclusivity information and identifies whether a drug is currently being marketed or has been discontinued. Maintaining an up-to-date Orange Book also serves many important public health roles. Among its many benefits, the Orange Book helps keep health care providers informed on what drugs are approved and available.

Given the important benefits of a modern, up-to-date Orange Book, today we’re announcing several new steps the agency will be taking to ensure that the Orange Book provides the greatest benefit to patients and providers, and generic drug developers. We want to make sure it provides as much utility as possible to aid manufacturers as they allocate resources towards the development of new generic drug products.

The first of these actions is a new draft guidance – Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format. The guidance provides approved drug application holders with clarity on the specific categories and descriptions of the information they’re required to share with FDA on the marketing status for their brand and generic drugs and how to provide it in a timely and consistent manner. Having timely, accurate information about what drugs are being actively marketed helps provide transparency around circumstances where generic competition is lacking. It helps us also better understand circumstances where generic medicines are being approved, but not marketed so that we can better consider any policy reasons why this may be occurring.

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