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  1. From Our Perspective

From Our Perspective: The Orange Book at 40: A Valued FDA Resource Continually Enhanced by User Input

Captain Kendra Stewart, Orange Book supervisor, discusses the Orange Book’s 40th Anniversary

Captain Kendra Stewart

October 31, 2020, marks the 40th anniversary of the first official publication of the U.S. Food and Drug Administration’s Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. One of FDA’s most-used resources, the Orange Book lists approved prescription drugs, related patent and exclusivity information, and therapeutic equivalence evaluations, along with other information. The evaluations it contains serve as public information and advice to state health agencies, prescribers, health care providers, and pharmacists. This useful information helps Orange Book users educate patients on drug selection and can help keep health care costs down for patients.

The Orange Book is the only official source for therapeutic equivalence evaluations and reference listed drug (RLD) data for FDA-approved generic and brand-name drugs. 

FDA evaluates approved multiple-source drugs for therapeutic equivalence and assigns a rating code which appears in the Orange Book. The therapeutic equivalence code ratings identify approved drugs that are pharmaceutical equivalents for which bioequivalence has been demonstrated, and that can be expected to have the same clinical effect and safety profile when administered under the conditions specified in the labeling. These ratings serve as a guide for generic substitution among drugs.

The Orange Book is particularly critical to determining when a pharmacist can substitute a generic drug for the brand-name drug. According to the Association for Accessible Medicines, 90% of all prescriptions dispensed in the United States in 2019 were filled with a generic drug.

Upcoming Event
The Center for Drug Evaluation and Research’s (CDER) Office of Generic Drugs (OGD) and Small Business and Industry Assistance program is hosting the first-ever Orange Book conference. The conference, Celebrating 40 Years: An In-Depth Examination of the FDA Orange Book, will be held virtually October 27 and 28, 2020. This two-day event will showcase the Orange Book and the rich information it contains. OGD Director Sally Choe, PhD, will provide the keynote address. This conference will be a great opportunity for the generic drug industry to hear from the agency’s Orange Book experts and provide their own feedback on its use and functionality.

Information Contained in the Orange Book

This particular database of FDA-approved drugs contains information on approved prescription drugs with therapeutic equivalence evaluations, approved over-the-counter drugs for those drugs, biologics approved under Section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and a list of discontinued drugs. (For details on these categories, please see the introduction of the Orange Book Preface.)

The Orange Book provides information regarding whether each approved drug is a new drug application (NDA) or abbreviated new drug application (ANDA), and, where eligible, has patent and/or exclusivity information. Additionally, the Orange Book identifies an RLD – the drug to which the ANDA applicant must show its proposed generic drug is the same. It also identifies the reference standard – the drugs selected by FDA – that an applicant seeking approval of an ANDA must use in its testing to establish the generic product’s bioequivalence or “sameness” to the brand product. Finally, it identifies the generic drugs that are therapeutically equivalent to a given RLD, along with relevant information, and indicates whether products are currently marketed in the U.S. 

The agency updates the database daily for generic drug approvals and patents and monthly for NDA approvals, revisions to approved applications, and new exclusivity determinations. Users can search for products by active ingredient, applicant holder, proprietary name, application number, or patent information.

Upcoming Event
CDER’s Division of Drug Information is hosting an Orange Book webinar November 16, 2020, at 1:00 p.m. EST. The webinar, Orange Book: Frequently Asked Questions and Answers, will feature Captain Kendra Stewart, Orange Book supervisor, and will assist stakeholders in using the Orange Book. It will address some of the most frequently asked questions that FDA has received from interested parties regarding the Orange Book. Attendees can earn continuing education credits. 

Orange Book History

The Orange Book was first proposed in January 1979 with the first edition finalized in October 1980. While the formal name is "Approved Drug Products with Therapeutic Equivalence Evaluations," the nickname “Orange Book” relates to the color commonly associated with Halloween, which is the date of the publication’s finalization—October 31, 1980—and to the orange-colored cover of the printed book. FDA decided to publish the Orange Book after the repeal of brand name, anti-substitution laws by individual states. The need to compile a list of marketed drugs that were approved for safety and efficacy became obvious as the agency received many requests for assistance in developing drug formularies. 

The Hatch-Waxman Amendments, also known as the Drug Price Competition and Patent Term Restoration Act of 1984, amended the FD&C Act to require, among other things, that FDA make publicly available a list of approved drugs with monthly supplements, which in turn, codified the publication of the Orange Book.

Other milestone developments include: The launch of the Orange Book website, which first appeared on FDA.gov in 1997, and the availability of the Orange Book as a mobile application (Orange Book Express) in 2015.

Recent Efforts to Improve Transparency, Accessibility, and Usefulness

The Orange Book is one of FDA’s most popular resources. Over the last 40 years, FDA has updated and enhanced it to make it more accessible and useful. These enhancements have included providing additional reference information and search functionality. This year, an Orange Book-focused guidance, one public docket to gather comments on how stakeholders and the public use the Orange Book and how it can be improved and another public docket to gather comments on the listing of patent information in the Orange Book were published. There are two planned events to help educate and engage Orange Book users (see sidebar).

You can find more information in the Orange Book Preface, or contact the Orange Book Staff at OrangeBook@fda.hhs.gov.

Captain Kendra Stewart is the Supervisor of the Orange Book Staff within FDA’s Center for Drug Evaluation and Research’s Office of Generic Drug Policy. Prior to joining FDA, Captain Stewart was a clinical pharmacist at both the James A. Haley Veterans’ Hospital and the Baltimore Veterans Affairs Medical Center. Captain Stewart has been a commissioned officer of the United States Public Health Service since 2003. She received her Doctor of Pharmacy degree from the School of Pharmacy, Florida A&M University.


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