In August 2016, the Food and Drug Administration (FDA) launched an updated web-based version of its “Orange Book,” the publication on drugs approved on the basis of safety and effectiveness.
This major revision of the Orange Book, known more formally as the Approved Drug Products with Therapeutic Equivalence Evaluations, is a first for the website and features an updated design with user-friendly search options. Users can now search for approved drug products by active ingredient, proprietary name, applicant, application number, dosage form, route of administration or patent number. Groups of accordion panels can also be opened to reveal additional new features and contact information.
What is the Orange Book?
The Orange Book was first created in list form in an attempt to contain drug costs. Almost every state had adopted laws and/or regulations that encouraged the substitution of drug products. The state laws generally required either the substitution be limited to drugs on a specific list or that it be permitted for all drugs except those prohibited by a particular list. Due to the high volume of requests for FDA assistance in the late 1970s, it became apparent that the FDA was not going to be able to serve the needs of individual states and felt as though providing a single list based on common criteria would be preferable to evaluating drug products on the basis of differing definitions and criteria in various state laws.
On May 31, 1978, FDA Commissioner Donald Kennedy sent a letter to officials of each state, stating the FDA’s intent to provide a list of all prescription drug products that are approved by the FDA for safety and effectiveness, along with therapeutic equivalence determinations for multisource prescription products.
In 1979, the List was first distributed in January as a proposal. It included only currently marketed prescription drug products approved by the FDA through new drug applications (NDAs) and abbreviated new drug applications (ANDAs) under the provisions of Section 505 of the Food, Drug and Cosmetics Act.
A complete discussion of the background and basis of FDA’s therapeutic equivalence evaluation policy was published in the Federal Register on January 12, 1979 and the final rule was published on October 31, 1980. The first publication (October 1980) included appropriate corrections and additions to the final version of the List. Each subsequent edition has included new approvals and made appropriate changes in data.
On September 24, 1984, President Ronald Reagan signed into law the Drug Price Competition and Patent Term Restoration Act of 1984, requiring that the FDA make publicly available a list of approved drug products with monthly supplements. The Orange Book satisfies this requirement.
The Orange Book Today
Interested parties can also download the Orange Book application in the Apple App Store or Google Play. The application, Orange Book Express, allows users to search by the same parameters as the website; search all marketing statuses (Rx, OTC, Discontinued) with one simple search; look up patent and exclusivity information; identify Reference Listed Drugs and determine if a drug product has a therapeutic equivalent; and browse patent delistings and newly added patents.
This updated website is the latest move by the FDA to improve its online presence and follows the release of the 36th edition of the Orange Book in 2015.
The FDA intends to use the Orange Book to further its objectives of obtaining constant input and comments on the publication itself, and Agency procedures. If you have any comments on how the publication may be improved, send them to the Director, Division of Legal and Regulatory Support, Office of Generic Drugs, Center for Drug and Evaluation and Research, 7620 Standish Place, Rockville, MD, 20855-2773.