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# FDA Enhancing Orange Book: Gottlieb
- URL: https://www.fdaweb.com/fda-enhancing-orange-book-gottlieb/
- Published: 2019-01-30T12:00:00.000Z
- Updated: 2026-09-15T00:58:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143261

FDA commissioner **Scott Gottlieb** says the agency is taking steps 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.” One step in that effort, he [says](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm630098.htm?utm%5Fcampaign=1302019%5FStatement%5FFDA%20statement%20on%20efforts%20to%20enhance%20the%20utility%20of%20the%20Orange%20Book&utm%5Fmedium=email&utm%5Fsource=Eloqua), is release of a new [draft guidance](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM630099.pdf?ref=fdaweb.com), *Marketing Status Notifications Under Section 5061 of the Federal Food, Drug, and Cosmetic Act; Content and Format*.

The guidance says it is intended to assist NDA and ANDA holders with submission of marketing status notifications required under Section 5061\. It identifies the required content for the marketing status notifications and the format by which the notifications should be submitted to the agency.

Gottlieb says 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 and 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.”

In the coming year, Gottlieb says, FDA will take other actions to enhance the resource and clarify *Orange Book* processes. He says the agency will issue draft guidance describing how it evaluates therapeutic equivalence and assigns therapeutic equivalence codes, which are published in the *Orange Book*. There also is to be a draft guidance to assist drug product applicants and approved application holders use the *Orange Book*. And FDA wants to solicit public comment on *Orange Book* use and potential enhancements, including a reexamination of what pharmaceutical patents should be listed in the book.