On January 30, 2019, FDA Commissioner Scott Gottlieb issued a statement on FDA's efforts to enhance the utility of the Orange Book to foster drug competition. Noting the benefits of a modern, up-to-date Orange Book, the Commissioner announced several steps that FDA is taking.
First, FDA issued draft guidance in January 2019, entitled "Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format." This guidance identified the required content for marketing status notifications, the recommended format for submitting the notifications to FDA, and the required timelines for submission.
Second, FDA will issue guidance for industry regarding how it evaluates therapeutic equivalence and assigns therapeutic equivalence codes. According to the Commissioner, FDA believes this guidance will be particularly beneficial for those seeking to develop generic products for harder-to-copy complex drugs.
Third, FDA will issue guidance to assist drug product applicants and approved application holders in using the Orange Book, including answers to commonly asked questions.
Fourth, FDA plans to solicit public comment on Orange Book use and potential enhancements. According to the Commissioner, this will include reexamining what pharmaceutical patents should be listed in the Orange Book and whether it should include, for example, patents associated with the digital application for products approved in conjunction with a digital application.
Readers are encouraged to read the Commissioner's statement, also available on FDA's website.
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