United States: FDA Commissioner's Statement On Plans For The Orange Book

After dropping hints in recent months that he intended to use creative policy efforts to promote competition in the American pharmaceutical industry, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb issued an official statement on January 30, 2019,3 setting a policy agenda for the coming year that includes enhancing the utility of the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations Publication, known as the "Orange Book."

The Commissioner noted "the important benefits of a modern, up-to-date Orange Book" for patients, healthcare providers, and generic drug developers.4 To that end, he unveiled "several new steps" that the FDA would be putting in place to ensure that the Orange Book "provides as much utility as possible to aid manufacturers as they allocate resources towards the development of new generic drug products."5

I. January 2019 Draft Guidance

The first of these Orange Book-related actions is new draft guidance from the FDA, entitled "Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format."6 This January 2019 draft guidance stemmed from the FDA Reauthorization Act of 2017, or FDARA, which required NDA and ANDA holders for the first time to provide the FDA with (1) written notice 180 days before withdrawing a drug from sale; (2) written notice when an FDA-approved drug would not be available for sale within 180 days of FDA approval; and (3) a one-time report for all NDA and ANDA holders by February 14, 2018, stating whether the holder's drug(s) in the "active" section of the Orange Book were available for sale, had been withdrawn from sale, or were never available for sale.7

The draft guidance provided the FDA's current thinking on the definition of "withdrawn from sale" for purposes of the FDARA reporting requirements. Citing a 1989 proposed rule amending the ANDA regulations, the agency described its policy regarding withdrawal as "if the applicant has ceased its own distribution of the drug, whether or not it has ordered recall of previously distributed lots of the drug. A routine, temporary interruption in the supply of a drug product would not be considered a withdrawal from sale, however, unless triggered by safety or effectiveness concerns."8 Withdrawal is interpreted to include "any decision to discontinue marketing of [that] product," whether permanent or not.9 Notification to the FDA that the product is not being marketed by the NDA or ANDA holder is considered a withdrawal.10 The draft guidance also provides preferred formats for the written notifications for withdrawal from sale and unavailability for sale.11

The FDA intends to provide enhanced transparency and accuracy in the Orange Book with regard to the drugs for which generic competition is lacking.12 For drugs that are no longer truly "active," they can be moved to the "discontinued" section of the Orange Book, or if removed from sale due to lack of safety or effectiveness, taken out of the Orange Book altogether.13 Without these notices, the value of the information Orange Book would decay rather quickly; the FDA expects to receive approximately 523 withdrawal notices per year, and 30 "unavailable for sale" notices per year under the FDARA reporting requirements.14 The FDA also received 10,319 of the mandated one-time reports due in February 2018.15

Commissioner Gottlieb also highlighted the importance of the written notices and the updated Orange Book to FDA policymaking, noting that the information "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."16 This echoed the Commissioner's remarks on January 8, 2019, at the annual J.P. Morgan Healthcare Conference in San Francisco, CA that "[o]ne of my growing concerns [is] we're approving a lot of drugs, but not seeing a commensurate number of drugs launched."17,18 In conjunction with the U.S. Patent and Trademark Office, Commissioner Gottlieb stated that the FDA would look at updating the Orange Book so that the two agencies could determine "how we can facilitate more generic drug launches, not just approvals."19

II. Two More Expected Draft Guidances in 2019

The FDA plans to issue two more Orange Book-related FDA draft guidance in the coming months. The first expected draft guidance will be directed to industry, and will describe how the FDA evaluates therapeutic equivalence and assigns therapeutic equivalence codes, which appear in the Orange Book for a given drug product.20 According to the Commissioner, the intended draft guidance will "increase transparency" around the agency's policies concerning requests for therapeutic equivalence, including those via the 505(b)(2) pathway.21 The Statement hints that "the agency is developing policy for how manufacturers can acquire a therapeutic equivalence rating to allow for full substitutability" for products developed via the 505(b)(2) pathway, and that this could provide more competition for "harder-to-copy complex drugs."22

The second expected future draft guidance sounds like it will be a resource for applicants and approved application holders from the FDA on how to use the Orange Book, including answers to "commonly asked questions."23

III.Expected Request for Public Comments

In addition, the FDA will solicit public comments on the Orange Book, how it is used, and how it can be improved, including input on which patents should be listed for a given drug product.24 The Commissioner specifically identified products that have been approved in conjunction with a digital application, such as a mobile app or other software product, stating that the FDA will seek public comments on whether patents involving these applications should be listed in the Orange Book for the associated drug products.25 According to the Commissioner, "listing such patents could help generic developers to assess all intellectual property assertions related to the product that could potentially block generic entry and determine its approach to these patents."26 In turn, this listing "could allow generic competitors to better assess which products they choose to develop and provide better clarity as to the path to market."27

The Commissioner's statement closes with a reinforcement of the FDA's stated goal of "enhanced competition," and confirms that these Orange Book initiatives are only the beginning of a series of transparency-related initiatives relating to drug policy over the next year. Stakeholders in the pharmaceutical industry should monitor these developments and seek legal counsel as appropriate.


1. Dr. O'Quinn is an associate in the Reston, Virginia office of Finnegan, Henderson, Farabow, Garrett & Dunner, LLP.

2. Dr. Cyr is a partner in the Reston, Virginia office of Finnegan, Henderson, Farabow, Garrett & Dunner, LLP.

3 Scott Gottlieb, M.D., "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," Jan. 30, 2019, ("Statement"), available at https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm630098.htm.

4. Statement, supra note 3.

5. Id.

6. "Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format," Draft Guidance for Industry (January 2019) ("Draft Guidance"), available at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM630099.pdf

7. See Statement, supra note 3; see also Draft Guidance, supra note 6, at 2:56-68; FDA Reauthorization Act of 2017, codified in relevant part at 21 U.S.C. § 356i (2018).

8. Draft Guidance, supra note 6, at 3:73-80 (quoting "Abbreviated New Drug Application Regulations," proposed rule, 54 Fed. Reg. 28872, 28907 (July 10, 1989)).

9. Id. at 3:70-72 (quoting "Abbreviated New Drug Application Regulations," final rule, 57 Fed. Reg. 17950,17956 (Apr. 28, 1992) (alteration in original)).

10. Id. at 3:82-83 (citing Orange Book Preface (38th ed., 2018) at xxiv).

11. Id. 3:96 – 5:143.

12. Statement, supra note 3.

13. See Draft Guidance, supra note 6, at 3:85-90.

14. Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format; Draft Guidance for Industry; Availability, 84 Fed. Reg. 749, 751-52 (Jan. 31, 2019).

15. Id.

16. Statement, supra note 3.

17. https://www.jpmorgan.com/global/healthcareconference

18. See Alaric DeArment, "In JPM interview, Gottlieb outlines FDA efforts to promote biopharma competition," MedCity News, Jan. 8, 2019, 5:30 PM, available at https://medcitynews.com/2019/01/in-jpm-interview-gottlieb-outlines-fda-efforts-to-promote-biopharma-competition/?rf=1.

19. See id.

20. Statement, supra note 3.

21. Id.

22. Id.

23. Id.

24. Id.

25. Id.

26. Id.

27. Id.

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