FDA’s Orange and Purple Books to be improved and updated

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FDA’s Orange and Purple Books to be improved and updated

Home/Policies & Legislation | Posted 31/05/2019 0 Post your comment

On 8 May 2019, the US House of Representatives unanimously passed two bills that aim to enhance the utility of the US Food and Drug Administration’s (FDA) Orange Book for generics makers and the Purple Book for biosimilars makers.

FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations Publication or ‘Orange Book’ lists pharmaceuticals and their generic equivalents. It includes patent and exclusivity information and identifies whether a drug is currently being marketed or has been discontinued. The publication is widely used by both the regulatory community and by physicians in order to identify which drugs are substitutable for one another [1].

The ‘Purple Book’ is a set of lists of licensed biological products and biosimilars that is meant to be the biological equivalent of the ‘Orange Book’ [2].

The Orange Book Transparency Act of 2019 (H.R. 1503) would remove invalid patents and add patents for drug delivery devices to the reference guide for generics makers. The bill will also help to ensure that the Orange Book is up-to-date by requiring manufacturers to share complete and timely information with FDA, as well as ensuring that only ‘applicable’ patents or exclusivity periods are listed. Invalidated patents would be required to be removed promptly. FDA will also be required to review the types of patent information that should be included on the list and report its recommendations back to Congress no later than one year after the bill becomes law.

The Purple Book Continuity Act of 2019 (H.R. 1520) would similarly reform the reference guide on biosimilars to include new patent information. The bill will bring about the publication of the patents of approved biologicals in the Purple Book in a similar format and with similar requirements to the Orange Book. It also specifies that the Purple Book should be published on FDA’s website and that it be updated routinely. In fact, newly licensed products should be included in the list within 30 days. It would also direct FDA to consider the types of patents that should be listed and which exclusivity periods are applicable to which products. FDA will also be required to review the types of patent information that should be included on the list and report its recommendations back to Congress no later than three years after the bill becomes law.

Both bills have now been introduced to the US Senate, read twice and referred to the Committee on Health, Education, Labor, and Pensions. If passed in the Senate they will then be referred to the president for signature and will become law.

FDA to improve Orange Book: issues draft guidance on marketing status

References
1. GaBI Online - Generics and Biosimilars Initiative. FDA debuts purple book for biologicals and interchangeable biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 May 31]. Available from: www.gabionline.net/Biosimilars/General/FDA-debuts-purple-book-for-biologicals-and-interchangeable-biosimilars

2. GaBI Online - Generics and Biosimilars Initiative. FDA updates Purple Book for biologicals and biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 May 31]. Available from: www.gabionline.net/Biosimilars/General/FDA-updates-Purple-Book-for-biologicals-and-biosimilars

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Source: congress.gov, house.gov, RAPs