How two bills on the Purple and Orange Books could help drugmakers and doctors

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Alexander Gaffney Senior Manager, Health Research Institute, PwC US May 17, 2019

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Developers of generic drugs and biosimilar products may soon find it easier to identify barriers to bringing their products to market through two pieces of legislation unanimously passed by the US House of Representatives last week involving the Orange Book and the Purple Book. 

The bills, the Orange Book Transparency Act of 2019 and the Purple Book Continuity Act of 2019, aim to increase transparency and ease the use of two FDA databases—the Orange Book, which contains information about chemical drugs and generics, and the Purple Book, which contains information about biological drugs and biosimilars.

The bills require drug companies to include all patent information applicable to the drug substance, including formulation and methods of use, as well as marketing exclusivity information that would preclude the marketing of a drug. Companies also would be required to notify the FDA if their patent is found to be invalid so it can be removed from the FDA’s database, and the Purple Book would have to be upgraded from its current form—a PDF printout—to a searchable database format.

These valuable databases are used extensively by physicians seeking information about pharmaceuticals, such as the extent to which one drug is generic to another. They are also used by drug manufacturers looking for, for example, patent information.

HRI impact analysis

Increasing the availability and ease with which the public and industry can find and access drug information may benefit developers of generic drugs and biosimilars, as well as physicians. Currently, the Orange and Purple Books lack complete and accurate patent information that would be helpful for developers of generic and biosimilar drugs.

The Purple Book, in particular, lacks all but the most basic information about biological products, leaving developers without any insight into key barriers to market entry and physicians without access to information that would help guide prescribing decisions. For aspiring developers of generics and biosimilars, up-to-date patent information will better help them identify which drugs are subject to competition and the patents they will either need to wait out or challenge.

Contact us

Trine K. Tsouderos

HRI Regulatory Center Leader, PwC US

Tel: +1 (312) 241 3824

Alexander Gaffney

Senior Manager, Health Research Institute, PwC US

Tel: +1 (202) 836 1604

Jason Ranville

Senior Manager, Health Research Institute, PwC US

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