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# House Passes 2 Bills on Orange and Purple Books
- URL: https://www.fdaweb.com/house-passes-2-bills-on-orange-and-purple-books/
- Published: 2019-05-08T12:00:00.000Z
- Updated: 2026-09-15T01:25:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144064

The House has passed two bipartisan bills that would make updates to FDA’s *Orange Book* and *Purple Book* to improve accuracy and transparency of the two databases that guide development decisions for generic and biosimilar manufacturers. They are:

H.R. 1503, the *Orange Book* Transparency Act of 2019, from Reps. **Robin L. Kelly** (D-IL) and **Brett Guthrie** (R-KY). It is intended to codify the current requirement to list drug substance patents, drug product patents, and method-of-use patents; and allows the listing of other patents at agency discretion. It further requires manufacturers to notify FDA of any court decision finding a patent invalid and requires that FDA remove those patents from the *Orange Book* to ensure the database is up to date.

H.R. 1520, the *Purple Book* Continuity Act of 2019, from **Anna G. Eshoo** (D-CA) and Rep. **Michael C. Burgess** (R-TX). It is intended to codify the requirement to list: name of biologic; date of licensing; studies necessary for biosimilar applications; updates every 30 days; patents disclosed during “patent dance”; and withdrawal or suspension of licensure. In addition, the bill requires FDA to report recommendations of what patents should be listed in the *Purple Book* going forward. The legislation also increases the *Purple Book*’s utility by requiring it to be made public in a more usable format.