US: House to vote on Bills to update FDA’s Purple and Orange Books


US: House to vote on Bills to update FDA’s Purple and Orange Books

(Source: RAPS 2019-05-08)

The US House of Representatives is likely to vote on two bills this week that would reform FDA’s Orange Book on generic drugs and FDA’s Purple Book on biosimilars.

The votes are likely to occur Wednesday, according to the schedule of House Majority Leader Steny Hoyer (D-MD).

The Orange Book, which can be searched by drug name, applicant, dosage form, route of administration or patent information, is used as a resource by both brand name and generic drug companies to obtain timely information on medicines.

HR 1503, the "Orange Book Transparency Act of 2019," introduced by Rep. Robin Kelly (D-IL), would 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 patents listed in the Orange Book are relevant to the approved drug product. Invalidated patents would be required to be removed promptly.

The more recently created Purple Book, meanwhile, includes information on when biosimilars and interchangeable biosimilars were licensed and whether FDA evaluated the product for reference product exclusivity. But drugmakers have pushed back on the limited scope of the Purple Book.

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