House to Vote on Bills to Update FDA’s Purple and Orange Books This Week

Regulatory NewsRegulatory News | 06 May 2019 |  By 

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.

For instance, Takeda noted: “More than 97 percent of products listed in the Purple Book that are eligible for exclusivity have no exclusivity determination.” The Association for Accessible Medicines also called on FDA to update the Purple Book to clarify which products have been determined not to have exclusivity (“e.g., those where any exclusivity period would have expired, if it applied in the first place”) and those that are still subject to pending decisions.

HR 1520, the "Purple Book Continuity Act of 2019," introduced by Rep. Anna Eshoo (D-CA), would require publication of the patents of approved biologics in the Purple Book in a similar format and with similar requirements to the Orange Book. It would also specify that the Purple Book should be published on FDA’s website and updated routinely, and it would direct FDA to consider the types of patents that should be listed in the Purple Book. 

In addition to the votes on the two bills, the Senate Committee on the Judiciary will hold a hearing Tuesday on intellectual property and the price of prescription drugs. On Thursday, the House Energy & Commerce Committee will hold a hearing on deconstructing the drug supply chain and lowering the cost of prescription drugs.


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