House Unanimously Passes Bills Updating FDA’s Orange and Purple Books

Regulatory NewsRegulatory News
| 08 May 2019 | By Zachary Brennan 

The US House of Representatives on Wednesday unanimously passed two bills that would increase the utility of the US Food and Drug Administration’s (FDA) Orange Book for generic drugmakers and Purple Book for biosimilar developers.

“Ensuring these databases are up-to-date will help prevent patent listing errors that delay more affordable alternative medications from coming to market sooner,” House Energy and Commerce Committee Chairman Frank Pallone (D-NJ) and Health Subcommittee Chairwoman Anna G. Eshoo (D-CA) said in a joint statement Wednesday.

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.

The passage of HR 1503, the "Orange Book Transparency Act of 2019," introduced by Rep. Robin Kelly (D-IL), will 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 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. Drugmakers have pushed back on the limited scope of the Purple Book.

The passage of HR 1520, the "Purple Book Continuity Act of 2019," introduced by Rep. Anna Eshoo (D-CA), will bring about the 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 and which exclusivity periods are applicable to which products. 

Within three years, the Secretary of Health and Human Services will also solicit public comment on the types of information that should be added or removed from the Purple Book, the bill’s text says. A similar bill has been introduced in the Senate by Sens. Rob Portman (R-OH), Jeanne Shaheen (D-NH), Mike Braun (R-IN) and Debbie Stabenow (D-MI).


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