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Possible Orange Book Revisions Back In Play With US FDA Report To Congress

 
• By Brenda Sandburg

Agency is setting up an internal working group to assess whether certain patent information should be included or removed from the Orange Book. PhRMA, AAM and others address therapeutic equivalence ratings and listing of device-related and REMS-related patents.

US FDA is evaluating whether to make improvements to its Orange Book • Source: Alamy

The Orange Book Transparency Act signed into law last year required the US Food and Drug Administration to solicit public comments on what patent information should be included in the Orange Book. The agency had already completed this task, so it reopened the docket for further input and is now evaluating possible revisions to the publication.

Last month, the FDA submitted a report to Congress summarizing the comments it received without specifying who made the comments or responding to them. The agency also noted that...

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