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# Cassidy Wants Info on Orange Book Listing Requirements
- URL: https://www.fdaweb.com/cassidy-wants-info-on-orange-book-listing-requirements/
- Published: 2024-10-01T12:00:00.000Z
- Updated: 2026-09-14T14:42:51.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5157890

Sen. **Bill Cassidy** (R-LA) is asking FDA to explain why it has failed to provide clarity to drug manufacturers on properly listing their products’ patents in the *Orange Book*. In a 9/30 [letter](https://www.help.senate.gov/ranking/newsroom/press/ranking-member-cassidy-requests-answers-on-fdas-failure-to-provide-clarity-on-drug-patent-listings?ref=fdaweb.com) to FDA commissioner **Robert Califf**, Cassidy says that for decades, brand and generic drug manufacturers have struggled with how to list patents for the device parts of drug/device combination products in the *Orange Book*.

“Despite Congress’ clear charge to FDA to set the rules for listing patents in the *Orange Book*, FDA has been absent,” Cassidy writes. “The agency has refused to provide needed clarity on listing patents for drug/device combination products…. Meanwhile, the Federal Trade Commission (FTC), with FDA’s apparent encouragement, has filled the vacuum left by FDA. FTC has encroached on FDA’s jurisdiction by policing *Orange Book* listings under antitrust law…. FDA’s continued silence on this issue is untenable, and patients ultimately stand to benefit through clarity on these requirements.”

Cassidy asks for answers to these questions:

- the status of any work product from an FDA multidisciplinary working group on patent listing created in 1/2022;
- the cumulative result of FDA efforts through the working group and the solicitation of comments through a public docket;
- FDA’s stand on the need to provide more clarity about the listing of patents for drug/device combination products and why the agency has failed to clarify through some means the scope of patents that must be listed;
- the pros and cons of listing patents related to the device constituent of drug/device combination products;
- FTC’s actions related to *Orange Book* patent listings;
- whether a 30-month stay for a drug has ever hinged on a patent for a device constituent of a drug/device combination product and details of any such situation;
- how often (with example details) FDA has granted tentative approval to an ANDA where the sole obstacle to full approval was a patent for a device constituent of a drug/device combination product;
- if FDA has remained silent due to negative unintended consequences that could come from restricting patent listings, why it has encouraged FTC to take enforcement action; and
- whether Congress should amend the Federal Food, Drug, and Cosmetic Act to clarify the patent listing requirements.