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# Lawmakers Ask FDA to Fix Orange Book Loopholes
- URL: https://www.fdaweb.com/lawmakers-ask-fda-to-fix-orange-book-loopholes/
- Published: 2023-08-29T12:00:00.000Z
- Updated: 2026-09-14T18:53:15.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155206

Senator **Elizabeth Warren** (D-MA) and Rep. **Pramila Jayapal** (D-WA) have written FDA commissioner **Robert Califf** urging him to restrict patents that are listed in the *Orange Book* to curb loopholes in the patent system that drug companies have “exploited to rake in billions in profits.”

The lawmakers complain in their [letter](https://www.warren.senate.gov/imo/media/doc/2023.08.28%20Letter%20to%20FDA%20re%20drug%20patents.pdf?ref=fdaweb.com) that brand pharmaceutical companies routinely abuse the *Orange Book* system by “improperly listing patents to block the introduction of lower-cost generics. If a brand-name drug company sues a generic competitor for infringing on an *Orange Book*\-listed patent,” they contiinue, "it automatically triggers a 30-month bar on the FDA’s ability to approve the competitor’s generic drug, therefore blocking the competitor’s generic drug from entering the market. This creates an incentive for companies to intentionally list 'sham' patents in the *Orange Book* as a way to hold off generic competition for at least 2.5 years, regardless of the outcome of any litigation.”

Warren and Jayapal’s letter urges FDA to clarify guidelines for patents that can be listed in the *Orange Book*. They note that agency regulations specify the types of patents for which manufacturers must submit information, including the drug substance (active ingredient), the drug product (formulation and composition), and method-of-use (indications). “Pharmaceutical companies regularly list patents that do not fit these categories, such as devices with no active ingredients (such as inhalers) and Risk Evaluation and Mitigation Strategies (REMS) that ensure safety through distribution requirements,” they write, adding that recent court decisions have found that listing device-only patents or REMS in the *Orange Book* is improper.

Additionally, they ask that FDA and the USPTO work together to develop a review and validation system for every patent that is listed. “The FDA does not substantively review patents submitted for listing in the *Orange Book* for correctness, and this regulatory gap hands immense power to pharmaceutical companies,” they contend. “Among the initiated USPTO-FDA collaborations, the agencies should review and validate patents together to eliminate invalid patents. Retroactively removing improperly listed patents in the *Orange Book* will help enable the earlier entry of generic competition and save resources later spent on costly patent litigation.”