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S. 4878

BillFederalSenateIn Committee
To amend the Federal Food, Drug, and Cosmetic Act with respect to approval of abbreviated new drug applications.
About This Bill
Committee
Latest Action · July 31, 2024
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text: CR S5684-5685)
Congress
118th (2023–2025)
Introduced
July 31, 2024
Cosponsors (1)
0D 1R
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Summary

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The REMEDY Act aims to curb "evergreening," a practice where pharmaceutical companies repeatedly file patents on minor drug modifications to extend their monopolies and delay cheaper generic alternatives. The bill amends federal drug approval rules by requiring drug manufacturers to designate a single "covered patent" for any new drugs approved after the law's enactment, limiting the company's ability to use multiple patents to trigger 30-month delays on generic drug approvals. This change primarily affects pharmaceutical companies and generic drug manufacturers, as it restricts the tools available to brand-name drugmakers to delay generic competition. The legislation does not include specific funding provisions, as it is a regulatory reform that modifies patent procedures rather than a spending measure. The restrictions apply only to drugs approved on or after the bill's enactment date, leaving existing drug patents under current rules.

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