REMEDY Act
- Bill Number
- S. 2620
- Origin Chamber
- Senate
- Congress
- 119th Congress, Session 1
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2025-07-31: Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text: CR S5000)
- Last Updated
- 2026-07-01T16:00:43Z
AI-Generated Summary
Purpose of the Legislation
The REMEDY Act (Reforming Evergreening and Manipulation that Extends Drug Years Act) aims to prevent pharmaceutical companies from using minor patent changes—known as "evergreening"—to delay the approval of generic drugs. By limiting certain patent-related delays in the drug approval process, it seeks to speed up access to lower-cost generic medications for consumers.
Key Provisions
- Patent Selection Requirement: For drugs approved after the law's enactment, brand-name drug makers must select one specific patent (called the "covered patent") when submitting patent information to the FDA. This patent is the only one eligible for a 30-month delay in generic drug approval. The selection cannot be changed later.
- Limitation on 30-Month Stay:
- For drugs approved before enactment, the existing 30-month delay (a pause in FDA approval of generics while patent lawsuits are resolved) applies to any listed patent.
- For drugs approved after enactment, the delay applies only to the single covered patent.
- Application to Generic Drug Reviews: Similar rules apply to abbreviated new drug applications (ANDAs), which are streamlined FDA approvals for generic versions of brand-name drugs. The changes ensure the 30-month stay is restricted to the covered patent in these cases.
- Clarifying Language Updates: The bill updates wording in the Federal Food, Drug, and Cosmetic Act (FD&C Act) to specify when and how these delays apply, including during patent infringement lawsuits.
Significant Changes to Existing Law
- Under current law (Section 505 of the FD&C Act), brand-name companies can list multiple patents, potentially triggering multiple 30-month stays that delay generic entry by years.
- The REMEDY Act introduces a "one-patent-only" rule for post-enactment drugs, reducing opportunities for repeated delays. It does not retroactively change rules for already-approved drugs but applies prospectively to new approvals.
- Minor technical adjustments ensure consistency between full drug approvals (under subsection (c)) and generic approvals (under subsection (j)).
Potential Impacts
- On Government Agencies: The FDA may process generic drug applications faster by avoiding multiple litigation delays, potentially reducing backlog and workload related to patent disputes.
- On Citizens: Consumers could benefit from quicker availability of affordable generic drugs, lowering overall prescription costs and improving access to medications.
- On International Relations: No direct impact, though faster generic approvals in the U.S. might indirectly influence global drug pricing and supply chains for pharmaceuticals.
Main Stakeholders Affected
- Generic Drug Manufacturers: Benefit from reduced delays, enabling earlier market entry and competition.
- Brand-Name Pharmaceutical Companies: Face shorter exclusivity periods, potentially reducing revenue from patented drugs.
- Consumers and Patients: Gain from lower drug prices due to increased generic competition.
- FDA and Healthcare Providers: Experience streamlined approval processes, aiding in efficient drug regulation and distribution.
Notable Legal, Constitutional, or Political Implications
- Legal: The changes could lead to more patent infringement lawsuits focused on a single patent, potentially reducing court backlogs but inviting challenges from drug makers arguing it limits their intellectual property rights. It aligns with antitrust concerns over anti-competitive practices without altering core patent laws.
- Constitutional: No direct conflicts; it modifies administrative procedures under the FD&C Act, respecting due process in patent certifications.
- Political: Introduced bipartisansely (by Senators Durbin (D) and Cassidy (R)), it reflects efforts to address high drug prices amid public pressure, but may face opposition from the pharmaceutical industry lobby during committee review. Referred to the Senate Committee on Health, Education, Labor, and Pensions for further consideration.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Sen. Durbin, Richard J. [D-IL]
Cosponsors (1)
Recent Actions
- 2025-07-31: Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text: CR S5000)
- 2025-07-31: Introduced in Senate
Bill Versions
- Reforming Evergreening and Manipulation that Extends Drug Years Act — issued 2025-07-31 — PDF (6 pages)