A bill to increase the clarity and predictability of the process for developing applications for Rx-to-nonprescription switches.
- Bill Number
- S. 2529
- Origin Chamber
- Senate
- Congress
- 119th Congress, Session 1
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2025-07-30: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- Last Updated
- 2026-05-07T13:52:15Z
AI-Generated Summary
Purpose
This legislation amends the Federal Food, Drug, and Cosmetic Act to improve the clarity and predictability of the FDA's review process for applications seeking to switch prescription drugs to nonprescription (over-the-counter) status, known as Rx-to-nonprescription switches. It aims to support safer and more efficient transitions while addressing public health risks.
Key Provisions
- Meetings with FDA: Sponsors planning an Rx-to-nonprescription switch application may request a meeting to discuss risks, evidence needs, study designs, and application format; meetings must be documented in minutes.
- FDA Guidance: The Secretary must issue guidance within 18 months on approval standards for nonprescription drugs, including switches, covering use of literature, prior findings, human experience data, self-selection and labeling comprehension by consumers, and tools like mobile apps or decision aids.
- Stakeholder Engagement Plan: Within 1 year, the FDA must create and publish a plan for engaging stakeholders on identifying promising candidates for switches.
- Definitions: Clarifies "Rx-to-nonprescription switch" as including full switches (entire drug moves to nonprescription use, possibly with added conditions) and partial switches (drug available both ways under different conditions).
- GAO Report: The Comptroller General must submit a report within 1 year evaluating approved switches since October 2022, review timelines, barriers, stakeholder engagement, and collaboration opportunities with CMS on claims data.
- Rule of Construction: Preserves existing authority over OTC monograph drugs and protects confidential commercial information.
Significant Changes to Existing Law
The bill adds a new paragraph (7) to Section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)), introducing structured meeting requests, mandatory guidance, and a stakeholder plan specifically for Rx-to-nonprescription switches. It does not alter core approval standards but formalizes procedural support.
Potential Impacts
- Government Agencies: Increases FDA workload for meetings, guidance development, and stakeholder outreach; requires GAO to analyze switch data and review processes.
- Citizens: May lead to more predictable pathways for consumers to access certain medications without prescriptions, potentially improving access while emphasizing label comprehension and self-use safety.
- International Relations: No direct effects noted.
Main Stakeholders Affected
- Pharmaceutical sponsors and application holders seeking switches.
- FDA (Center for Drug Evaluation and Research).
- Consumers and public health advocates.
- Congressional committees (Senate HELP and House Energy and Commerce).
- GAO for oversight reporting.
- Potentially CMS for data collaboration.
Notable Legal, Constitutional, or Political Implications
The legislation enhances regulatory transparency without changing statutory authority or disclosing trade secrets, maintaining FDA discretion in meetings and approvals. It focuses on procedural improvements rather than new substantive requirements, with no apparent constitutional conflicts.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Cosponsors (1)
Sen. Hassan, Margaret Wood [D-NH]
Recent Actions
- 2025-07-30: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- 2025-07-30: Introduced in Senate
Bill Versions
- To increase the clarity and predictability of the process for developing applications for Rx-to-nonprescription switches. — issued 2025-07-30 — PDF (8 pages)