Increase the clarity and predictability of the process for developing applications for Rx-to-nonprescription switches.
- senate
- house
- president
Last progress July 30, 2025 (4 months ago)
Introduced on July 30, 2025 by Jon Husted
Sponsors (2)
House Votes
Senate Votes
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Presidential Signature
AI Summary
This bill aims to make it easier and clearer to switch some medicines from prescription-only to over-the-counter. It lets drug makers ask the FDA for planning meetings so they know what studies and evidence are needed, and requires the FDA to issue guidance within 18 months explaining the standards, what kinds of proof can be used (like medical literature or past safety findings), and how companies can show that people can choose and use the drug safely on their own. It also encourages using tools like mobile apps or decision aids to help people use these medicines correctly . Within one year, the FDA must share a public plan to work with stakeholders to spot which approved prescription drugs could be good candidates for switching to nonprescription. The bill defines both full and partial switches (some uses over-the-counter, others still by prescription) and makes clear it doesn’t change existing FDA authority over standard OTC monograph drugs or force release of trade secrets .
To track progress, a government report is due within one year after the bill becomes law. It will count how many switches were approved since October 1, 2022, how long approvals took, which partial switches were approved or not, barriers to timely review, how the FDA engaged the public, and chances to work with Medicare and Medicaid to analyze insurance data for drugs that might be good switch candidates .
- Who is affected: People who use common medicines, and companies that make them .
- What changes: Clearer FDA process with optional planning meetings; guidance on evidence and safe self-use; possible use of apps/decision aids; public plan to identify good candidates; definitions for full/partial switches; no change to OTC monograph rules; protections for trade secrets .
- When: FDA guidance within 18 months of enactment; stakeholder plan within 1 year; oversight report due 1 year after enactment, covering activity back to October 1, 2022 .