Bill · S. 2529· Senate(119-S-2529)
A bill to increase the clarity and predictability of the process for developing applications for Rx-to-nonprescription switches.
- Introduced
- 7/30/2025
- Last activity
- 7/30/2025 — Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- Sponsored by
- Jon Husted
- Cosponsors
- - 0 - 1
- Introduced
- In Committee
What this bill would do
This bill aims to increase the clarity and predictability of the process for developing applications to switch drugs from prescription to nonprescription use. It amends the Federal Food, Drug, and Cosmetic Act to allow for meetings between applicants and the Secretary to plan these applications. The Secretary is required to issue guidance regarding standards for approval, including how to use various data sources and how consumers can demonstrate they can use the drugs safely. Additionally, the Secretary must create a plan to engage with stakeholders to identify potential drug candidates for these switches. Finally, the bill mandates a report from the Comptroller General to evaluate the number of approved switches, the length of the approval process, and potential barriers to review.
Yes· 3 of 10
Would business owners be better off under this?+4
The bill provides clearer guidance and predictability for pharmaceutical companies seeking to market drugs as nonprescription.
Does this make health care easier to get in general?+4
By streamlining the process for drugs to become nonprescription, consumers gain easier access to medications without needing a doctor's visit.
Would households on low incomes be better off under this?+3
Transitioning drugs to nonprescription status may reduce the financial burden of prescription costs.
The opposite
No question was scored the opposite.
Who it would affect, and how
Potential Positive Impacts for People
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Increased Clarity in the Drug Switch Process: The bill requires the Secretary to issue guidance that describes how various data, such as medical literature and human experience, can be used to support applications for nonprescription drugs (Section 1(a)(7)(B)(i)).
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Improved Consumer Safety Information: The guidance requested by this bill will include how sponsors can demonstrate that consumers can appropriately self-select and use a drug and understand the label (Section 1(a)(7)(B)(ii)).
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Enhanced Information Tools: The bill encourages the use of mechanisms beyond the required Drug Facts Label, such as mobile applications and decision aids, to provide information for nonprescription drugs (Section 1(a)(7)(B)(ii)).
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Stakeholder Engagement: The Secretary is tasked with developing a plan to engage with stakeholders to identify drugs that may be promising candidates for the switch from prescription to nonprescription use (Section 1(a)(7)(C)).
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Increased Oversight through GAO Reporting: The Comptroller General must submit a report evaluating the number of approved applications, the time it takes for approvals, and any barriers to the review process (Section 1(b)(1)).
Potential Negative Impacts for People
- No specific negative impacts are explicitly stated in the text provided.
Groups and Interests Ranking
Every group the model scored this bill for, from -10 to +10. Hover a score for the reason it gave.
- Demographic And Interest Groups
- Good For Business Owners+4Good For Low Income Households+3Good For Middle Class Households+2Good For Retirees+2Good For Rural Residents+2Good For Seniors+2
- Healthcare
- Improves Healthcare Access+4Reduces Prescription Drug Costs+3
- Governance And Ideology
- Improves Government Transparency+3Increases Federal Power+2
- 7/30/2025
- Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- 1 Cosponsor added.
- Introduced in Senate
One bill Congress.gov lists as related to this one — companions in the other chamber, earlier versions, and bills this one absorbed or was folded into.
Maggie HassanDemocrat · New Hampshire