Jon Husted (R-OH)
A bill to increase the clarity and predictability of the process for developing applications for Rx-to-nonprescription switches.
A Republican bill with 1 Democratic cosponsor · See the cosponsor
Last activity — Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
In committee
Introduced and handed to a committee in the chamber it started in.
The committee holds it, and most bills are never heard from again. A hearing or a committee vote would be news; silence is the usual outcome, and it kills the bill without anyone voting against it.
Its path through Congress
- 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
- Scored +4
Would business owners be better off under this?
The bill provides clearer guidance and predictability for pharmaceutical companies seeking to market drugs as nonprescription.
- Scored +4
Does this make health care easier to get in general?
By streamlining the process for drugs to become nonprescription, consumers gain easier access to medications without needing a doctor's visit.
- Scored +3
Would households on low incomes be better off under this?
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. Tap or hover a score for the reason it gave.
- Demographic And Interest Groups
- Would business owners be better off under this? — The bill provides clearer guidance and predictability for pharmaceutical companies seeking to market drugs as nonprescription. Would households on low incomes be better off under this? — Transitioning drugs to nonprescription status may reduce the financial burden of prescription costs. Would middle-income households be better off under this? — Increased availability of nonprescription options can provide cost savings for families. Would retired people be better off under this? — The ability to self-manage health with nonprescription drugs can assist retirees in managing chronic conditions. Would people in rural areas be better off under this? — Easier access to nonprescription drugs may benefit those in rural areas with limited access to medical providers. Would people over 65 be better off under this? — Increased access to nonprescription medications may benefit seniors managing common health conditions.
- Healthcare
- Does this make health care easier to get in general? — By streamlining the process for drugs to become nonprescription, consumers gain easier access to medications without needing a doctor's visit. Does this lower the price of prescription medicines? — The bill facilitates the transition of drugs from prescription to nonprescription status, which can lower costs for consumers.
- Governance And Ideology
- Does this make what the government does easier for the public to see? — The bill mandates the publication of a stakeholder engagement plan and a GAO report on the drug switch process. Does this give the federal government more power? — The bill clarifies the authority and responsibilities of the Secretary of HHS and the FDA in the drug approval process.
- 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