Federal RuleAug 21
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DOL Rewrites Disability Rules for 'Merit-Based Opportunity' Push
RuleLabor DepartmentFederal Contract Compliance Programs OfficeSignificant Wallet
119-s-2529119th CongressWALLET
A bill to increase the clarity and predictability of the process for developing applications for Rx-to-nonprescription switches.
Sponsored By: Senator Husted, Jon [R-OH]
Introduced
Summary
A clear, predictable pathway for switching prescription drugs to nonprescription status. The bill would authorize meetings between drug sponsors and the FDA to map studies and safety steps. It would require FDA guidance within 18 months, a public stakeholder engagement plan within 1 year, and a GAO review of switch outcomes and barriers within 1 year.
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Bill Overview
Analyzed Economic Effects
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
Clearer rules for prescription-to-OTC switches
If enacted, this bill would require the FDA Secretary to publish guidance within 18 months to make Rx-to-nonprescription switch reviews clearer. It would let people planning a switch ask the FDA in writing for meetings to plan safety steps and study designs. Each meeting would have minutes recorded. The FDA would also post a public stakeholder engagement plan within one year about how to identify good switch candidates. The bill would not change FDA authority over OTC monograph drugs or let the FDA disclose trade secrets.
Sponsors & CoSponsors
Sponsor
Husted, Jon [R-OH]
OH • R
Cosponsors
Sen. Hassan, Margaret Wood [D-NH]
NH • D
Sponsored 7/30/2025
Roll Call Votes
No roll call votes available for this bill.
View on Congress.gov