To amend the Federal Food, Drug, and Cosmetic Act to provide for expedited approval of priority nonprescription drugs, and for other purposes.
Sponsored By: Representative Latta, Robert E. [R-OH-5]
Introduced
Summary
This bill would create a new __priority nonprescription drug designation__ to speed development and FDA review of drugs switching from prescription to over-the-counter use. It targets novel nonprescription uses and products that could offer meaningful public health benefits.
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Bill Overview
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
Keeps current OTC safety rules
This bill would say the new priority designation does not change the evidence or data needed to approve nonprescription drugs under current FDA rules. That would keep existing testing and safety standards for over-the-counter medicines in place. This would take effect upon enactment.
Fast-track some over-the-counter drugs
This bill would let a drug sponsor ask HHS to designate a medicine as a priority nonprescription drug when seeking FDA approval to sell it without a prescription. HHS would have 60 calendar days to decide. If designated, HHS would give extra meetings, timely advice, a cross-disciplinary project lead, senior reviewer involvement, and steps to speed trials, including using real-world evidence when appropriate. Drugs subject to a REMS safety plan or that are controlled substances would not be eligible. HHS would publish a list of conditions within 18 months and take at least 30 days of public comment. The designation authority would end on September 30, 2032, and HHS would report to Congress within four years.
Sponsors & CoSponsors
Sponsor
Latta, Robert E. [R-OH-5]
OH • R
Cosponsors
Rep. Landsman, Greg [D-OH-1]
OH • D
Sponsored 7/20/2026
Roll Call Votes
No roll call votes available for this bill.
View on Congress.gov