FDA Seeks Input on Improving Access to Nonprescription Medications
Published Date: 12/2/2025
Notice
Summary
The FDA wants your ideas on how to make it easier for people to get nonprescription drugs, like over-the-counter medicines. They’re gathering feedback now to help plan a public meeting in 2026. If you have thoughts, send them by February 2, 2026—this could lead to faster, cheaper access for everyone!
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
NDA pathway requires consumer-use studies
If you seek to market a nonprescription drug via a new drug application (NDA) under section 505, you must submit adequate tests and substantial evidence that the drug is safe and effective for self-use. FDA often requires consumer studies—such as label comprehension, self-selection, actual use, and human factors studies—and typically requires more data when less is known about nonprescription use.
Public input open — comments due Feb 2, 2026
The FDA is asking the public—drug developers, health care providers, and consumers—to send ideas on how to increase access to nonprescription (over-the-counter) drugs. You can submit electronic or written comments that must be received by February 2, 2026; FDA will use the feedback to plan a public meeting in calendar year 2026.
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Key Dates
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