Sponsor
Greg Landsman
Representative · D-OH
Representative · D-OH
The bill seeks to speed and clarify OTC switch pathways through required FDA-requestor meetings and a 'least burdensome' review standard, trading faster access and greater procedural transparency for increased safety risk, potential resource strain at FDA, and advantages for better-funded firms.
Patients (especially those with chronic conditions) and general OTC consumers could get faster access to certain drugs because FDA must use the least-burdensome appropriate means when evaluating GRASE (OTC switch) requests.
Drug sponsors, hospitals, and health systems gain clearer, more predictable pre-submission guidance and greater administrative transparency because FDA must meet with requestors, provide recommendations on evidence and study design, record meeting minutes, and include those recommendations and summaries in the administrative record.
All OTC consumers (including chronic patients) face higher risk that unsafe or ineffective products reach the market because a 'least-burdensome' evidentiary standard could lower the amount/rigor of data required for OTC switches.
FDA and taxpayers could incur greater workload and costs because increased required meetings and documentation may divert agency resources, slow other regulatory reviews, or create administrative burdens.
Small businesses and less-resourced developers could be disadvantaged because greater pre-submission interaction and meetings may favor firms that can better prepare for and pay for frequent engagement with FDA.
Based on analysis of 2 sections of legislative text.
Requires FDA to use least‑burdensome review and offer meetings/recommendations when reviewing requests to deem OTC monograph drugs GRASE, and to include meeting records in the administrative record.
Official title: To amend the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services to apply the least burdensome appropriate means for supporting certain administrative order requests with respect to over-the-counter monograph drugs, and for other purposes.
Introduced December 18, 2025 by Greg Landsman · Last progress December 18, 2025
Requires the Food and Drug Administration to apply the “least burdensome appropriate means” when reviewing requests to find an over‑the‑counter (OTC) monograph drug generally recognized as safe and effective (GRASE). If published evidence is insufficient, the FDA must meet with a requester who asks in writing, give recommendations on evidence and study design/size as appropriate, prepare meeting minutes, and place the recommendations and meeting summary in the administrative record, while preserving existing GRASE standards and completeness requirements.