HR 6868 United States House · 119th Congress

ACCESS Through OTC Innovation Act

This bill (HR 6868) streamlines the FDA review process for over-the-counter (OTC) drugs by requiring the agency to use the "least burdensome" approach when evaluating manufacturer requests to add new products to standardized OTC safety guidelines. It mandates that the FDA meet with companies if existing data is insufficient, provide written recommendations for necessary studies, and document these meetings in the public administrative record. The bill directly affects drug manufacturers seeking to market new OTC products, reducing review barriers without changing safety standards or altering the criteria for FDA approval. This focuses on improving efficiency in the regulatory process for OTC drug innovations.
Bill status in committee 1 of 4 stages cleared
Introduction
Dec 2025
Committee Review
Floor Vote
President
Introduced Dec 18, 2025 Last action Dec 18, 2025
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Full legislative history

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Committee
1
Dec 18, 2025
Committee
Referred to the House Committee on Energy and Commerce.
lower
Dec 18, 2025
Introduced
Introduced in House
lower
1 primary · 0 co-sponsors

Sponsors

Role
Legislator
Party
State
District
P
Photo of Greg Landsman
Greg Landsman
DDemocratic
OH
1