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
Floor votes
How they voted
No floor votes recorded yet.
Full legislative history
Actions timeline
Total actions
2
Key actions
0
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
Greg Landsman
DDemocratic
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