Bill · H.R. 6868· House(119-HR-6868)
ACCESS Through OTC Innovation Act
- Introduced
- 12/18/2025
- Last activity
- 12/18/2025 — Referred to the House Committee on Energy and Commerce.
- Sponsored by
- Greg Landsman
- Cosponsors
- None
- Introduced
- In Committee
What this bill would do
This bill, known as the "ACCESS Through OTC Innovation Act," seeks to amend the Federal Food, Drug, and Cosmetic Act. It directs the Secretary of Health and Human Services to use the least burdensome appropriate means when supporting certain administrative order requests for over-the-counter monograph drugs. The legislation requires the Secretary to meet with requestors to provide recommendations on necessary evidence, such as study design and size, if published reports are insufficient. Additionally, the Secretary must prepare meeting minutes and include study recommendations and discussion summaries in the administrative record.
Yes· 3 of 6
Would business owners be better off under this?+4
The mandate for the Secretary to use the least burdensome means provides a more predictable and efficient path for drug manufacturers.
Does this make it easier to run a small business?+3
The bill reduces the regulatory burden on companies seeking to update over-the-counter drug monographs through streamlined administrative processes.
Does this make what the government does easier for the public to see?+3
The bill requires the Secretary to maintain meeting minutes and include study recommendations in the public administrative record.
The opposite
No question was scored the opposite.
Who it would affect, and how
Potential Positive Impacts for People
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Reduced Burden for Drug Requests: The Secretary is directed to apply the least burdensome appropriate means for supporting administrative order requests regarding over-the-counter monograph drugs (Section 2, subsection q(1)).
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Guidance on Evidence Requirements: If published reports are insufficient, the Secretary shall meet with requestors to provide recommendations on necessary evidence, including potential study designs and sizes (Section 2, subsection q(2)(A)).
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Increased Transparency through Documentation: The Secretary is required to prepare and make available meeting minutes to the requestor, and must include study recommendations and meeting summaries in the administrative record (Section 2, subsection q(2)(B) and (C)).
Potential Negative Impacts for People
- No specific negative impacts are explicitly stated in the provided text.
Groups and Interests Ranking
Every group the model scored this bill for, from -10 to +10. Hover a score for the reason it gave.
- Demographic And Interest Groups
- Good For Business Owners+4Good For Low Income Households+1
- Healthcare
- Improves Healthcare Access+2Reduces Prescription Drug Costs+2
- Economy And Finance
- Improves Small Business Support+3
- Governance And Ideology
- Improves Government Transparency+3
- 12/18/2025
- Referred to the House Committee on Energy and Commerce.
- Introduced in House