ACCESS Through OTC Innovation Act
Summary
What This Bill Does
The bill amends section 505G of the Federal Food, Drug, and Cosmetic Act for over-the-counter monograph drugs. When FDA evaluates a request to recognize an OTC drug as generally recognized as safe and effective, it must use the least burdensome appropriate means that still satisfies the statute. If published reports are not enough, FDA must meet with the requestor on reasonable written request, recommend evidence such as study design and size, prepare meeting minutes, and put recommendations and meeting summaries in the administrative record. The bill preserves the existing completeness and GRASE criteria.
Who Benefits and How
OTC drug sponsors, pharmaceutical manufacturers, and consumers seeking new nonprescription options benefit because sponsors get earlier FDA feedback and a lower-burden evidence pathway before paying for studies.
Who Bears the Burden and How
FDA monograph review staff must comply with the least-burdensome standard, hold requested meetings, prepare minutes, document study recommendations, and maintain an administrative record for each covered request.
Key Provisions
- Requires FDA to apply the least burdensome appropriate means for covered OTC monograph order requests.
- Requires FDA meetings with requestors when published reports are insufficient to support GRASE findings.
- Requires FDA to prepare minutes and place evidence recommendations in the administrative record.
Evidence Chain:
This summary is generated from the full bill text using AI analysis. Expand "Detailed Analysis" below for identified beneficiaries/burden bearers with clause-level evidence links.
At a Glance
What This Bill Does
Requires FDA to use the least burdensome appropriate evidence approach when evaluating certain over-the-counter monograph drug administrative-order requests and to meet with requestors when published reports are insufficient.
Key Policy Areas
Healthcare, Pharmaceuticals, Consumers, Government
Primary Purpose
Requires FDA to use the least burdensome appropriate evidence approach when evaluating certain over-the-counter monograph drug administrative-order requests and to meet with requestors when published reports are insufficient.
Policy Domains
Substantive provisions
Identified Gains
- OTC drug sponsors
- Pharmaceutical manufacturers
- Consumers seeking nonprescription medicines
Identified Costs
- FDA monograph review staff
- FDA administrative record staff
Sponsors
Legislative Progress
In CommitteeMr. Landsman introduced the following bill; which was referred to …
Referred to the House Committee on Energy and Commerce.
Introduced in House
Stakeholder Effects
cui bono?How this legislation distributes effects. Mention counts reflect frequency, not effect magnitude.
OTC drug sponsors, Pharmaceutical manufacturers
FDA administrative record staff, FDA monograph review staff
Bill Structure & Actor Mappings
Who is "The Secretary" in each section?
We use a combination of our own taxonomy and classification in addition to large language models to assess meaning and potential beneficiaries. High confidence means strong textual evidence. Always verify with the original bill text.
Learn more about our methodology