To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user fee program for over-the-counter monograph drugs, and for other purposes.
Sponsors
Legislative Progress
ReportedReported by Mr. Cassidy, with an amendment
Mr. Banks (for himself, Mr. Kaine, Mr. Kim, and Mr. …
Mr. Banks (for himself and Mr. Kaine) introduced the following …
Summary
What This Bill Does
Extends the OTC monograph drug user fee program and expands definition of OTC monograph order requests to include voluntary consensus testing standards. Funds FDA OTC drug review activities.
Who Benefits and How
- FDA receives continued user fee funding for OTC drug activities
- OTC drug manufacturers benefit from clear standards and predictable fees
- Consumers gain from continued FDA oversight of OTC medications
Who Bears the Burden and How
- OTC drug industry pays user fees to fund FDA activities
- FDA must meet performance goals in user fee agreement
Key Provisions
- Extends OTC monograph drug user fee authorization
- Adds testing procedure modifications as OTC monograph order requests
- Incorporates voluntary consensus standards from recognized organizations
- References FDA guidance on pharmaceutical quality standards
Evidence Chain:
This summary is derived from the structured analysis below. See "Detailed Analysis" for per-title beneficiaries/burden bearers with clause-level evidence links.
Primary Purpose
Reauthorizes and amends user fee program for over-the-counter monograph drugs
Policy Domains
Legislative Strategy
"Continue FDA OTC drug oversight through industry user fees"
Bill Structure & Actor Mappings
Who is "The Secretary" in each section?
- "the_secretary"
- → Secretary of HHS
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