Over-the-Counter Monograph Drug User Fee Amendments
Summary
What This Bill Does
The bill creates congressional finding that fees authorized by this Act will be dedicated to OTC monograph drug activities per goals set forth in FDA-Congress correspondence, amends OTC monograph drug definitions to include voluntary consensus standards for pharmaceutical quality testing procedures established by national or international standards organizations, and defines modifies OTC monograph fee assessment periods, specifying different applicable periods for fiscal years 2026-2030. It relies on definition changes, reporting requirements, compliance mandates, and appropriations. The main policy areas are Healthcare and Trade.
Who Benefits and How
FDA could gain revenue opportunities, OTC drug manufacturers could face lower compliance burdens, and Topical OTC drug manufacturers could face lower compliance burdens.
Who Bears the Burden and How
OTC drug facility operators would take on compliance duties, FDA Center for Drug Evaluation and Research would take on compliance duties, and Pharmaceutical companies seeking FDA approval would take on compliance duties.
Key Provisions
- Creates congressional finding that fees authorized by this Act will be dedicated to OTC monograph drug activities per goals set forth in FDA-Congress correspondence.
- Amends OTC monograph drug definitions to include voluntary consensus standards for pharmaceutical quality testing procedures established by national or international standards organizations.
- Defines modifies OTC monograph fee assessment periods, specifying different applicable periods for fiscal years 2026-2030.
- Requires amendment to reporting requirements for FDA drug approval process.
- Creates preserves existing OTC monograph fee authority for fiscal years prior to 2026 notwithstanding amendments made by this Act.
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
The bill creates congressional finding that fees authorized by this Act will be dedicated to OTC monograph drug activities per goals set forth in FDA-Congress correspondence, amends OTC monograph drug definitions to include voluntary consensus standards for pharmaceutical quality testing procedures established by national or international standards organizations, and defines modifies OTC monograph fee assessment periods, specifying different applicable periods for fiscal years 2026-2030.
Key Policy Areas
Healthcare, Trade
Primary Purpose
The bill creates congressional finding that fees authorized by this Act will be dedicated to OTC monograph drug activities per goals set forth in FDA-Congress correspondence, amends OTC monograph drug definitions to include voluntary consensus standards for pharmaceutical quality testing procedures established by national or international standards organizations, and defines modifies OTC monograph fee assessment periods, specifying different applicable periods for fiscal years 2026-2030.
Policy Domains
Whole bill
Identified Gains
- FDA
- OTC drug manufacturers
- Topical OTC drug manufacturers
- Pharmaceutical companies seeking Rx-to-OTC switches
- Standards organizations (USP, ISO)
Identified Costs
- OTC drug facility operators
- FDA Center for Drug Evaluation and Research
- Pharmaceutical companies seeking FDA approval
- Pharmaceutical companies and drug manufacturers
- FDA
Sponsors
Legislative Progress
ReportedReported by Mr. Cassidy, with an amendment
Placed on Senate Legislative Calendar under General Orders. Calendar No. …
Committee on Health, Education, Labor, and Pensions. Reported by Senator …
Committee on Health, Education, Labor, and Pensions. Ordered to be …
Introduced in Senate
Mr. Banks (for himself and Mr. Kaine) introduced the following …
Read twice and referred to the Committee on Health, Education, …
Mr. Banks (for himself, Mr. Kaine, Mr. Kim, and Mr. …
Stakeholder Effects
cui bono?How this legislation distributes effects. Mention counts reflect frequency, not effect magnitude.
Congress (oversight), FDA, FDA Center for Drug Evaluation and Research
FDA faces effects in multiple directions
Positive-direction: Congress (oversight)
Negative-direction: FDA Center for Drug Evaluation and Research
OTC drug facility operators, OTC drug manufacturers, Pharmaceutical companies seeking Rx-to-OTC switches
Positive-direction: OTC drug manufacturers, Pharmaceutical companies seeking Rx-to-OTC switches, Topical OTC drug manufacturers
Negative-direction: OTC drug facility operators
Pharmaceutical companies and drug manufacturers, Pharmaceutical companies seeking FDA approval
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