OTC Monograph Drug User Fee Transparency Act | ChamberLight
Bills · S 2513
IN COMMITTEE· 119TH CONGRESS
Senate BillS 2513Health
OTC Monograph Drug User Fee Transparency Act
INTRO JUL 29· LAST ACTION JUL 29
READING
5MIN
COSPONSORS
0
READER REACTIONS0 TOTAL
NO VOTES YET · BE THE FIRST
Introduced only
LEGISLATIVE PROGRESS
STEP 2 / 8
Introduced
In Committee
Reported
Passed Senate
Passed House
Conference
To President
Became Law
WHAT THE BILL DOES
AI-written
This bill matters because it aims to make the process of getting over-the-counter drugs to market more transparent and efficient, which could lead to new or improved products becoming available sooner. Currently, many people rely on common OTC medications for everyday ailments, and understanding how these drugs are approved and monitored is important for public trust and safety. If this bill becomes law, the public will gain a clearer picture of the FDA's performance in reviewing drug applications and its efforts to ensure drug safety after products are on shelves.
Furthermore, the bill addresses concerns about the stability of the supply chain for essential OTC medicines. By requiring a comprehensive study, it seeks to identify potential weaknesses and inform future policies to prevent shortages, a real issue that can impact people's ability to get the medicines they need. Without this bill, the current level of public reporting and insight into the FDA's OTC drug review process and the overall supply chain would remain unchanged, potentially leaving consumers less informed and the supply chain less understood.
KEY PROVISIONS
4AI-extracted
PROVISION 01
Requires the FDA to include detailed information in its annual reports, starting in fiscal year 2026, about how it processes different types of over-the-counter drug applications and the average time it takes.
This provides public insight into the FDA's efficiency and responsiveness in bringing new or updated OTC drugs to market.
PROVISION 02
Mandates that the FDA include information in its annual reports about postmarket safety activities for over-the-counter drugs, including collecting and reviewing safety data and using improved analytical tools.
This ensures the public is aware of how the FDA monitors the safety of OTC drugs once they are available for purchase.
PROVISION 03
Requires the FDA to make public detailed written minutes of negotiation meetings with the regulated industry, including substantive proposals and disagreements, within 30 days of the meeting.
This increases transparency in how the FDA interacts with drug manufacturers during the regulatory process.
PROVISION 04
Directs the Government Accountability Office (GAO) to conduct a report within two years on the supply chain of over-the-counter monograph drugs.
This will provide an independent assessment of the stability of the OTC drug supply and how the FDA manages it, which could help prevent shortages.
This bill matters because it aims to make the process of getting over-the-counter drugs to market more transparent and efficient, which could lead to new or improved products becoming available sooner. Currently, many people rely on common OTC medications for everyday ailments, and understanding how these drugs are approved and monitored is important for public trust and safety. If this bill becomes law, the public will gain a clearer picture of the FDA's performance in reviewing drug applications and its efforts to ensure drug safety after products are on shelves.
Furthermore, the bill addresses concerns about the stability of the supply chain for essential OTC medicines. By requiring a comprehensive study, it seeks to identify potential weaknesses and inform future policies to prevent shortages, a real issue that can impact people's ability to get the medicines they need. Without this bill, the current level of public reporting and insight into the FDA's OTC drug review process and the overall supply chain would remain unchanged, potentially leaving consumers less informed and the supply chain less understood.
KEY PROVISIONS
AI-extracted
high
Requires the FDA to include detailed information in its annual reports, starting in fiscal year 2026, about how it processes different types of over-the-counter drug applications and the average time it takes.
This provides public insight into the FDA's efficiency and responsiveness in bringing new or updated OTC drugs to market.
high
Mandates that the FDA include information in its annual reports about postmarket safety activities for over-the-counter drugs, including collecting and reviewing safety data and using improved analytical tools.
This ensures the public is aware of how the FDA monitors the safety of OTC drugs once they are available for purchase.
med
Requires the FDA to make public detailed written minutes of negotiation meetings with the regulated industry, including substantive proposals and disagreements, within 30 days of the meeting.
This increases transparency in how the FDA interacts with drug manufacturers during the regulatory process.
high
Directs the Government Accountability Office (GAO) to conduct a report within two years on the supply chain of over-the-counter monograph drugs.
This will provide an independent assessment of the stability of the OTC drug supply and how the FDA manages it, which could help prevent shortages.
FDA's expanded annual performance reports begin, including additional specific information.
Not later than 2 years after the date of enactment
Comptroller General (GAO) to submit a report assessing the supply chain of over-the-counter monograph drugs to Congress.
Not later than 30 days after each such negotiation meeting
FDA must make publicly available robust written minutes of all negotiation meetings.
GLOSSARY
AI-written
Federal Food, Drug, and Cosmetic Act
The main law that gives the FDA authority to oversee the safety of food, drugs, medical devices, and cosmetics in the U.S.
OTC Monograph Drug
An over-the-counter drug (meaning you don't need a prescription) that is recognized as safe and effective by the FDA through a public rulebook (monograph) rather than individual drug approvals.
User Fee
A fee paid by drug manufacturers to the FDA to help fund the review and approval processes for their products.
Monograph Order Request
A formal request to the FDA from a drug manufacturer to make changes to an existing OTC monograph, such as adding new ingredients or uses, or to finalize a preliminary monograph.
Tier 1/Tier 2 OTC Monograph Order Requests
Categories of OTC drug application requests, likely indicating different levels of complexity or impact on public health, with Tier 1 generally being more significant.
Postmarket Safety Activities
Actions taken by the FDA to monitor the safety of drugs after they have been approved and are available to the public, including collecting adverse event reports.
Government Accountability Office (GAO)
ACTION TIMELINE
2 EVENTS
JUL 29, 25
Introduced in Senate
INTROREFERRAL
JUL 29, 25
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
An independent agency that works for Congress, often called the 'congressional watchdog,' that investigates how the federal government spends taxpayer dollars.
Supply Chain
The entire process of making and getting a product from its raw materials to the final consumer, including manufacturing, transportation, and distribution.
