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Extending OTC Drug Fees and Streamlining Non-Prescription Drug Approvals until 2030.

This law extends the user fee program for Over-the-Counter (OTC) drug manufacturers until 2030, ensuring continued FDA oversight and funding for non-prescription drug safety. It introduces clearer rules for converting prescription drugs to OTC status, potentially increasing consumer access to certain medications. Furthermore, it mandates the use of modern testing standards and real-world evidence for topical drugs, aiming to enhance the quality and safety of products like sunscreens.
Key points
Streamlining the process for switching prescription drugs to non-prescription status (Rx-to-OTC), potentially increasing consumer access to certain medications.
Implementing new quality and testing standards for topical drugs (e.g., sunscreens), including the use of real-world evidence and alternatives to animal testing.
Extending FDA funding through fees paid by OTC drug manufacturers until 2030 to maintain continuous safety oversight of these products.
Increased transparency: FDA must publicly release detailed minutes of negotiation meetings with the regulated industry.
article Official text account_balance Process page
Placed on Calendar
Citizen Poll
No votes cast
Additional Information
Print number: 119_S_2292
Sponsor: Sen. Banks, Jim [R-IN]
Process start date: 2025-07-15
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Summarized by: gemini-flash-latest
Source data: api.congress.gov
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OFFICIAL LEGAL TITLE

Over-the-Counter Monograph Drug User Fee Amendments

FREQUENTLY ASKED QUESTIONS

What is the official ID of this bill?

The official print number for this legislation is 119_S_2292.

Which chamber initiated this legislation?

This legislation was initiated in the Senate.

When did the legislative process begin?

The process officially started on 2025-07-15.

What are the main provisions?

Key points include:

  • Streamlining the process for switching prescription drugs to non-prescription status (Rx-to-OTC), potentially increasing consumer access to certain medications.
  • Implementing new quality and testing standards for topical drugs (e.g., sunscreens), including the use of real-world evidence and alternatives to animal testing.
  • Extending FDA funding through fees paid by OTC drug manufacturers until 2030 to maintain continuous safety oversight of these products.
  • Increased transparency: FDA must publicly release detailed minutes of negotiation meetings with the regulated industry.
What is the specific legal status?

The current status is Placed on Calendar.

Where can I read the full text of this legislation?

The full official text is available at: View full text

Who is the primary sponsor?

The primary sponsor is Sen. Banks, Jim [R-IN].

What is the latest detailed status?

The latest detailed status is: Placed on Senate Legislative Calendar under General Orders. Calendar No. 152.

Is this summary verified?

Yes. This content was analyzed by AI and verified by the Lustra Judge System on 2025-12-31.

CATEGORIES

Health