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.
Status:
Placed on Calendar
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