Nonprescription Analgesic/Antipyretic Drug Development in Children 2 to Less Than 12 Years of Age - 11/15/2024

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Organized By

CDER Office of New Drugs, M-CERSI

Registration

TBA

Summary

The Food and Drug Administration is announcing the following public workshop entitled "Nonprescription Analgesic/Antipyretic Drug Development in Children 2 to Less Than 12 Years of Age." Presently, marketed nonprescription drug products for pain (analgesics) and fever (antipyretics) for children 2 to less than 12 years of age are primarily limited to drug products containing acetaminophen or a nonsteroidal anti-inflammatory drug (NSAID), such as ibuprofen as active ingredients. These pediatric products are indicated for the temporary relief of minor aches and pains due to the common cold, sore throat, flu, headache, toothache, and fever reduction. New acetaminophen and NSAID-containing drug products may offer different characteristics than that of currently available products. However, it is unclear if there are pediatric subpopulations in children 2 to less than 12 years of age who may benefit from new acetaminophen and NSAID-containing drug products. Additionally, there is ambiguity regarding the extent to which expanding the nonprescription analgesic/antipyretic treatment options for this age group might lead to consumer confusion, considering the availability of multiple products containing similar ingredients for the same indication.

Objective

The goal of the workshop is to discuss the current nonprescription analgesic/antipyretic treatment options available for children 2 to less than 12 years of age and the development needs for additional oral nonprescription treatment options containing acetaminophen and/or NSAIDs for pain, fever, or both for the same pediatric population.

Topics for Discussion

The topics we will be exploring are:

• the necessity for developing new nonprescription analgesics and antipyretics containing acetaminophen or NSAIDs, either alone or in combination to reduce pain and fever,
• drug characteristics that represent a therapeutic benefit over current treatment options
• the pediatric subpopulations (e.g., age groups) that would benefit from these new nonprescription drugs for the already established labeled uses (for temporary relief for minor aches and pains due to the common cold, sore throat, flu, headache, toothache, fever reduction)
• the potential unintended consequences of introducing more products containing similar ingredients for the same indication in this age group, particularly in relation to consumer confusion

Agenda

Please check back for an updated agenda.

Visiting the FDA Campus (If held at FDA Campus)

Entrance for the public workshop participants (non-FDA employees) is through Building 1, where routine security check procedures will be performed. For parking and security information, please refer to Public Meeting Information, Getting to the FDA, and Visitor Parking and Campus Map.

Virtual Attendance Information

This meeting will be hybrid. The Zoom link will be provided to all registered attendees in a calendar invite the before the meeting.

Food & Drink

Refreshments and sandwiches are available for purchase. Attendees may bring their own food and drink; however, the FDA cannot guarantee the use of a refrigerator or microwave. Restaurants near the FDA White Oak campus are available, but before leaving, meeting attendees should consider the amount of time needed to return to campus and go through security screening.

Accessibility

The FDA will make every effort to accommodate persons with physical disabilities or special needs at public meetings. If you require accommodations due to a disability, email ONDPublicMTGSupport@fda.hhs.gov at least 14 days before a public meeting. The FDA White Oak campus and FDA shuttle are generally accessible to people with physical disabilities.

Contact

For additional details, contact the FDAs CDER/OND/Public Meeting Support Team at ONDPublicMTGSupport@fda.hhs.gov.