About This Event
This public workshop will be hosted by the FDA/CDER Office of New Drugs in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI). 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 nonsteroidal anti-inflammatory drugs (NSAIDs) for pain, fever, or both for the same pediatric population.
Background
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. Additional acetaminophen and NSAID-containing drug products may offer different product 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 additional acetaminophen and NSAID-containing drug products. Moreover, 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.
Discussion Topics
The topics we will be exploring are:
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the necessity for developing additional nonprescription analgesics and antipyretics containing acetaminophen or NSAIDs, either alone or in combination to reduce pain and fever.
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the drug characteristics that would represent a therapeutic benefit over current treatment options.
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the pediatric subpopulations (e.g., age groups) that would benefit from these additional 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).
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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.
FDA-University of Maryland CERSI Public Workshop:
NonprescriptionAnalgesic/Antipyretic Drug Development in Children 2 to Less Than 12 Years of Age
Friday, November 15, 2024 (9:00 a.m. -4:00 p.m.)
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Welcome and Session 1: Current Perspectives on Consumer Use of Nonprescription Pain and Fever Products and Potential Unmet Needs (Video Recordings)
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| 9:00 a.m. - 9:10 a.m. |
Welcome and Opening Remarks
Nushin Todd, Director, Division of Nonprescription Drugs 1 (DNPD1) U.S. Food and Drug Administration (FDA)
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| 9:10 a.m. - 9:20 a.m. |
Introductory Remarks
Theresa Michele, Director, Office of Nonprescription Drugs, FDA
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| 9:20 a.m. - 9:35 a.m. |
Regulatory Background for Children’s Nonprescription Pain and Fever Products
Shila Azodi, Medical Officer, DNPD1, FDA
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Presentation
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| 9:35 a.m. - 9:45 a.m. |
Pediatric Research Equity Act (PREA)
Ndidi Nwokorie, Medical Officer, Division of Pediatrics and Maternal Health (DPMH), FDA
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Presentation |
| 9:45 a.m. - 10:00 a.m. |
Clinical Considerations for OTC Antipyretic-Analgesics Among 2–12-Year-Old Children
Ian Paul, University Professor of Pediatrics, Pediatrician, Penn State College of Medicine
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Presentation |
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| 10:00 a.m. - 10:15 a.m. |
Current Perspectives on Consumer Use of Nonprescription Pain and Fever Products and Potential Unmet Needs: Epidemiology of Symptoms
Diane Hindman, Attending Physician, University of Arizona College of Medicine
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Presentation
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| 10:15 a.m. - 10:30 a.m. |
Collaboration Leads to Improved OTC Solutions for Children
Leanne West, President, International Children’s Advisory Network
Casey Cashman, Director, Pediatric Pain Warrior, U.S. Pain Foundation
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Presentation
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| 10:30 a.m. - 10:45 a.m. |
Patient Perspectives: Case Study Series
Jody Thomas, Founder/CEO, Meg Foundation
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Presentation |
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10:45 a.m. - 11:00 a.m.
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The National Consumers League
Sally Greenberg, Chief Executive Officer, National Consumers League
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Presentation
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| 11:00 a.m. - 11:15 a.m. |
Break
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| 11:15 a.m. - 12:15 p.m. |
Panel Discussion Moderators:
Aklil Getachew, Medical Officer, DNPD1, FDA
Ndidi Nwokorie, Medical Officer, DPMH, FDA
Panelists (in addition to Speakers):
John Alexander, Deputy Division Director, DPMH, FDA
Chumpitazi, Pediatric Emergency Medicine Specialist, Duke Department of Pediatrics Samina Ali, Professor, Department of Pediatrics, University of Alberta, Canada
Susan Sirota, Founding Partner and CEO, PediaTrust LLC
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| 12:15 - 1:00 p.m. |
Lunch
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Lunch
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Session 2: Potential Unintended Consequences of Deviating from One or More Existing Product Characteristics (Video Recordings)
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| 1:00 p.m. - 1:15 p.m. |
Protecting Access to Pain Relief (PAPR) Coalition
Wade Delk, Board Member and Treasurer, Protecting Access to Pain Relief Coalition
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Presentation
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| 1:15 p.m. - 1:30 p.m. |
Preventing Pediatric Medication Overdose: Strategies, Challenges and Innovations
Maribeth Sivilus, Epidemiologist, CDC Protect
Jennifer Lind, Partnership and Prevention Lead, Medication Safety Program, CDC Protect
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Presentation
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| 1:30 p.m. - 1:45 p.m. |
Lessons from Product Safety Changes to Reduce Pediatric Medication Errors to Acetaminophen (Poison Center Analysis)
Kate Reynolds, Director of Research, Rocky Mountain Poison and Drug Safety
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Presentation
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| 1:45 p.m. - 2:00 p.m. |
Changes to Existing Product Characteristics – the Pharmacist Prospective
Petrea Cober, Professor of Pharmacy Practice, Northeast Ohio Medical University
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Presentation
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| 2:00 p.m. - 2:15 p.m. |
Nonprescription Analgesic/Antipyretic Drug Development in Children 2 to <12 years of Age: A Health Literacy Perspective
Shonna Yin, Associate Professor Pediatrics, New York University
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Presentation
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| 2:15 p.m. - 2:30 p.m. |
Consume Behavior Research: Evaluating When Product Characteristics Might Introduce Problems for Consumers
Russ Bradford, Senior VP Medical Affairs, PEGUS Research
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Presentation
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| 2:30 p.m. - 2:40 p.m. |
Break
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Break
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| 2:40 p.m. - 3:40 p.m. |
Panel Discussion Moderators:
Dorothy Chang, Deputy Director for Safety, DNPD1, FDA
Mona Khurana, Medical Team Leader, DPMH, FDA
Panelists (in addition to Speakers):
Casey Cashman, Director, Pediatric Pain Warrior, U.S. Pain Foundation
Diane Hindman, Attending Physician, University of Arizona College of Medicine
Routt Reigart, Professor Emeritus of Pediatrics, Medical University of South Carolina
Jonathan Zipursky, Clinician-Scientist, Sunnybrook Research Institute, Toronto Canada
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| 3:40 p.m. - 4:00 p.m. |
Closing Remarks and Next Steps
Lynne Yao, Division Director, DPMH, FDA
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Video Recording
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Funding Statement
This workshop is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award to the Center of Excellence in Regulatory Science & Innovation, U01FD005946 totaling $17,205 with 100 percent funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.