It was just last week, on October 7, 2024, when we published a blog (here) titled FDA Planned OTC Monograph Actions.  That post outlined the OTC monograph issues that the Agency was planning to address over the next three years.  Well, obviously, the FDA must have had its eyes set on beginning efforts on the issue of pediatric indications for over-the-counter antipyretic and analgesic products as the Agency today announced a public meeting (here) to discuss this issue and kick off its project of evaluating OTC products.

The November 15, 2024 meeting will be held at the FDA’s White Oak Campus and will be available for in-person or virtual attendance.

The Agency indicates that “[t]he 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.”

The topics that the Agency wants to explore 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 already established labeled uses (for temporary relief of minor aches and pains due to the common cold, sore throat, flu, headache, and toothache, as well as fever reduction); and
  • 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.

For those of you that are in the OTC space, treat pediatric patients, or have kids of your own, the discussions at this meeting will be of significant importance to you.  While no final decisions will be made at the meeting, the discussions will certainly inform the FDA’s final decision-making process.