Regulatory Focus™ > News Articles > 2019 > 3 > FDA Finalizes Guidance on Pediatric Information in Drug Labels

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Posted 27 March 2019 | By Michael Mezher 

FDA Finalizes Guidance on Pediatric Information in Drug Labels

2784 The US Food and Drug Administration (FDA) on Wednesday finalized guidance on the content and placement of pediatric information within the labeling of drugs and biologics.
“The goal of this guidance is to provide recommendations to help ensure that information on the use of prescription drugs in pediatric populations (whether positive, negative, or inconclusive) is consistently placed in the proper sections and subsections within labeling so that the information is clear and accessible to health care providers,” FDA writes.
The final guidance comes just over a year after the agency released the draft version for public comment. According to FDA, the 15-page guidance has been revised for clarity and to be more consistent with other recently published labeling guidances.
Notably, the background section of the final guidance has been trimmed down and no longer includes subsections on extrapolation and categories of pediatric data for decision making, which discussed whether data from studies (or lack thereof) would be sufficient or insufficient to warrant a pediatric indication or pediatric use.

As with the draft guidance, the remainder of the final version focuses on what pediatric information sponsors should include, which the agency now breaks into four scenarios:
  • “Scenario 1: The evidence supports the safety and effectiveness of a drug for an indication in pediatric patients (either all pediatric patients or in a specific pediatric age group(s));
  • Scenario 2: The evidence does not support the safety and effectiveness of a drug for an indication in pediatric patients … because results of studies conducted in that population were negative (i.e., data from studies strongly suggest that the drug would be ineffective or unsafe) or inconclusive;
  • Scenario 3: There is no evidence available to support safety and effectiveness of an indication in pediatric patients … because studies have not been conducted or are ongoing in that population and/or studies in pediatric patients … have been waived under [the Pediatric Research Equity Act] PREA;
  • Scenario 4: Based on available evidence, the drug is contraindicated for use in all pediatric patients, a specific pediatric age group(s), or a specific subgroup of pediatric patients.”
For each of these scenarios, the guidance lays out which sections of labeling should include pediatric information, and what specific information should be included.
The final guidance also includes an expanded section on juvenile animal data, which previously only stated that such data should be included in the Pediatric Use subsection of the labeling. However, in the final guidance FDA has changed its recommendation to emphasize that juvenile animal data should be included only “when the data suggest an adverse signal(s) that has not been previously assessed in a pediatric clinical study.”
FDA also notes that it plans to issue separate guidance on pediatric use information for biosimilars licensed under section 351(k) of the Public Health Service Act.
FDA, Federal Register Notice


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