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  • 1.  Pediatric Age Subgroups

    This message was posted by a user wishing to remain anonymous
    Posted 07-Jul-2020 08:49
    This message was posted by a user wishing to remain anonymous

    Dear Forum,

    Why does the FDA not include 17 year old in the pediatric age groups?

    Thank you for your assistance - it is greatly appreciated.


  • 2.  RE: Pediatric Age Subgroups

    Posted 08-Jul-2020 13:26
    I am not aware of any written explanation of why FDA defines pediatric age less than 17 years of age. I speculate that it is because the HHS, FDA's parent organization, and the ICH E11 guidance definitions are based on establishment by a local jurisdiction of age of consent, which can include 16-year-olds. In most US states the age of consent is 16 years. Note that a relatively recent guidance on study of oncology products in pediatrics includes 17-year-olds.

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    Glen Park PharmD
    Executive Director, Regulatory Affairs and Quality Assurance
    Jersey City NJ
    United States
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    Original Message


  • 3.  RE: Pediatric Age Subgroups

    Posted 08-Jul-2020 13:49
    FDA does not explicitly exclude 17 year olds.
    Please see attached harmonized ICH/FDA pediatric guidance (E11) and an excerpt is provided below: https://www.fda.gov/media/71355/download

    "5. Adolescents (12 to 16-18 years (dependent on region)) (2.5.5)
    This is a period of sexual maturation; medicinal products may interfere with the actions of
    sex hormones and impede development. In certain studies, pregnancy testing and review
    of sexual activity and contraceptive use may be appropriate.
    This is also a period of rapid growth and continued neurocognitive development.
    Medicinal products and illnesses that delay or accelerate the onset of puberty can have a
    profound effect on the pubertal growth spurt and, by changing the pattern of growth, may
    affect final height. Evolving cognitive and emotional changes could potentially influence the
    outcome of clinical studies.
    Many diseases are also influenced by the hormonal changes around puberty (e.g.,
    increases in insulin resistance in diabetes mellitus, recurrence of seizures around
    menarche, changes in the frequency and severity of migraine attacks and asthma
    exacerbations). Hormonal changes may thus influence the results of clinical studies.
    Within this age group, adolescents are assuming responsibility for their own health and
    medication. Noncompliance is a special problem, particularly when medicinal products
    (for example, steroids) affect appearance. In clinical studies compliance checks are
    important. Recreational use of unprescribed drugs, alcohol, and tobacco should be
    specifically considered.
    The upper age limit varies among regions. It may be possible to include older adolescents
    in adult studies, although issues of compliance may present problems. Given some of the
    unique challenges of adolescence, it may be appropriate to consider studying adolescent
    patients (whether they are to be included in adult or separate protocols) in centers
    knowledgeable and skilled in the care of this special population.

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    GRSAOnline
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    Original Message


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