To amend the Federal Food, Drug, and Cosmetic Act to require labeling containing information applicable to pediatric patients.

Summary

Amends the Federal Food, Drug, and Cosmetic Act to require license applications for new drugs and biological products to assess such drug's or product's safety and effectiveness for relevant pediatric subpopulations, including dosage. Permits extrapolation from adult studies where the course of the disease and the effects of the drug are sufficiently similar in all populations. Permits deferral of such assessments if adult studies are completed earlier and the applicant submits a plan for or a description of planned or ongoing pediatric studies. Permits full waiver of such assessments if: (1) studies are highly impractical or impossible; (2) the evidence strongly suggests that the drug or product would be ineffective or unsafe in all pediatric age groups; (3) there is no meaningful therapeutic advantage or benefit in the pediatric population; or (4) the drug or product is not likely to be used in a substantial number of pediatric patients. Permits partial waivers at the request of an applicant for a specific pediatric subpopulation if any of the full waiver grounds apply to that subpopulation or reasonable attempts for a pediatric formulation for that subpopulation have failed. Requires labels to provide indication in cases in which a waiver has been granted due to evidence a product would be unsafe or ineffective in pediatric populations. Authorizes the Secretary of Health and Human Services to specify a date for submission of pediatric assessments if: (1) the drug or biological product would represent a meaningful therapeutic benefit for pediatric patients for one or more claimed indications and the absence of adequate labeling could pose significant risks to pediatric patients; or (2) it is used for a number of pediatric patients for the labeled indications and the absence of adequate labeling could pose significant risks to pediatric patients. Sets forth criteria for full waiver and partial waivers of such requirement. Requires labels to provide indication in cases in which a waiver has been granted due to evidence a product would be unsafe or ineffective in pediatric populations. Requires the Secretary to issue a written request for related pediatric studies under the Public Health Service Act before requiring an assessment for a drug. States that drugs or products with delayed assessments may be deemed misbranded and subject to seizure and injunctive proceedings, though not penalties.

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3 official files

• Introduced in House (text)

  Introduced in House · EN · 9 October 2002

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• Introduced in House (PDF)

  Introduced in House · EN · 9 October 2002

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• Introduced in House

  summary · EN · 9 October 2002

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