S. 2394 (107th)

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

openUnited States· United States Congress· EN

Introduced

29 April 2002

Last action

8 October 2002 · Committee

Status

By Senator Kennedy from Committee on Health, Education, Labor, and Pensions filed written report. Report No. 107-300. Additional views filed.

Summary

Amends the Federal Food, Drug, and Cosmetic Act to require license applications for new drug and biological product 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. Authorizes the Secretary of Health and Human Services to specify a date for submission of pediatric assessments if a drug's or product's use or need in the pediatric populations so dictates. States that drugs or products with delayed assessments will be deemed misbranded and subject to seizure and injunctive proceedings, though not penalties. Permits full waiver of such assessments if: (1) studies are highly impracticable or impossible and the evidence suggests that the drug or product would be ineffective or unsafe in all pediatric age groups; or (2) there is no meaningful therapeutic advantage or benefit in the pediatric population and little risk if used as labeled. 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 of these drugs or products to reflect such waivers.

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

29 April 2002
Introduced
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Source: IntroReferral
29 April 2002
Introduced
Introduced in Senate
Source: IntroReferral
1 August 2002
Calendars
Placed on Senate Legislative Calendar under General Orders. Calendar No. 547.
Source: Calendars
1 August 2002
Reported
Committee on Health, Education, Labor, and Pensions. Ordered to be reported without amendment favorably.
Source: Committee
1 August 2002
Reported
Committee on Health, Education, Labor, and Pensions. Reported by Senator Kennedy with an amendment. Without written report.
Source: Committee
8 October 2002
Floor
By Senator Kennedy from Committee on Health, Education, Labor, and Pensions filed written report. Report No. 107-300. Additional views filed.
Source: Floor
8 October 2002
Committee
By Senator Kennedy from Committee on Health, Education, Labor, and Pensions filed written report. Report No. 107-300. Additional views filed.
Source: Committee

Votes

No vote records are attached yet.

Versions

Reported to Senate · 1 August 2002 · Download file
Introduced in Senate · 29 April 2002 · Download file

Documents

6 official files

Reported to Senate (text)

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Reported to Senate (text)
Reported to Senate · EN · 1 August 2002
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Reported to Senate (PDF)
Reported to Senate · EN · 1 August 2002
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Reported to Senate with amendment(s)
summary · EN · 1 August 2002
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Introduced in Senate (text)
Introduced in Senate · EN · 29 April 2002
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Introduced in Senate (PDF)
Introduced in Senate · EN · 29 April 2002
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Introduced in Senate
summary · EN · 29 April 2002
Open at official source
Leesvertaling
Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.
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Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

Related records

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

Sources

PoliticalRepo is an index and interpretation layer, not the authoritative legal source.

Official source: https://www.congress.gov/bill/107th-congress/senate-bill/2394
Open data entity: https://api.congress.gov/v3/bill/107/s/2394
us · 107-s-2394 · source updated 21 April 2025