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United States · Bill · HR

H.R. 4730 (107th)

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

referredUnited States· United States Congress· EN

Introduced

14 May 2002

Last action

3 June 2002 · Referred

Status

Referred to the Subcommittee on Health.

Sponsors

Rep. Waxman, Henry A. [D-CA-33], Rep. DeLauro, Rosa L. [D-CT-3], Rep. Eshoo, Anna G. [D-CA-18], Rep. Dingell, John D. [D-MI-12], Sen. Brown, Sherrod [D-OH], Rep. Jones, Stephanie Tubbs [D-OH-11], Rep. Mink, Patsy T. [D-HI-2], Rep. Roybal-Allard, Lucille [D-CA-40], Rep. Pallone, Frank [D-NJ-6], Sen. Sanders, Bernard [I-VT], Rep. Kaptur, Marcy [D-OH-9], Rep. Rivers, Lynn N. [D-MI-13], Rep. Frank, Barney [D-MA-4], Rep. Rangel, Charles B. [D-NY-15], Rep. Frost, Martin [D-TX-24], Rep. Millender-McDonald, Juanita [D-CA-37], Rep. Meek, Carrie P. [D-FL-17], Rep. Maloney, Carolyn B. [D-NY-12], Rep. Berman, Howard L. [D-CA-28], Rep. Davis, Danny K. [D-IL-7], Del. Norton, Eleanor Holmes [D-DC-At Large], Sen. Schiff, Adam B. [D-CA], Rep. Slaughter, Louise McIntosh [D-NY-25], Rep. Carson, Julia [D-IN-7], Rep. Hilliard, Earl F. [D-AL-7], Rep. Fattah, Chaka [D-PA-2], Rep. Stark, Fortney Pete [D-CA-13], Rep. Bonior, David E. [D-MI-10], Rep. Snyder, Vic [D-AR-2], Rep. Nadler, Jerrold [D-NY-12], Rep. Woolsey, Lynn C. [D-CA-6], Rep. Cummings, Elijah E. [D-MD-7], Rep. Payne, Donald M. [D-NJ-10], Rep. Miller, George [D-CA-11]

Subjects

Healthcare

Source updated

2 January 2025

Healthcare

Official sourceDownload fileView documentsShare

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

  1. 14 May 2002

    Introduced

    Referred to the House Committee on Energy and Commerce.

    Source: IntroReferral

  2. 14 May 2002

    Introduced

    Introduced in House

    Source: IntroReferral

  3. 14 May 2002

    Introduced

    Introduced in House

    Source: IntroReferral

  4. 3 June 2002

    Referred

    Referred to the Subcommittee on Health.

    Source: Committee

Votes

No vote records are attached yet.

Versions

Documents

3 official files

Introduced in House (text)

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  • Introduced in House (text)

    Introduced in House · EN · 14 May 2002

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  • Introduced in House (PDF)

    Introduced in House · EN · 14 May 2002

    ViewDownloadOpen at official source

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  • Introduced in House

    summary · EN · 14 May 2002

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Sponsors

Related records

Sources

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