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United States · Law · S

S. 650 (108th)

Pediatric Research Equity Act of 2003

enactedUnited States· United States Congress· EN

Introduced

18 March 2003

Last action

3 December 2003 · President

Status

Became Public Law No: 108-155.

Sponsors

Sen. DeWine, Mike [R-OH], Sen. Clinton, Hillary Rodham [D-NY], Sen. Gregg, Judd [R-NH], Sen. Dodd, Christopher J. [D-CT], Sen. Kennedy, Edward M. [D-MA], Sen. Murray, Patty [D-WA], Sen. Frist, William H. [R-TN]

Subjects

Healthcare

Source updated

21 April 2025

Healthcare

Official sourceDownload fileView documentsShare

Summary

Pediatric Research Equity Act of 2003 - 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 deferral of such assessments under specified circumstances. Permits full waiver of such assessments under certain conditions, including if: (1) studies are highly impractical or impossible; or (2) there is no meaningful therapeutic advantage or benefit in the pediatric population. 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 or under this Act before requiring an assessment for a drug. Directs the Secretary, after determining that there is no agreement to such a written request, to certify whether the Secretary has sufficient funds to conduct the study under the Public Health Service Act, taking into account prioritization of drugs for which pediatric studies are needed. States that if a person fails to submit an assessment under this Act, or a request for approval of a pediatric formulation, the relevant drug or biological product may be considered misbranded and subject to enforcement action.

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

Timeline

  1. 18 March 2003

    Introduced

    Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S3898-3900)

    Source: IntroReferral

  2. 18 March 2003

    Introduced

    Sponsor introductory remarks on measure. (CR S3897-3898)

    Source: IntroReferral

  3. 18 March 2003

    Introduced

    Introduced in Senate

    Source: IntroReferral

  4. 19 March 2003

    Reported

    Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment favorably.

    Source: Committee

  5. 27 June 2003

    Calendars

    Placed on Senate Legislative Calendar under General Orders. Calendar No. 183.

    Source: Calendars

  6. 27 June 2003

    Reported

    Committee on Health, Education, Labor, and Pensions. Reported by Senator Gregg with an amendment. With written report No. 108-84. Additional views filed.

    Source: Committee

  7. 27 June 2003

    Reported

    Committee on Health, Education, Labor, and Pensions. Reported by Senator Gregg with an amendment. With written report No. 108-84. Additional views filed.

    Source: Committee

  8. 23 July 2003

    Reported

    Measure laid before Senate by unanimous consent. (consideration: CR S9811-9819; text of measure as reported in Senate: CR S9811-9813)

    Source: Floor

  9. 23 July 2003

    Passed

    Passed/agreed to in Senate: Passed Senate with amendments by Unanimous Consent.(text as passed Senate: CR S9816-9818)

    Source: Floor

  10. 24 July 2003

    Introduced

    Referred to the House Committee on Energy and Commerce.

    Source: IntroReferral

  11. 24 July 2003

    Floor

    Received in the House.

    Source: Floor

  12. 24 July 2003

    Floor

    Message on Senate action sent to the House.

    Source: Floor

  13. 8 August 2003

    Referred

    Referred to the Subcommittee on Health.

    Source: Committee

  14. 19 November 2003

    Floor

    DEBATE - The House proceeded with forty minutes of debate on S. 650.

    Source: Floor

  15. 19 November 2003

    Floor

    Considered under suspension of the rules. (consideration: CR H11567-11572)

    Source: Floor

  16. 19 November 2003

    Passed

    Motion to reconsider laid on the table Agreed to without objection.

    Source: Floor

  17. 19 November 2003

    Passed

    On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H11567-11569)

    Source: Floor

  18. 19 November 2003

    Passed

    Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote.(text: CR H11567-11569)

    Source: Floor

  19. 19 November 2003

    Floor

    Mr. Bilirakis moved to suspend the rules and pass the bill.

    Source: Floor

  20. 21 November 2003

    Floor

    Presented to President.

    Source: Floor

  21. 21 November 2003

    President

    Presented to President.

    Source: President

  22. 3 December 2003

    Became law

    Became Public Law No: 108-155.

    Source: President

  23. 3 December 2003

    Became law

    Signed by President.

    Source: BecameLaw

  24. 3 December 2003

    President

    Signed by President.

    Source: President

Votes

No vote records are attached yet.

Versions

Documents

15 official files

Enrolled Bill (text)

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  • Enrolled Bill (text)

    Enrolled Bill · EN

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  • Enrolled Bill (PDF)

    Enrolled Bill · EN

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  • Public Law (text)

    Public Law · EN · 3 December 2003

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  • Public Law (PDF)

    Public Law · EN · 3 December 2003

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  • Public Law

    summary · EN · 3 December 2003

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  • Referred in House (text)

    Referred in House · EN · 24 July 2003

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  • Referred in House (PDF)

    Referred in House · EN · 24 July 2003

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  • Engrossed in Senate (text)

    Engrossed in Senate · EN · 23 July 2003

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  • Engrossed in Senate (PDF)

    Engrossed in Senate · EN · 23 July 2003

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  • Passed Senate amended

    summary · EN · 23 July 2003

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  • Reported to Senate (text)

    Reported to Senate · EN · 27 June 2003

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  • Reported to Senate (PDF)

    Reported to Senate · EN · 27 June 2003

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  • Introduced in Senate (text)

    Introduced in Senate · EN · 18 March 2003

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  • Introduced in Senate (PDF)

    Introduced in Senate · EN · 18 March 2003

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  • Introduced in Senate

    summary · EN · 18 March 2003

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