Pediatric Research Improvement Act

A bill to improve pediatric research.

3/27/2007--Introduced.
Pediatric Research Improvement Act - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to direct an applicant seeking to waive submission requirements related to pediatric assessments of the safety and effectiveness of a drug or biological product to submit to the Secretary of Health and Human Services documentation detailing why a pediatric formulation cannot be developed. Requires an applicant seeking to defer submission of some or all of such assessments to submit to the Secretary a timeline for the completion of pediatric studies.
Requires the Secretary to create an internal committee to review pediatric assessment requests issued, pediatric assessments conducted, and deferral and waiver requests. Considers a supplement to a new drug or biological license application proposing a labeling change as a result of any pediatric assessments to be a priority supplement. Sets forth dispute resolution procedures for labeling changes for pediatric drugs.
Requires the Commissioner of the Food and Drug Administration (FDA) to make available to the public the medical, statistical, and clinical pharmacology reviews of pediatric assessments.
Requires the Secretary to:
(1) require sponsors of the assessments that result in labeling changes to distribute such information to physicians and other health care providers;
(2) ensure that all adverse event reports that have been received for such a drug are referred to the Office of Pediatric Therapeutics for one year after a labeling change; and
(3) contract with the Institute of Medicine to study and report to Congress regarding the pediatric studies conducted pursuant to FFDCA since 1997.
Requires the Comptroller General to report to Congress on the effectiveness of FFDCA provisions relating to pediatric studies in ensuring that medicines used by children are tested and properly labeled.


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Sponsor

• Sen. Hillary Clinton [D, NY]
• and 1 Co-Sponsors
  • Sen. Christopher Dodd [D, CT]
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Committees

• Senate Health, Education, Labor, and Pensions

Amendments

This bill has no amendments.

Amendments to S.993

Number	Status	Purpose

Bill Status

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Introduced		Voted on by Senate		Voted on by House		Considered By President		Bill Becomes Law
March 27, 2007

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All Bill Actions

• Mar 27, 2007: Introductory remarks on measure. (CR S3842)
• Introduced on Mar 27, 2007.
• Mar 27, 2007: Sponsor introductory remarks on measure. (CR S3842)
• Mar 27, 2007: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

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Related Issue Areas:

• Medicine
• Children
• Congress
• Congressional investigations
• 12 more
• Congressional reporting requirements
• Consumers
• Drug approvals
• Government information
• Government paperwork
• Governmental investigations
• Labeling
• Medical care
• Pediatrics
• Pharmaceutical research
• Science policy
• Child health

Data from the Congressional Research Service

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December 11, 2008 Deutschland Archiv: Zeitschrift für das vereinigte Deutschland - H ...

Zur Souveränität der DDR am Beispiel des Diensthabenden Systems der Luftverteidigung S. 993-1002. Hans-Joachim Teichler: Die Stimmungs- und Wirtschaftslage 1988/89 in der DDR. Reflexionen in den Leiterinformationen für ...

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December 09, 2008 Deutschland Archiv: Zeitschrift für das vereinigte Deutschland - H ...

Zur Souveränität der DDR am Beispiel des Diensthabenden Systems der Luftverteidigung S. 993-1002. Hans-Joachim Teichler: Die Stimmungs- und Wirtschaftslage 1988/89 in der DDR. Reflexionen in den Leiterinformationen für das ...

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August 19, 2008 FRANCIS A. BOYLE

Testimony in Support of S. 993, 101st Cong., 1st Sess., The Biological Weapons Anti-Terrorism Act of 1989 (July 26, 1989), in Hearing Before the Senate Committee on the Judiciary, S. HRG. 101-416, Serial No. J-101-32, at 100 (1989). ...

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