H.R. 3452 (107th): Best Pharmaceuticals for Children Act

Dec 11, 2001 (107th Congress, 2001–2002)
Died (Referred to Committee) in a previous session of Congress
See Instead:

S. 1789 (same title)
Signed by the President — Jan 04, 2002

This bill was introduced on December 11, 2001, in a previous session of Congress, but was not enacted.

Dec 11, 2001
James “Jim” Greenwood
Representative for Pennsylvania's 8th congressional district
Read Text »
Last Updated
Dec 11, 2001
46 pages
Related Bills
S. 1789 (identical)

Signed by the President
Jan 04, 2002

Full Title

To amend the Federal Food, Drug, and Cosmetic Act to improve the safety and efficacy of pharmaceuticals for children.


No summaries available.

1 cosponsors (1D) (show)

House Energy and Commerce


The committee chair determines whether a bill will move past the committee stage.

Primary Source

THOMAS.gov (The Library of Congress)

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H.R. stands for House of Representatives bill.

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The bill’s title was written by its sponsor.

GovTrack’s Bill Summary

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Library of Congress Summary

The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress.

Best Pharmaceuticals for Children Act - Amends the Public Health Service Act to direct the Secretary of Health and Human Services, through the National Institutes of Health, to develop an annual list of approved drugs for which:
(1) there is an approved or pending new drug application or no patent or market exclusivity protection; and
(2) additional pediatric safety and effectiveness studies are needed.
Directs the Secretary to award contracts to entities with appropriate experience for pediatric clinical trials of such drugs.Establishes a Food and Drug Administration (FDA) contract process for related labeling changes.Amends the Federal Food, Drug, and Cosmetic Act to:
(1) eliminate the user fee waiver for pediatric supplements to a human drug application;
(2) provide priority status for pediatric supplements;
(3) include neonates within the definition of pediatric studies;
(4) provide for dissemination of pediatric supplement information; and
(5) set forth requirements for the additional six-month exclusivity period for new or already-marketed pediatric drugs.Directs the Secretary to establish an Office of Pediatric Therapeutics within the Office of the Commissioner of Food and Drugs, which shall coordinate all FDA pediatric activities.Includes within the purposes and activities of the Foundation for the National Institutes of Health the collection of funds for pediatric pharmacological research.Directs the Secretary to contract with the Institute of Medicine to review Federal regulations, reports, and support for research involving children, with particular attention to issues of compensation, informed consent, and risk/ benefits assessments in terms of research versus therapeutic treatment.

House Republican Conference Summary

The summary below was written by the House Republican Conference, which is the caucus of Republicans in the House of Representatives.

No summary available.

House Democratic Caucus Summary

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