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Version 00 · Introduced in Senate · May 7, 2001
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 a list of approved drugs for which: (1) there is no patient 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.
People & committees
Sen. Dodd, Christopher J. [D-CT] · D–CT
Legislative record
A procedural vote is different from passage. Passage in one chamber does not establish enactment. Explore the glossary.
Held at the desk.
Message on Senate action sent to the House.
Received in the House.
Passed Senate with an amendment by Unanimous Consent.
Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.
The committee substitute as amended agreed to by Unanimous Consent.
Measure laid before Senate by unanimous consent. (consideration: CR S10816-10819; text of measure as reported: CR S10816-10818)
Placed on Senate Legislative Calendar under General Orders. Calendar No. 184.
Committee on Health, Education, Labor, and Pensions. Reported by Senator Kennedy with an amendment in the nature of a substitute. With written report No. 107-79.
Committee on Health, Education, Labor, and Pensions. Reported by Senator Kennedy with an amendment in the nature of a substitute. With written report No. 107-79.
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S4422-4424)
Sponsor introductory remarks on measure. (CR S4422)
Introduced in Senate
Primary sources
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Source last updated: Mar 9, 2026. Consult Congress.gov for the current record.
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