PlainBillCongress, translated.Legislation. Context. Public interest.Congressional Research Service
Version 00 · Introduced in Senate · Dec 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 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.
People & committees
Sen. Dodd, Christopher J. [D-CT] · D–CT
Legislative record
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Became Public Law No: 107-109.
Became Public Law No: 107-109.
Signed by President.
Signed by President.
Presented to President.
Presented to President.
Motion to reconsider laid on the table Agreed to without objection.
On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H10200-10204)
Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote.(text: CR H10200-10204)
DEBATE - The House proceeded with forty minutes of debate on S. 1789.
Considered under suspension of the rules. (consideration: CR H10200-10212)
Mr. Tauzin moved to suspend the rules and pass the bill.
Held at the desk.
Message on Senate action sent to the House.
Received in the House.
Passed Senate without amendment by Unanimous Consent. (consideration: CR S13070-13076; text: CR S13071-13076)
Passed/agreed to in Senate: Passed Senate without amendment by Unanimous Consent.(consideration: CR S13070-13076; text: CR S13071-13076)
Read the second time. Placed on Senate Legislative Calendar under General Orders. Calendar No. 271.
Introduced in the Senate. Read the first time. Placed on Senate Legislative Calendar under Read the First Time.
Introduced in Senate
Primary sources
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Source last updated: Apr 7, 2025. Consult Congress.gov for the current record.
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Analyze S.1789 as objectively as possible. Explain its main provisions, who would be affected, possible benefits and harms, implementation, exceptions, and uncertainties. Present the strongest arguments for and against it, and identify evidence needed to assess its public impact.
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