United States · Law · S
S. 1789 (107th)
Best Pharmaceuticals for Children Act
Introduced
8 December 2001
Last action
4 January 2002 · President
Status
Became Public Law No: 107-109.
Sponsors
Sen. Dodd, Christopher J. [D-CT], Sen. DeWine, Mike [R-OH]
Subjects
Healthcare
Source updated
7 April 2025
Summary
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.
This text is taken from the official record. PoliticalRepo does not editorialize.
Timeline
8 December 2001
Introduced
Introduced in the Senate. Read the first time. Placed on Senate Legislative Calendar under Read the First Time.
Source: Calendars
8 December 2001
Introduced
Introduced in Senate
Source: IntroReferral
10 December 2001
Calendars
Read the second time. Placed on Senate Legislative Calendar under General Orders. Calendar No. 271.
Source: Calendars
12 December 2001
Floor
Held at the desk.
Source: Floor
12 December 2001
Passed
Passed Senate without amendment by Unanimous Consent. (consideration: CR S13070-13076; text: CR S13071-13076)
Source: Floor
12 December 2001
Floor
Received in the House.
Source: Floor
12 December 2001
Passed
Passed/agreed to in Senate: Passed Senate without amendment by Unanimous Consent.(consideration: CR S13070-13076; text: CR S13071-13076)
Source: Floor
18 December 2001
Floor
DEBATE - The House proceeded with forty minutes of debate on S. 1789.
Source: Floor
18 December 2001
Floor
Considered under suspension of the rules. (consideration: CR H10200-10212)
Source: Floor
18 December 2001
Floor
Mr. Tauzin moved to suspend the rules and pass the bill.
Source: Floor
18 December 2001
Passed
Motion to reconsider laid on the table Agreed to without objection.
Source: Floor
18 December 2001
Passed
On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H10200-10204)
Source: Floor
18 December 2001
Passed
Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote.(text: CR H10200-10204)
Source: Floor
3 January 2002
Floor
Presented to President.
Source: Floor
3 January 2002
President
Presented to President.
Source: President
4 January 2002
Became law
Became Public Law No: 107-109.
Source: President
4 January 2002
Became law
Signed by President.
Source: BecameLaw
4 January 2002
President
Signed by President.
Source: President
Votes
No vote records are attached yet.
Versions
- Enrolled Bill · — · Download file
- Public Law · 4 January 2002 · Download file
- Engrossed in Senate · 12 December 2001 · Download file
- Placed on Calendar Senate · 10 December 2001 · Download file
Documents
10 official files
Enrolled Bill (text)
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Enrolled Bill (text)
Enrolled Bill · EN
Enrolled Bill (PDF)
Enrolled Bill · EN
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Public Law (text)
Public Law · EN · 4 January 2002
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Public Law (PDF)
Public Law · EN · 4 January 2002
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Engrossed in Senate (text)
Engrossed in Senate · EN · 12 December 2001
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Engrossed in Senate (PDF)
Engrossed in Senate · EN · 12 December 2001
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Passed Senate without amendment
summary · EN · 12 December 2001
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Placed on Calendar Senate (text)
Placed on Calendar Senate · EN · 10 December 2001
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Placed on Calendar Senate (PDF)
Placed on Calendar Senate · EN · 10 December 2001
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Introduced in Senate
summary · EN · 7 December 2001
Leesvertaling
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Sponsors
- Sen. Dodd, Christopher J. [D-CT] · D · Sponsor
- Sen. DeWine, Mike [R-OH] · R · Sponsor
Related records
- related to → Best Pharmaceuticals for Children Act
- related to → Best Pharmaceuticals for Children Act
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Related across the Repo ecosystem
Direct relationships are identifier-backed. Topic context means shared TopicMembership — not a citation and not causation.
Direct relationships
- Legal framework · Best Pharmaceuticals for Children Act · S. 1789 (107th) · US
- Identifier matchPROJECTS_FROM
Same us record 107-s-1789 projected from PoliticalRepo US row.
Sources
PoliticalRepo is an index and interpretation layer, not the authoritative legal source.
- Official source: https://www.congress.gov/bill/107th-congress/senate-bill/1789
- Open data entity: https://api.congress.gov/v3/bill/107/s/1789
- us · 107-s-1789 · source updated 7 April 2025