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Best Pharmaceuticals for Children Act

Introduced: May 7, 2001 See on congress.gov
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This bill died when the 107th Congress ended
It never became law before the 107th Congress (2001–2002) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 13 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Oct 23, 2001
Message on Senate action sent to the House.
Oct 23, 2001
Received in the House.
Oct 23, 2001
Held at the desk.
Oct 18, 2001
Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.
Oct 18, 2001
The committee substitute as amended agreed to by Unanimous Consent.
Oct 18, 2001
Measure laid before Senate by unanimous consent. (consideration: CR S10816-10819; text of measure as reported: CR S10816-10818)
Oct 18, 2001
Passed Senate with an amendment by Unanimous Consent.
Oct 4, 2001
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.
Oct 4, 2001
Placed on Senate Legislative Calendar under General Orders. Calendar No. 184.
Aug 1, 2001
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
May 7, 2001
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S4422-4424)
May 7, 2001
Sponsor introductory remarks on measure. (CR S4422)
May 7, 2001
Introduced in Senate
 Amendments to this bill 2

Amendments propose changes to this bill. Members vote on amendments separately before the final bill vote. An agreed amendment becomes part of the bill; a failed amendment does not.

1 agreed to 1 pending / other

AmendmentSponsorPurposeStatusLatest action
SAMDT 1,905 — In the nature of a substitute. Agreed to Oct 18, 2001
SAMDT 1,906 — — Pending —
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 Plain-English summary Congressional Research Service
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.

What's happening now October 23, 2001

Held at the desk.

 Related & companion bills 2
  • HR 2887 Related bill Best Pharmaceuticals for Children Act
  • S 1789 Related bill Best Pharmaceuticals for Children Act
 Bill text 3 versions

Source documents hosted by congress.gov.

 Committees of jurisdiction 1
 Cosponsors 3
All 3 Democratic 2 Republican 1
D
Reed, Jack
Rhode Island · Jul 24, 2001
 D
Murray, Patty
Washington · Jul 23, 2001
 R
Collins, Susan M.
Maine · Jun 8, 2001
Cite this page click to expand
APA
U.S. Congress. (2026). S. 838: Best Pharmaceuticals for Children Act. 107th Congress. Open America. https://openamerica.io/bill/107-S-838/
MLA
"S. 838: Best Pharmaceuticals for Children Act." 107th Congress, 2026, Open America, https://openamerica.io/bill/107-S-838/.
Bluebook (legal)
S. 838, 107th Cong. (2026), https://openamerica.io/bill/107-S-838/.
Markdown link
[S. 838: Best Pharmaceuticals for Children Act](https://openamerica.io/bill/107-S-838/)
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