PlainBillCongress, translated.Legislation. Context. Public interest.Received in the Senate. Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 228.
Congressional Research Service
Version 00 · Introduced in House · Sep 13, 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.Amends Title IV of the Public Health Service Act to direct the Secretary to establish the Foundation for Pediatric Research to support research on drugs lacking exclusivity for which pediatric studies are needed.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
Rep. Greenwood, James C. [R-PA-8] · R–PA
Legislative record
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Received in the Senate. Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 228.
Motion to reconsider laid on the table Agreed to without objection.
On motion to suspend the rules and pass the bill, as amended Agreed to by the Yeas and Nays: (2/3 required): 338 - 86 (Roll no. 444). (text: CR 11/13/2001 H8094-8098)
House roll call 444 · Individual votesPassed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by the Yeas and Nays: (2/3 required): 338 - 86 (Roll no. 444).(text: CR 11/13/2001 H8094-8098)
House roll call 444 · Individual votesConsidered as unfinished business. (consideration: CR H8216)
At the conclusion of debate, the Yeas and Nays were demanded and ordered. Pursuant to the provisions of clause 8, rule XX, the Chair announced that further proceedings on the motion would be postponed.
DEBATE - The House proceeded with forty minutes of debate on H.R. 2887.
Considered under suspension of the rules. (consideration: CR H8094-8107)
Mr. Tauzin moved to suspend the rules and pass the bill, as amended.
Placed on the Union Calendar, Calendar No. 167.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 107-277.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 107-277.
Ordered to be Reported (Amended) by the Yeas and Nays: 41 - 6.
Committee Consideration and Mark-up Session Held.
Forwarded by Subcommittee to Full Committee (Amended) by the Yeas and Nays: 24 - 5.
Subcommittee Consideration and Mark-up Session Held.
Referred to the Subcommittee on Health.
Referred to the House Committee on Energy and Commerce.
Introduced in House
Introduced in House
Primary sources
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Source last updated: Apr 7, 2025. Consult Congress.gov for the current record.
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