Skip to main content
HR 2887 107th Congress House Health Administrative procedure Administrative remedies Bioethics Child health Clinical trials Commerce Department of Health and Human Services Drug adulteration Drug approvals Drug industry Economics and Public Finance Executive reorganization Families Foundations Government Operations and Politics Government paperwork Government publicity Governmental investigations Human experimentation in medicine

Best Pharmaceuticals for Children Act

Introduced: September 13, 2001 See on congress.gov
Sign in to write a letter Sign in to watch
 Everywhere this bill has been 18 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Nov 16, 2001
Received in the Senate. Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 228.
Nov 15, 2001
Motion to reconsider laid on the table Agreed to without objection.
Nov 15, 2001
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)
Nov 15, 2001
Passed/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)
Nov 15, 2001
Considered as unfinished business. (consideration: CR H8216)
Nov 13, 2001
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.
Nov 13, 2001
DEBATE - The House proceeded with forty minutes of debate on H.R. 2887.
Nov 13, 2001
Considered under suspension of the rules. (consideration: CR H8094-8107)
Nov 13, 2001
Mr. Tauzin moved to suspend the rules and pass the bill, as amended.
Nov 9, 2001
Placed on the Union Calendar, Calendar No. 167.
Nov 9, 2001
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 107-277.
Oct 11, 2001
Ordered to be Reported (Amended) by the Yeas and Nays: 41 - 6.
Oct 11, 2001
Committee Consideration and Mark-up Session Held.
Oct 5, 2001
Forwarded by Subcommittee to Full Committee (Amended) by the Yeas and Nays: 24 - 5.
Oct 5, 2001
Subcommittee Consideration and Mark-up Session Held.
Sep 27, 2001
Referred to the Subcommittee on Health.
Sep 13, 2001
Referred to the House Committee on Energy and Commerce.
Sep 13, 2001
Introduced in House
 Votes taken on this bill 1
DateChamberWhat was voted onResultYes–No
Nov 15, 2001 House · vote #444 On Motion to Suspend the Rules and Pass, as Amended Passed 338–86 See who voted →
 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 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.

What's happening now November 16, 2001

Received in the Senate. Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 228.

 Committees of jurisdiction 2
 Cosponsors 3
All 3 Democratic 2 Republican 1