S 1789 · 107th Congress 2001–2003, ended

Best Pharmaceuticals for Children Act

Introduced Dec 8, 2001 Originated Senate Sponsor Christopher J. Dodd D-CT

Fact sheet

Latest action · Jan 4, 2002 Became Public Law No: 107-109.

Progress

Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.

IntroducedDec 8, 2001
Passed SenateDec 12, 2001
Passed HouseDec 18, 2001
To the PresidentJan 3, 2002
Became lawJan 4, 2002

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 (NIH), to develop an annual list of approved drugs for which: (1) there is a referral, 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. Requires the results of such trials to be reported to the Commissioner of Food and Drugs who shall then determine and request any necessary labeling changes. Authorizes the Commissioner to deem a drug misbranded if the holder of an approved application refuses to make the requested change. Requires the Secretary to send a nonbinding letter of recommendation to an approved application holder if such studies indicate a reformulation is necessary. Sets forth reporting, label change, and dispute resolution requirements.

(Sec. 4) Amends the Federal Food, Drug, and Cosmetic Act to set forth procedures for written requests for pediatric studies to holders of approved applications for drugs that have market exclusivity. Requires the Secretary to refer such drugs to the Foundation for the National Institutes of Health for pediatric studies if the need for more information continues and the holder refuses. Directs the Secretary to refer such drug onward to the Public Health Service list if the Foundation has insufficient funds to conduct the study.

(Sec. 6) 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.

(Sec. 7) 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 age groups for 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.

(Sec. 11) Requires only an abbreviated application for new drug approval for generic drugs with added pediatric information.

(Sec. 12) 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.

(Sec. 13) Includes within the purposes and activities of the Foundation for the National Institutes of Health the collection of funds for pediatric pharmacologic research.

(Sec. 14) Directs the Secretary to convene and consult an advisory committee on pediatric pharmacology to advise and make recommendations to the Secretary on matters relating to pediatric pharmacology.

(Sec. 15) Sets forth the duties of the Pediatric Subcommittee of the Oncologic Drugs Advisory Committee in carrying out its mission of reviewing and evaluating data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of pediatric cancers.

Requires the Director of the National Cancer Institute to expand, intensify, and coordinate the activities of the Institute with respect to research and the development of preclinical models to evaluate which therapies are likely to be effective for treating pediatric cancer.

(Sec. 16) Directs the Comptroller General of the United States, in consultation with the Secretary, to submit to Congress a report concerning the effectiveness and economic impact of pediatric drug studies, the nature and type of studies in children for each drug granted exclusivity, recommendations, and other matters.

(Sec. 17) Establishes an adverse reaction toll-free number which must appear on the labels of drugs approved under new drug application procedures. Requires that adverse effects from drugs with pediatric market exclusivity be reported to and reviewed by the Office of Pediatric Therapeutics.

(Sec. 18) Requires pediatric studies to take into account adequate representation of children of ethnic and racial minorities and directs the Comptroller General to study and report on the representation of ethnic and racial minority children in such studies.

Cosponsors 1

Members who signed on, in the order they did. All signed on Dec 8, 2001.

Seat	Cosponsor		Signed on
R-OH	Mike DeWine	Original	Dec 8, 2001

Actions 17

Everything that happened, newest first.

Jan 4, 2002Became Public Law No: 107-109.
Jan 4, 2002Signed by President.
Jan 3, 2002Presented to President.
Dec 18, 2001Considered under suspension of the rules. (consideration: CR H10200-10212)
Dec 18, 2001DEBATE - The House proceeded with forty minutes of debate on S. 1789.

Show all 17 actions

Related bills 3

Companion bills and other measures the record links to this one.

Bill	Title	Relationship	Latest action
S 838	Best Pharmaceuticals for Children Act	Related bill	Oct 23, 2001
HR 2887	Best Pharmaceuticals for Children Act	Related bill	Nov 16, 2001
HR 3452	Best Pharmaceuticals for Children Act	Identical bill	Dec 28, 2001

Subjects

Assigned by the Library of Congress. Policy area: Health.

Support LegiList

This page is free, carries no paywall, and is built and maintained by one person. If the record here is useful to you, a few dollars keeps it going.

$1 $5 $10

Processed by Stripe in a separate window. LegiList never sees card details.

Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov.