(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.