Summary: S.838 — 107th Congress (2001-2002)All Information (Except Text)

Bill summaries are authored by CRS.

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Passed Senate amended (10/18/2001)

Best Pharmaceuticals for Children Act - Amends the Federal Food, Drug, and Cosmetic Act (Act) to eliminate the requirement that the Secretary of Health and Human Services develop a priority list of drugs for which additional pediatric information may be beneficial. Provides that a drug may qualify for a written request for pediatric studies if the Secretary determines that information relating to the use of an approved drug may produce pediatric health benefits.

(Sec. 3) Amends the Public Health Service Act to direct the Secretary, through the National Institutes of Health, to develop a list of approved drugs for which: (1) there is no patent or market exclusivity protection, and additional pediatric safety and effectiveness studies are needed; or (2) there is an approved or submitted application. Directs the Secretary to award contracts to entities with appropriate pediatric clinical trials experience.

Establishes a Food and Drug Administration (FDA) contract process for the studies and labeling changes of drugs lacking patent and other market exclusivity protections, including authority to declare a drug misbranded for manufacturer failure to make a requested labeling change. Authorizes appropriations through FY 2007.

(Sec. 4) Amends the Act to set forth provisions concerning written requests for studies to holders of approved applications for drugs that have market exclusivity. Requires a holder agreeing to a study to indicate when the study will commence. Provides that if the holder does not agree to a written request within a specified period, and if the Secretary determines that there is a continuing need for information relating to the use of the drug in the pediatric population, the Secretary shall refer the drug to the Foundation for the National Institutes of Health for the conduct of the pediatric studies described in the written request.

(Sec. 5) Amends the 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; (5) prohibit a drug from receiving the six-month pediatric exclusivity unless on or before October 1, 2007, the Secretary makes a written request for pediatric studies and an approvable application is submitted; (6) set forth rules for situations of overlapping pediatric exclusivity and certain abbreviated new drug approval exclusivity; and (7) provide for prompt approval of certain abbreviated drug applications when specified pediatric information is added to the labeling.

(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. 12) Directs the Secretary to contract with the Institute of Medicine for a study of Federal regulations respecting research involving children, including federally-supported reports and evidence-based research.

(Sec. 13) Amends the Public Health Service Act to permit the Foundation for the National Institutes of Health to collect funds and award grants for pediatric research and studies on drugs.

(Sec. 14) Directs the Secretary to convene and consult an advisory committee on pediatrics.

(Sec. 15) Directs the Secretary to report to Congress concerning the effectiveness and impact of this Act concerning pediatric medicines.