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107th Congress

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Best Pharmaceuticals for Children Act

P.L. 107-109 (S. 1789)

Impact of Public Law

Public Law (P.L.) 107-109, the Best Pharmaceuticals for Children Act, reauthorizes the pediatric studies provision of the Food and Drug Administration Modernization and Accountability Act of 1997 to improve the safety and efficacy of pharmaceuticals for children. It continues to encourage pharmaceutical companies to conduct pediatric studies of on-patent drugs that are used in pediatric populations, but are not labeled for such use, by extending their market exclusivity. In addition, P.L. 107-109 authorizes studies for off-patent drugs by the Federal Government or other entities with the expertise to conduct pediatric clinical trials.

P.L. 107-109 contains the following provisions that are relevant to the National Institutes of Health (NIH):

  • Pediatric Drug List and Research Fund: Section 3 requires the Director of NIH, in consultation with the Commissioner of the Food and Drug Administration (FDA) and experts in pediatric research, to develop, prioritize, and publish a list of drugs for which pediatric studies are needed and for which the Secretary of Health and Human Services (HHS) must award contracts for the conduct of pediatric clinical trials. This section also requires that the Commissioner of FDA consult with the Director of NIH to issue written requests for studies to holders of approved applications for drugs lacking exclusivity. To carry out these studies when drug companies refuse to do so, the law authorizes $200 million in fiscal year (FY) 2000 and such sums as are necessary for each of the five succeeding fiscal years.
  • Foundation for NIH: Section 4 allows the Secretary of HHS to refer a drug to the Foundation for NIH (FNIH) when the Secretary determines there is a need for information relating to the use of the drug and the drug manufacturer does not agree to conduct a study. In addition, it further requires the FNIH to award a grant to conduct the requested study unless the FNIH certifies to the Secretary that FNIH does not have the funds available to conduct the requested studies. If the FNIH so certifies, the Secretary must refer the drug for inclusion on the established list.

  • Section 13 amends the FNIH legal authority (Public Health Service Act, 42 U.S.C. 290b) to allow the FNIH to collect funds for pediatric pharmacologic research. It also requires that pediatric medicine research experts be members of the Foundation's Board.
  • Institute of Medicine (IOM) Study: Section 12 requires the Secretary of HHS to contract with the IOM to conduct a study on best practices that relates to research involving children.
  • National Cancer Institute (NCI) Directives: Section 15 requires that at least two pediatric oncology specialists from NCI participate on the Pediatric Subcommittee of the Oncologic Drugs Advisory Committee to review and evaluate data concerning the safety and effectiveness of drugs for use in the treatment of pediatric cancers. This section also directs NCI to expand, intensify, and coordinate research activities that evaluate therapies effective for treating pediatric cancer and to coordinate those activities with other NIH Institutes.

Legislative History

On December 8, 2001, Senator Christopher Dodd (D-CT) introduced S. 1789, the Best Pharmaceuticals for Children Act. It was read for the first time and placed on the Senate Legislative Calendar.

On December 10, 2001, the bill was read for the second time and placed on the Senate Legislative Calendar under General Orders.

The Senate passed S. 1789 without amendment and by unanimous consent on December 12, 2001.

On December 12, 2001, the bill was received in the House. Representative W.J. "Billy" Tauzin (R-LA) moved to suspend the rules and pass the bill. That motion was agreed to by voice vote. On that same day, a motion to reconsider was laid on the table and agreed to without objection.

On January 3, 2002, the bill was presented to the President. The President signed the bill on January 4, 2002, when it became P.L. 107-109.



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