Public Laws | Other Legislation
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
- Foundation for NIH:
Section 4 allows the Secretary of HHS to refer a drug to
the Foundation for NIH
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
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
- 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
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.