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Lindane
listed among drugs for which
pediatric studies are urgently needed
National Institute of Health reviewing part of the
Best Pharmaceuticals for Children Act
The NIH is
providing notice of a "List of Additional Drugs for Which Pediatric
Studies Are Needed." On January 4, 2002, President Bush signed into law
the Best Pharmaceuticals for Children Act (BPCA). The BPCA mandates that
the NIH in consultation with the FDA and experts in pediatric research
shall develop, prioritize, and publish on at least an annual basis a list
of approved drugs for which pediatric studies are needed. For inclusion on
the list, an approved drug must meet the following criteria: (1) There is
an approved application under section 505(j) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(j)); or (2) there is a submitted
application that could be approved under the criteria of section 505(j) of
the Federal Food, Drug, and Cosmetic Act; or (3) there is no patent
protection or market exclusivity protection under the Federal Food, Drug,
and Cosmetic Act; or (4) there is a referral for inclusion on the list
under section 505A(d)(4)(c); and additional studies are needed to assess
the safety and effectiveness of the use of the drug in the pediatric
population. The BPCA further stipulates that ill developing and
prioritizing the list, the NIH shall consider, for each drug on the list:
(1) The availability of information concerning the safe and effective use
of the drug in the pediatric population; (2) whether additional
information is needed; (3) whether new pediatric studies concerning the
drug may produce health benefits in the pediatric population; and (4)
whether reformulation of the drug is necessary.
In developing this addition to the initial list published on January 21,
2003, the NIH consulted with the FDA, the American Academy of Pediatrics,
the United States Pharmacopoeia and other experts in pediatric research. A
preliminary list of certain off-patent drugs was drafted and categorized
as a function of indication and use. The drugs were then prioritized based
on frequency of use in the pediatric population, severity of the condition
being treated, and potential for providing a health benefit in the
pediatric population.
Following are the additional drugs for which pediatric studies are most
urgently needed:
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Ampicillin/sulbactam
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Diazoxide
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Isoflurane
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Lindane
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Meropenem
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Metoclopramide
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Piperacillin/tazobactam
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Promethazine
Elias A.
Zerhouni,
Director, National Institutes of Health
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