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U.S. Department of Health and Human Services

Drugs

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Federal Register Notice (69FR7243) (issued 2/13/2004)

[Federal Register: February 13, 2004 (Volume 69, Number 30)]
[Notices]
[Page 7243-7244]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13fe04-101]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


List of Drugs for Which Pediatric Studies Are Needed

ACTION: Notice.

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SUMMARY: The National Institutes of Health (NIH) is providing notice of
a ``List of Drugs for Which Pediatric Studies Are Needed.'' The NIH
developed the list in consultation with the Food and Drug
Administration (FDA) and pediatric experts, as mandated by the Best
Pharmaceuticals for Children Act (BPCA). This list prioritizes certain
drugs most in need of study for use by children to ensure their safety
and efficacy. The NIH will update the list at least annually until the
Act expires on October 1, 2007.

DATES: The list is effective upon publication.

FOR FURTHER INFORMATION CONTACT: Dr. Anne Zajicek, National Institute
of Child Health and Human Development, 6100 Executive Boulevard, Suite
4B-11, Bethesda, MD 20892-7510, e-mail
BestPharmaceuticals@mail.nih.gov,

[[Page 7244]]

telephone 301-435-6865 (not a toll-free number).

SUPPLEMENTARY INFORMATION: The NIH is providing notice of a ``List of
Drugs for Which Pediatric Studies Are Needed,'' as authorized under
section 3, Public Law 107-109 (42 U.S.C. 409I). On January 4, 2002,
President Bush signed into law the Best Pharmaceuticals for Children
Act (BPCA). The BPCA mandates that not later than one year after the
date of enactment, the NIH in consultation with the FDA and experts in
pediatric research shall develop, prioritize, and publish an annual
list of certain 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)); (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; (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
in 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 list, the NIH consulted with the FDA, the
American Academy of Pediatrics, and other experts in pediatric research
and practice. A preliminary list of drugs was drafted and categorized
as a function of indication and use. The drugs were than 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.
The following are the drugs newly added to the list for which
pediatric studies are most urgently needed and their indications for
use:

Ampicillin--infections;
Ketamine--sedation;
Vincristine--malignancies;
Dactinomycin--malignancies;
Metolazone--diuresis.

Drugs that were previously listed as urgently needing studies,
their indications for use, and their current status, are described in
the table.

------------------------------------------------------------------------
Indications for pediatric
Drug needing pediatric study use Status
------------------------------------------------------------------------
Lorazepam....................... Sedation in the Intensive 1
Care Unit.
Treatment of status 1
epilepticus.
Nitroprusside................... Reduction of blood 1
pressure.
Baclofen........................ Oral treatment of 1
spasticity of cerebral
palsy.
Azithromycin.................... Prevention of 1
bronchopulmonary
dysplasia in neonates
colonized with U.
urealyticum.
Treatment of Chlamydia 2
pneumonia, prevention of
Chlamydia conjunctivitis
and pneumonia.
Lithium......................... Treatment of mania in 1
bipolar disorder.
Ampicillin/sulbactam............ Pediatric infections...... 2
Diazoxide....................... Hypoglycemia.............. 2
Isoflurane...................... Maintenance of general 2
anesthesia.
Meropenem....................... Pediatric infections...... 2
Metoclopramide.................. Gastroesophageal reflux... 2
Piperacillin/tazobactam......... Pediatric infections...... 2
Promethazine.................... Nausea/vomiting........... 2
Rifampin........................ Staphylococcus 2
endocarditis.
CNS shunt infections...... 2
Lindane......................... 2nd line treatment of 2
scabies.
Heparin......................... Anticoagulant............. \1\
Bumetanide...................... Diuresis.................. 3
Furosemide...................... Diuresis.................. 3
Dobutamine...................... Increase cardiac output... 3
Dopamine........................ Increase cardiac output... 3
Spironolactone.................. Diuresis.................. 3
------------------------------------------------------------------------
\1\ Drug labeled for use in children.

Status: 1 = Contract being developed; 2 = Written Request
being developed; 3 = Drug undergoing extensive review by NIH and FDA.


Dated: February 6, 2004.
Elias A. Zerhouni,
Director, National Institutes of Health.
[FR Doc. 04-3179 Filed 2-12-04; 8:45 am]
BILLING CODE 4140-01-P