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U.S. Department of Health and Human Services

Drugs

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Federal Register Notice (70FR3937) (issued 1/27/ 2005)

[Federal Register: January 27, 2005 (Volume 70, Number 17)]
[Notices]
[Page 3937]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27ja05-62]

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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. This list adds to the previously
published lists prioritizing drugs most in need of study for use by
children to ensure the safety and efficacy of their medication. 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. Tamar Lasky, National Institute of
Child Health and Human Development (NICHD), 6100 Executive Boulevard,
Suite 5C01G, Bethesda, MD 20892-7510, e-mail
BestPharmaceuticals@mail.nih.gov, telephone (301) 594-8670 (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, Pub. L. 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 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.
The following off-patent drugs were reviewed by expert consultants
at an October 25 and 26, 2004, scientific meeting at NICHD and
recommended for further study: Ivermectin for scabies; hydrocortisone
valerate ointment and cream for dermatitis; hydrochlorothiazide for
hypertension; ethambutol for tuberculosis; griseofulvin for tinea
capitis; methadone for opiate addicted neonates; hydroxychloroquine for
connective tissue disorders.
The following off-patent drugs were recommended for re-labeling
based on evidence available in the literature: Acyclovir for herpetic
infections.
The following off-patent drugs were recommended for systematic
literature review and/or further consultation with scientific community
to finalize scientific questions in need of study: Cyclosporine for
heart transplant patients; clonidine for autism, attention deficit
disorder; flecainide for life threatening ventricular arrhythmias.
The following on-patent drugs were referred to the NICHD by the
Foundation for NIH, reviewed by expert consultants at the October 25
and 26, 2004, scientific meeting, and recommended for further study:
Sevelamer for renal failure; morphine for analgesia.
The following on-patent drugs were recommended for systematic
literature review and/or further consultation with the scientific
community to finalize scientific questions in need of study: Bupropion
for depression.

Dated: January 19, 2005.
Elias A. Zerhouni,
Director, National Institutes of Health.
[FR Doc. 05-1495 Filed 1-26-05; 8:45 am]
BILLING CODE 4140-01-P