[Federal Register: January 21, 2003 (Volume 68, Number 13)]
[Notices]
[Page 2789-2790]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21ja03-78]
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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 annually until the Act
expires on October 1, 2007.
DATES: The list is effective upon publication.
FOR FURTHER INFORMATION CONTACT: Dr. Donald Mattison, National
Institute of Child Health and Human Development, 6100 Executive
Boulevard, Room 4B-100, Rockville, MD 20892, e-mail
BestPharmaceuticals@mail.nih.gov, telephone 301-496-5097
(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
[[Page 2790]]
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 initial list, 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 off-patent
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.
Following is the list of drugs for which pediatric studies are most
urgently needed:
Azithromycin
Baclofen
Bumetanide
Dobutamine
Dopamine
Furosemide
Heparin
Lithium
Lorazepam
Rifampin
Sodium Nitroprusside
Spironolactone
Dated: January 9, 2003.
Ruth L. Kirschstein,
Deputy Director, NIH.
[FR Doc. 03-1250 Filed 1-17-03; 8:45 am]
BILLING CODE 4140-01-M