[Federal Register Volume 70, Number 17 (Thursday, January 27, 2005)]
[Notices]
[Page 3937]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-1495]


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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 
[email protected], 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