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Notice

List of Drugs for Which Pediatric Studies Are Needed

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Information about this document as published in the Federal Register.

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ACTION:

Notice.

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.

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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).

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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.

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Dated: January 19, 2005.

Elias A. Zerhouni,

Director, National Institutes of Health.

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[FR Doc. 05-1495 Filed 1-26-05; 8:45 am]

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