Questions and Answers on Labeling of Drugs for Children
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QUESTIONS AND ANSWERS ON LABELING OF DRUGS FOR CHILDREN JOHNT. WILSON, MD Louisiana State University Medical Center, Department of Pediatrics, Section on Clinical Pharmacology, Shreveport, Louisiana
A brief review of pediatric off-label prescribing reveals a need for remedial action. Real
and presumed impediments to acquisition of clinical trial data in children are examined. Many impediments are found to lack substantive merit and fail to offer cause for not undertaking pediatric clinical trials. Recent legislative, and Food and Drug Administration (FDA) and National Institutes of Health (NIH) actions, offer remedial measures to increase labeling of drugs for children and thus decrease off-label prescribing prevalent for 30 years. Key Words: Pediatrics; Off-label prescribing; Clinical trials
DILEMMA OFF-LABEL PRESCRIBING (Off-label prescribing is defined as use of a drug for an indication or in a population, for example, children, for which FDA approved labeling does not exist in the package insert.) for children is a dilemma first described in 1968 (1), and validated in 1975 (2) and 1992 (3); it persists today (4,5,6) despite remedial strategies proposed from 1971 to 1996 (7-10). Prevalent in drug labeling is a child age disclaimer. This and a lack of FDA approved labeling for indications specifically in children constitute the basis for a drug used either off-label or withheld from the child even though FDA approved indications for adult use are similar to indications in the child. Neither alternative is entirely acceptable. Ac-
Presented in part at the DIA Workshop “Pediatric Drug Development: Success and New Solutions,” April 2021, 1998, Arlington, Virginia. Reprint address: John T. Wilson, MD, Louisiana State University Medical Center, Department of Pediatrics, Section on Clinical Pharmacology, 1501 Kings Highway, Shreveport, LA 7 1130, e-mail: cwebb@ Isumc.edu.
cordingly, this article addresses two expositions which assist an understanding of the dilemma:
1. An historical background on pediatric drug labeling, and 2. Questions and answers which offer resolution of pediatric off-label prescribing through support of clinical trials and analysis of existing data. BACKGROUND Little change has occurred in the putative 80% (2,3) of drugs not labeled for use in children. This lack of pediatric labeling was first demonstrated from analysis of 2000 drugs in the 1973 Physicians’ Desk Reference (PDR) (2), and was again found in the 1991 PDR (3). In 1995, 28 New Molecular Entities (NMEs) were approved and of the 20 deemed likely for use in children, only four were approved for pediatric labeling (20%) (6). The deadline of December 31, 1996 for compliance with the 1994 FDA revised pediatric rule (1 1) was extended to secure an increased response from more phar-
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John T. Wilson
maceutical companies to prepare plans for pediatric labeling. Analysis of
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