Needs and new Policies For Medicines for Children: The FDA, United States Incentives, and International Doings
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Drug Information Journal, Vol. 34, pp. 203-205, Z o o 0 Printed in the USA. All rights reserved.
NEEDS AND NEW POLICIES FOR MEDICINES FOR CHILDREN: THE FDA, UNITED STATES INCENTIVES, AND INTERNATIONAL DOINGS PAULABOTSTEIN,MD Consultant, Botstein Associates, Bethesda, Maryland
Most prescription medicines in the United States and in other countries are not labeled with sufficient information for sensible use in the pediatric population, even though many drugs are widely used for disorders present in both children and adults. The Food and Drug Administrafion(FDA) has launched initiatives to get pediatric use information into labeling of medicines in the United States: a 1998 regulation requiring that drugs be studied in the pediatric population; marketing exclusivity for obtaining pediatric data; and a 1994 labeling regulation allowing use of adult safety and effectiveness data as a basis for pediatric use of drugs. Harmonization of international pediatric drug policies and regulations could increase the global availability of drugs labeled for pediatric use. The goal is greater availability worldwide of information on pediatric dosing, pharmacokinetics, and avoidance of safety problem. Key Words: Pediatric; FDA; International; Clinical study
INTRODUCTION
for the diagnosis and treatment of disease. Most prescription medicines in the United States and in other countries are not labeled with sufficient information for sensible use in the pediatric population, even though many drugs are widely used for disorders present in both children and adults. Of new molecular entities with potential pediatric use, fewer than half approved for marketing in the United States during the 1990s have had pediatric labeling at the time of initial marketing. For drugs marketed in earlier years, one can look in the Physician’s Desk Reference
Presented at the 35th DIA Annual Meeting, June 27July 1, 1999. Baltimore, Maryland. Reprint address: Dr. Paula Botstein, Botstein A ~ ciates, 6219 Wagner Lane, Bethesda. MD 20816.
(PDR) to see that relatively few have information about use in the pediatric population. Physician labeling of medicines used by children in Europe, Australia, Japan, and many other parts of the world often does not give information necessary for use in children; the predicament of these therapeutic orphans is no different there.
FDA’S 1998 PEDIATRIC REGULATION The Food and Drug Administration has launched initiatives to get pediatric use information into physician labeling of medicines in the United States. The newest is a 1998 rule requiring that drugs be studied in the pediatric population (1). This rule establishes the presumption that drugs will be studied in ~children. ~ - It COVerS new molecular entities, new dosage forms, and new routes of admin-
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istration. It applies to drugs in development and to marketed drugs. The long-term solution for getting drugs labeled with information for use in children is through studying drugs in the pediatric population as they are developed for use in adults. This reg
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