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FDA Encourages Pediatric Information on Drug Labeling

By Patrick E. Clarke, Office of Communications


A mother discusses pediatric drug labeling with a pharmacistChildren are not young adults when it comes to dosing medications. In 2008, an estimated 211,209 emergency room visits for adverse reactions to medications or nutritional products were made by children age 12 or younger, according to the Substance Abuse and Mental Health Services Administration. Factors affecting growth, metabolism and development may result in adverse pediatric events even though the drug is safe for use by adults. Due to the complexity of these factors, differences in how a drug works may not be predictable and therefore, just changing the adult dose based on the weight or age of a child may not be appropriate. 

Legislation Effective in Increasing Pediatric Information

Since pediatric information was often missing from drug labeling, Congress passed the Best Pharmaceuticals for Children Act (BPCA) in 2002 and the Pediatric Research Equity Act (PREA) in 2003.  BPCA reauthorized a provision that was originally contained in the Food and Drug Administration Modernization Act of 1997 (FDAMA) in 1997. These pediatric initiatives have resulted in new pediatric labeling for almost 400 drugs as of March, 2011.

These two laws complement each other.  BPCA (often called the “carrot”), provides a financial incentive (pediatric exclusivity) to pharmaceutical companies that test drugs with remaining patent life in pediatric patients. In addition, this Act creates a process by which FDA and the National Institutes of Health (NIH) can partner to obtain studies of off-patent drugs in pediatric patients.  PREA (the “stick”) requires pediatric assessments of new drug and biologic licensing applications for all new active ingredients, indications, dosage forms, dosing regimens, and routes of administration. A pediatric assessment must contain sufficient data to allow information about pediatric use to be put into drug labeling.    

The pediatric exclusivity incentive enables FDA to grant six months of marketing exclusivity to sponsors that complete voluntary pediatric studies in accordance with a Written Request issued by the Agency.   A Written Request is a type of contract that describes the type of studies needed to be performed in order to get enough information to label a product in pediatric patients. 

There is still much to be done regarding pediatric drug development. Not all drugs that are effective in adults can be shown to be effective in children. Safety must always be studied in pediatric patients because children may be more sensitive than adults to adverse reactions or unexpected adverse events not typically observed in adults may occur. In addition, the effects of a drug on the growth and development of a child also may need to be considered.