October 1997
WASHINGTON, D.C. — New Food and Drug Administration (FDA) regulations recently proposed by President Clinton will require pharmaceutical manufacturers to include proper drug labeling of drugs used for children.
"Drug companies must now show dosing for children on the labels," said Laura Bradbard, FDA spokeswoman from the Center for Drug Evaluation and Research. "Most of the companies already have the data they need, they just have to analyze it for kids."
Approximately 80% of all drugs marketed in the United States have not been labeled for use by infants, children and adolescents. Only 42% of drugs widely used in pediatric populations have been actually tested on children, according to the FDA.
This often means that pediatricians must guess the appropriate child dosage. However, the new FDA ruling will require pharmaceutical manufacturers to study the safety and appropriate dosage levels of medications for pediatric populations.
"Adults have had the benefits of testing and labeling for over half a century," said Joseph R. Zanga, MD, American Academy of Pediatrics (AAP) vice president. "For children, we label the food they eat and the television shows they watch. However, when it comes to prescribing children’s medicine, information about how much and how often to give it to them is sorely lacking."
Although the FDA regulation would request additional studies for pediatric drug indications, the FDA said it would not delay approving a drug for adults, and that pediatric labeling could be added soon after sales to adults began — as long as it is done in a timely fashion.
The proposed rules do not require expensive clinical trials in children, according to the FDA. If previous studies indicated the drug is safe in adults, the pediatric tests would simply be to determine the proper dosage for children.
"Children are basically therapeutic orphans," said AAP spokesman Ralph Kauffman, MD, during congressional testimony given last fall. "We need to make them equals, instead of afterthoughts, in the process of research, approval and labeling on drugs."
Kauffman is a pediatrician from Kansas City, Mo., and former chairman of the AAP Committee on Drugs.
The proposal was recently published in the Federal Register and the FDA encourages comments on the proposal.
Provisions of Proposed Rule |
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New drugs would require pediatric studies when the product represents a meaningful therapeutic benefit over existing treatments or when the product is expected to be widely used on pediatric patients. Under the following certain circumstances, manufacturers could receive waivers from the requirement to do a pediatric study:
For drugs already on the market, the proposed regulation would require additional testing on the pediatric populations only if there is a compelling need for more information. The criteria for more testing on available products would include:
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