Regulatory Issues

U.S. Congress Revamps Program To Study, Label Children's Drugs

Published in Medical Letter on the CDC and FDA, February 17th, 2002

In the past, doctors for the 5% of children who receive kidney transplants each year would have had to use body weight as their guide to calculate the proper dosage. Now, incentives given by the U.S. Congress to drug companies have prompted them to study pediatric dosages for prescription medication, including the immunity-suppressing drug given to pediatric transplant recipients.

In December 2001, Congress approved an updated version of the program, allowing it to expand and continue 5 more years.

"If the typical adult takes 2 milligrams and [a child] is half the size of an adult, we would have estimated that he would need 1 milligram," said John...

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Source: Medical Letter on the CDC and FDA (2002-02-17)

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