The engine driving the amazing progress in new therapeutic agents in the late 20th century has been the major pharmaceutical companies, which in turn are fueled by the desire to make profits for their stockholders. With a few exceptions, like oral antibiotics and antihistamines, children and new drugs for pediatric indications are too small a market to draw the attention of the major pharmaceutical houses, and the profit motive fails to provide the necessary impetus to perform the studies needed to understand how to use new drugs in children. To rectify this imbalance, Congress and the Food and Drug Administration (FDA) have tried a variety of tacks. In 1979, the FDA began to require pediatric information in the product label and package insert, but this did little to motivate pediatric studies. In 1994, the FDA allowed companies to obtain pediatric labeling if they established a dosing regimen for children and...

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