Important note: Information in this article was accurate in 2003. The state of the art may have changed since the publication date.
Associated Press - December 4, 2003
Now, only a fourth of the drugs on the market are tested and properly labeled for safe use in children. Because children and adults react to drugs differently, calculating the amount of medicine children should take based on what is appropriate for adults can lead to either overmedication or under-medication.
The bill is aimed at eliminating that guesswork for doctors.
In 1988, the Food and Drug Administration issued the "pediatric rule" to give itself the authority to require tests on adult drugs that are prescribed more often for children. Last year, a federal court ruled that it was up to Congress to give the FDA the authority it needed.
The new law ensures the FDA can require testing of medicine dosages for children, even when drug companies lack the financial incentives to voluntarily do so. It also expands on 1997 legislation that extended the length of the patent rights of pharmaceutical companies that volunteer to conduct pediatric studies to develop labeling standards for children.
The law applies to all medications, such as vaccines, whose intended use for children is the same as that for adults.
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