AP – President Bush on Wednesday signed legislation giving the government the ability to require drug companies to test medicines to
ensure that dosages are appropriate for children.
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.