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 Bill
Seeks Right Dose For Kids
Detroit Free Press and the Associated Press, November 20,
2003
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The government
could require drug companies to test medicines to assure that
dosages are appropriate for children under legislation given
final congressional approval Wednesday.
The measure, passed by the House on a voice vote, is aimed at
eliminating the guesswork for doctors who prescribe for children
medicines that have been tested only for adults. The bill
already had passed the Senate.
FDA Commissioner Mark McClellan and Health and Human Services
Secretary Tommy Thompson, in a joint statement, welcomed passage
of the bill. "Children are a unique population with special
medical needs," they said.
The legislation was sponsored in the Senate by Sen. Mike DeWine,
R-Ohio. It expands on 1997 legislation that extended patent
rights time periods for pharmaceutical companies that
volunteered to carry out pediatric studies to develop labeling
standards for children.
In 1998, the Food and Drug Administration issued what it called
the pediatric rule, giving the FDA the authority to require
tests for adult drugs prescribed more often for children. But
last year, a federal court struck down the rule, stressing that
it was up to Congress to pass legislation giving the FDA the
authority it needed.
The legislation would ensure that the FDA can require testing on
children when drug companies lack the financial incentives to
voluntarily conduct testing.
It applies to all medications, such as vaccines, whose intended
use for children is the same as that for adults.
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