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Last Updated: 02/01/2018

Article of Interest - Medication

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Bridges4Kids LogoBill 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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