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FDA changes rules on testing drugs for children

by Medindia Content Team on  April 17, 2002 at 10:47 AM Drug News   - G J E 4
FDA changes rules on testing drugs for children
The FDA is suspending a rule that lets the government require safety testing of adult medicines commonly given to children, a move that has drawn the ire of some Democratic lawmakers. FDA says Congress recently reauthorized financial incentives for manufacturers to do those studies. The FDA said it wants to see if the new law makes the old mandate, which drug makers hated, unnecessary.
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But three Democrats complained to President Bush that the action was halting "an important regulation that protects children from potentially unsafe and improperly dosed medications."

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Adult medications are commonly given to children without studies of their safety or proper dosing because doctors have no alternative. Drug makers have used the financial incentives to focus their studies on more expensive drugs, like Prozac, rather than cheaper ones that no longer have patent protection.

The FDA's so-called "pediatric rule" was adopted in 1998. The new Best Pharmaceuticals for Children Act, signed into law in February, reauthorized the financial incentives, plus set up a grant program to allow taxpayer dollars for pediatric studies of drugs their makers, despite the incentives, won't do. During a two-year suspension of the older mandate, the FDA will assess if the new law takes care of the problem.
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