http://www.democrats.org/news/200203200002.html

Mar 20, 2002
 
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Bush Administration Suspends Rule Making Prescription Drugs Safer for Children

The Bush administration has decided to suspend a rule that requires pharmaceutical companies to test whether their products are safe for children. The change by the Food and Drug Administration rolls back a 1997 rule implemented by the Clinton Administration that ensured doctors have the information they need when prescribing prescription drugs to children.

Doctors' groups, including the American Academy of Pediatrics, blasted the Bush administration decision. They claimed that allowing drug companies to decide when they will test their products for safety in children will make it more difficult for doctors to judge which drugs -- and at what dosages -- are safe for children. Robert Ward, a spokesman for the American Academy of Pediatrics, gave the example of Priscoline, a drug for hypertension which was given to infants in dosages based on estimates. Those dosages were later found to be strong enough to stop infants' hearts.

Senate Democrats criticized the FDA's decision. "It appears the FDA has put up the white flag of surrender, leaving children exposed to products that have not been tested for their use," said Senator Hillary Clinton (D-NY). And Senator Ted Kennedy (D-MA) said the decision to suspend the rule "makes no sense." [Washington Post, 3/19/02]


 

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