Mar 20, 2002
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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