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Journalism of Courage
WASHINGTON, Aug 14: President Bill Clinton ordered the nation’s drug-makers to test whether the medicines they sell to adults are safe and effective for children and to put the dosages on the label.
At a White House ceremony on Wednesday, Clinton proposed to the Food and Drug Administration a set of rules that would require manufacturers to promptly provide relevant information for children on the labels of new drugs.
He said it is unacceptable that so many medicines that prove useful for sick children have not been approved for them, and that pediatricians often are left to estimate appropriate dosages for children, “with potentially grave consequences.”
First Lady Hillary Rodham Clinton, a longtime advocate for children, recalled the struggles of the late AIDS activist Elizabeth Glaser to obtain aids medication for her daughter, Ariel.
“Elizabeth’s struggle … Made clear a heartbreaking problem,” Hillary Clinton said. Now, she said, “no child or parent would have to endure this kind of agonizing uncertainty.”
About 80 per cent of the prescription drugs are not labeled for children’s use because they never were tested in children. Desperate pediatricians often must guess a safe dose when they have to use adult drugs such as asthma or AIDS medications on their smallest patients.
The drug industry has largely ignored previous efforts by the Food and Drug Administration, designed to spur more children’s prescription information.
