Industry Slams Plan To Test Drugs In Children

In the USA, drug companies are claiming that President Clinton's Augustproposal requiring them to test new drugs in children before they are approved would needlessly put many children at risk, and also that the government has no legal authority to make them conduct these studies. Even federal officials now feel that the proposal raises some ethical questions, the New York Times notes.

The plan would require firms whose products were used or were likely to be used in a substantial number of pediatric patients to test their drugs in children; it would also apply to drugs offering meaningful therapeutic benefits over existing pediatric treatments. The Food and Drug Administration would be authorized to seek court orders requiring companies to study how their products affect children, with violators subject to fines and other penalties.

Pharmaceutical Research and Manufacturers of America president Alan Holmer said the plan was good-intentioned but could harm children because it would require testing of new compounds in them before safety in adults had been studied adequately. Testing in children should wait until there is clear evidence that a product is safe and effective in adults, he said, and requiring simultaneous testing in adults and children could delay drug approvals for adults. There is concern that children injured in testing might file lawsuits years later even though their parents consented to the tests, and how researchers can get informed consent from children as they do from adults.