As President Clinton moved Wednesday to prod drug manufacturers into finding child-safe dosages for medicines, industry representatives politely suggested he was late to the game.
A proposed new Food and Drug Administration rule unveiled with fanfare by Clinton, the first lady and Vice President Al Gore would require makers of prescription drugs to test for safe use by children - and to put child-appropriate dosages on the label.
“Without clear guidance, pediatricians sometimes decide not to prescribe for children drugs used successfully by adults. This means children may well be deprived of the very best treatment available,” Clinton said.
“The pediatrician’s other alternative is to guess, with potentially grave consequences.”
White House officials said 10 drugs already on the market were inadequately tested for children.
But Alan Holmer of the Pharmaceutical Industry Manufacturers Association contended the administration’s argument was drawn from 1994 data and that testing of most of the 10 drugs was begun in the last three years. In the case of Ritalin, Holmer said, a pediatric dose already appears on the label.
“This is an area the companies have already focused on and there’s been significant activity, so we question whether a government mandate is needed,” he said.
“But we do welcome the energy the president now brings to the process.”
Invited guest Reagan Ralph lamented that her 2-year-old son’s pediatrician has had to guess on dosages for his asthma medication.
“She should have been able to rely on a proper pediatric label,” Ralph said in the Old Executive Office Building, where the event had been moved under threat of rain. Her son, Sam, threatened another kind of outburst until, to the audience’s delight, he was allowed to claim the seat between the president and first lady Hillary Rodham Clinton.
The proposed rules do not require massive clinical trials in children. Instead, a drug that previous studies indicated would be safe in adults would be tested solely to determine the proper dose for children. The FDA estimated the additional testing would cost manufacturers between $13 million and $20 million, or about 1 percent of total development costs.
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