Rules To Make Child Doses Common On Drug Labels Most Prescription Medicines Never Tested In Kids, Leaving Pediatricians To Guess Dosage
The Clinton administration is preparing to force drug manufacturers to test whether the medicines they sell to adults are safe and effective for children to use, too.
About 80 percent of the nation’s prescription drugs are not labeled for child 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 Food and Drug Administration efforts dating back to 1994 designed to spur more children’s prescription information.
Now, President Clinton is set to propose regulations today that would require manufacturers to provide that information for new drugs promptly - or face the FDA in court.
Donna Shalala, the secretary of Health and Human Services, would not confirm specifically what Clinton will propose but told reporters, “It will be one of those things … that everyone who has a kid will understand and say, ‘Gosh, that’s a good thing to do.”’
Officials familiar with the rules, who spoke on condition of anonymity, say that when a company seeks FDA permission to test an experimental drug in adults, the agency would decide whether it has potential for children. If so, the company would be ordered to provide a plan for determining the safe child dose.
The FDA would not delay approving a drug for adults, stressed one administration official. Pediatric labeling could be added soon after sales to adults begin, as long as the move is timely, the official said.
The proposed rules do not require massive, expensive clinical trials in children. Instead, if a drug is considered safe in adults, companies could do simple dosage testing - studies that take three to six months to perform - to show the dose that gets a therapeutic level of the medicine into a child’s bloodstream.
“People assume any drug that is prescribed for their children has been tested, and that’s not the case,” said Susan DeLaurentis of the Pediatric AIDS Foundation. “This will now be a requirement.”
The proposed rules also would require existing adult drugs that are widely prescribed to children - such as bronchodilators for asthma patients or the antidepressant Prozac - to have the pediatric dose added to the label. But a deadline on that was not immediately set.
Of 183 drugs approved in the last five years, only 44 were quickly labeled to include child prescription information. The FDA targeted 64 more drugs that offered promise for children, but only two ultimately were labeled for children, the AIDS foundation said.