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Published: Sunday, 11/23/2003

A victory for children

As the winter closes in, parents will inevitably head into their pediatrician's office at some point with a sick child. It's an anxious time for all concerned. But at least congressional action spearheaded by Sen. Mike DeWine will give parents more peace of mind in the future when they fill pediatric prescriptions.

In a victory for children's health care, Congress has approved a measure that should go a long way toward taking the guesswork out of prescribing medicine for kids. It gives the Food and Drug Administration authority to require drug companies to test medicines specifically for children.

The legislation basically reinstates the FDA's old Pediatric Rule, established in 1998, to ensure that medicines prescribed for children are safe to use. A federal court struck down that FDA regulation, saying the agency didn't have the authority to make such demands.

Now it does. The change is necessary because roughly 75 percent of all drugs prescribed for children are not tested for use by children. They're designed and tested for adults.

But kids and adults react to drugs in different ways and until now there has been no way to precisely calculate what dosage of commonly prescribed adult medicine will be most safe and effective in children.

Doctors have been dispensing pediatric prescriptions through trial and error for years, hoping the dosage wouldn't under-medicate or overmedicate their young patients.

Congress had previously given pharmaceutical firms the voluntary option of testing their drugs for pediatric use and sweetened the prospect with financial incentives. Some took advantage of the patent exclusivity provisions to offset the cost of conducting pediatric test trials. Many did not.

But now under the Pediatric Research Equity Act, the FDA can require drug companies to conduct the tests. The authority applies to all medications, such as vaccines, whose intended use for children is the same as that for adults.

The forthcoming information about the effect of drugs on children is welcomed and way overdue. “It was a long fight,” said Senator DeWine, “but finally the FDA has all the tools it needs to ensure that the medicines we give our children do what they were intended to do - ease their pain or make them healthy.”

What more could a parent or pediatrician want?



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