Are the drugs on the market without labeling for pediatric indications being used illegally?
A. No, doctors may legally use approved drugs for whatever uses they think appropriate, according to their medical judgment. Q. As a pediatrician, you must be concerned. What sort of things is FDA doing to make more drugs available for children? A. We’re doing a number of things to be active in this area and are about to launch a plan for more. As we meet with drug companies to discuss the drugs they are studying, we are encouraging them to test those drugs in children when appropriate. We are finding that companies are often responsive to the need. We are changing our internal procedures to foster the availability of new drugs for youngsters. We routinely ask our FDA drug review divisions to sift through their INDs [the formal requests to test a new drug] to identify drugs that might show particular promise in children. It is these drugs with potential pediatric uses that we encourage drug companies to develop for children, either before or after approval for use in adults. We have cr
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