DRUG TESTING IN CHILDREN: FDA REGULATIONS

The testillg of drugs for use ill cilildren is difficult to accomplish, and it is even difficult to write about. Anything that smacks of "experimentation" on a child or even the use of a placebo given to a sick child is an emotionally charged subject. To carry out procedures that cannot be considered as essential to therapy, especially when they are painful or tiresome, seems abhorrent. However, it is recognized that the effects of many drugs on children may vary considerably from the effects on adults even when careful calculation is made to arrive at a dosage proportional to the body weight or estimated body surface area. Pharmacologically, children cannot be regarded as little adults. Intensified, or toxic effects of drugs administered to children, especially infants, may reflect immaturity in enzymatic mechanisms for drug metabolism, as well as other detoxification and excretory functions. In view of these circumstances, there is need for special caution in prescribing medication in the treatment of childhood disorders, particularly when the medication is used for an extended period of time or when a newly marketed drug is employed. Even greater caution is needed with the use of a new drug under investigation, in advance of approval for marketing. Known serious adverse effects of drugs in children include the effects of sex hormones on growth, steroids on genital development, and antibiotics on tooth enamel. According to the regulations of the Food and Drug Administration, a drug which has not been subjected to investigation in children may not be labeled for use in pediatric therapy.