Every year more than half of newly approved drugs that are likely to be used in children lack information to permit safe and effective use. Without adequate information, doctors may be unwilling to prescribe certain drugs for their pediatric patients, or they may prescribe them improperly. However, if doctors decide against using adult drugs in their young patients because the proper dose is unknown, children may be deprived of useful treatments.
To resolve this, FDA finalized regulations, which require manufacturers of many drugs to provide information about how their drugs can safely and effectively be taken by children (from newborns to adolescents). This will give health-care practitioners specific dosing information–based on scientific evidence–which will make prescribing for children safer and better. Since doctors will have more complete information on how drugs affect children and what appropriate doses are needed, it enables children to receive better treatment.
For drugs already approved, FDA can require children’s studies to be conducted in certain circumstances–for example, when pediatric information can help avoid serious risks to kids. Government regulations allow FDA to waive sending in pediatric data completely (under certain circumstances), or to submit data after a drug has already been on the market, if FDA has safety concerns about testing the drug on children prior to testing it on adults. FDA, however, will not delay approving a drug for adults if the pediatric studies are not yet completed.
