Labeling for pediatrics

FDA has proposed a rule requiring drug manufacturers to test the safety of some new prescription drugs and biologics for children, determine appropriate dosages and label the product accordingly.

The regulations would apply to new drugs likely to be prescribed for children. For drugs already on the market, manufacturers would submit pediatric information if there were "compelling circumstances." Where adults and children are similarly affected by a disease, the drugs would have to be tested for safety and dosage, but not effectiveness. There has been growing concern over lack of pediatric testing of drugs often given to children and lack of information on drug labels to help doctors prescribe appropriate dosages. FDA acted after industry failed to adequately support a voluntary system launched in 1994. According to the agency, the percentage of drugs tested on children is decreasing. Its investigations revealed that only 20% of drugs on the market have been tested on children and only about 40% of those considered highly beneficial for children have been tested. Many of these drugs are used to treat common illnesses including asthma, ear infections and allergic reactions. The rule would take effect sometime after the 90-day public comment period which ends in November. Manufacturers submitting applications for new drugs would have between 15 and 21 months to provide pediatric studies.

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