Your editorial“FDA must revisit OxyContin decision’’ (Feb. 7) mischaracterizes the Food and Drug Administration’s action to label OxyContin for children. Seriously ill children, such as those suffering from sickle cell disease and cancer, can benefit tremendously from OxyContin. Effective opioid pain management can mean the difference between being bedridden and going to school.

Drug development most often occurs first for adults, leaving pediatricians unsure about whether a drug is safe or effective in children or what dose is most appropriate. The FDA’s approval of OxyContin labeling for children ages 11 to 16 was not necessary to authorize its use in children, as your editorial states, since the drug was already being prescribed off-label. What your piece fails to mention is that, because many medicines are still not appropriately studied in children, pediatricians often have no choice but to prescribe medicines without the benefit of data on its use in children. Children deserve the highest possible level of evidence to guide their use of medicines.

Further, we disagree with the suggestion that the FDA was required to convene a panel for this approval, though we are confident that such a panel would have supported the decision. We do not believe that this labeling will lead to an increase in inappropriate prescribing. In addition, the Senate should act quickly to confirm Dr. Robert Califf to lead the FDA; his confirmation should not be delayed over misguided criticism of the agency’s decision on OxyContin.

Pediatricians share concern about the devastating toll opioid addiction has taken on our nation, and since addiction frequently starts in adolescence, we understand firsthand its grave consequences and recognize the need for immediate and comprehensive action. The solution, however, is not to deny doctors the crucial information they need to safely prescribe effective treatments for severe pain in children.

Dr. Benard P. Dreyer

President

American Academy of Pediatrics

New York