FDA Official Comments on Data

Thomas Laughren, M.D., acting director of the FDA Division of Psychiatry Products within the Center for Drug Evaluation and Research, told Psychiatric News via e-mail that despite formal requests from both APA and the AMA, the FDA “has not systematically tracked antidepressant prescribing in the pediatric population since” the black box was added to the labels of all antidepressants marketed in the U.S.

Psychiatric News asked Laughren to comment on the data from NDC Health on antidepressant prescriptions and what impact—if any—the data might have on the FDA's efforts to label antidepressants appropriately.

“For the sake of argument,” Laughren responded, “let's assume that the NDC Health data do accurately reflect a decline in antidepressant prescribing in the pediatric age group. There would be no easy interpretation of such a finding, in isolation.

“A decline in prescribing might be an indication of a decrease in access to these medications for patients who may benefit, but alternatively, it could be a reflection of more rational prescribing that is consistent with a more appropriate risk-benefit model.

“Even tracking suicidal behavior in this population is not a failsafe approach to assessing the impact of this labeling change, because secular trends in such behavior are influenced by many different factors.

“Labeling language is of course a dynamic process that is subject to change in the face of new knowledge. However, we feel that the type of data most likely to have an impact on future changes of the labeling language with regard to suicidality would be systematically collected data that better define the risks and benefits of these drugs in the pediatric population than have the studies done to date.”

Laughren closed his e-mail by stating, “It is possible that other sources of evidence could have an impact on the FDA's thinking about appropriate prescribing of antidepressants in the pediatric population.”