We commend the authors reporting on the Centers for Disease Control and Prevention–sponsored meeting to develop a priority setting, evidence review, and consensus recommendation structure to advance safer medication use during pregnancy. However, several key issues received either scant or no mention in their report. The Food and Drug Administration (FDA) classification of drug use in gestation (categories A-D and X) was criticized as a system with which “oversimplification might result in incorrect conclusions.” Indeed, the FDA (itself represented at the meeting) recognized the need for a better approach and proposed major rule changes that would favor more nuanced and informative labeling in 2008.

Unfortunately, despite being labeled an “agency priority” to be written and cleared “as efficiently as possible,” no published updates leading to a final rule have appeared since 2011. Is a conclusion anywhere in sight? Further, while systematic reviews are often helpful, a larger concern is that information will be occasionally limited and frequently incomplete. This seems an understatement regarding the still shameful lack of well-designed and adequately powered studies that focus on optimal prescribing, maternal efficacy, and fetal safety of drugs in pregnancy, which is a void that has been recognized for decades. A more explicit plea by the authors for this needed research would have been welcome. Finally, although represented at the meeting, there was no mention of the National Institute of Child Health and Development–supported Obstetric-Fetal Pharmacology Research Units network, whose limited, but much needed, work focuses not on teratogenesis but more broadly on rational pharmacotherapy across the span of pregnancy, which includes safety, efficacy, dosing, and the risks of under-treated maternal disease. Again, our congratulations to the authors; we all look towards needed progress in this area.