Collaboration in Regulatory Science to Facilitate Therapeutic Development for Pregnant Women.

Abstract

Therapeutic tragedies of the past, ethical concerns, and legal risks, among other factors have led to a conservative approach to clinical research during pregnancy, resulting in a de facto exclusion of pregnant women from most clinical therapeutics trials. As a result, there is a deficit of knowledge regarding the safety and proper dosing of medications during pregnancy, leaving prescribers with limited information available to support clinical decision-making. Additionally, there is little development of treatments for pregnancy-specific conditions. This review describes the current need for therapeutic development in pregnant women, summarizes the history of regulations impacting this research area, and describes current efforts to increase the information used to help make decisions regarding the use of drugs during pregnancy and lactation. This is a brief review of the literature, federal regulations, and policies on research in pregnant women. While therapeutic development in pregnant women has been limited in the past, recent efforts by academic researchers, bioethicists, industry, advocacy groups, and federal agencies have sought to enhance strategies to increase the participation of pregnant women in clinical research that may benefit them and/or their fetus. Collaborative efforts from all stakeholders, including industry, academia, advocacy groups, regulators, and other governmental agencies, if successful will increase the information needed to help make decisions regarding the use of drugs during pregnancy and lactation.