Protecting Mothers and Babies Through Research: A Time for Change

ABSTRACT

Pregnant patients deserve access to curated information that informs them on the safe use of medicines to treat or prevent disease. Limited or absent drug information can lead to unsafe use of medicines or even refusal or reluctance to prescribe or receive treatment. Decisions not to treat or inadequately treat comorbid conditions during pregnancy can pose significant health risks to mothers impacted by these decisions and their babies. Experiences gained during the SARS-CoV-2 pandemic that found a higher risk of hospitalization and death in pregnant populations have accentuated the need for targeted efficacy and safety data to optimally treat or prevent disease during pregnancy. In the United States, Congress has previously recognized that the lack of information within drug labels to convey certainty in prescribing medications during pregnancy is an urgent public health issue. Similarly, regulatory agencies such as the Food and Drug Administration acknowledge the role that data evaluating drug disposition, pharmacology, and disease biology play in reducing regulatory uncertainty and informing decisionmaking for the good of public health. Historically, in the absence of labeled drug information, networks such as MotherToBaby, have become the trusted expert source providing evidence-based information on the benefit or risk of medications and other exposures during pregnancy. To facilitate the more timely generation of data to inform the use of medicines in pregnancy, multistakeholder initiatives such as the Task Force on Research in Pregnant Women and Lactating Women (PRGLAC) have been established to identify gaps and provide findings to Congress for action. These initiatives have identified a set of opportunities to address the many challenges contributing to the disproportionate exclusion of pregnant populations in clinical trials. As a complimentary mechanism, broader reforms could be considered to foster a research culture that is purposeful and inclusive of pregnant patients. Together, these approaches can reduce uncertainty in prescribing in pregnancy and better address the needs of mothers and their babies.