Pregnancy and medicines: time for paradigm change

Overview

There is a persistent scarcity of data to support clinical decision making regarding approval and use of drugs, biologics and vaccines in pregnant people, putting them at risk of inadequate, inappropriate or unsafe therapy, which can result in significant health consequences for the mother and her child. In recent years, a number of governmental and non-governmental organizations have begun to advocate for change in the existing paradigm of medicines development to ensure that women and their health providers can make informed choices about the treatment they need, based on
data. The World Health Organization (WHO) and International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network convened a Workshop on approaches to enhance investigations of new drugs in pregnant women in May 2020, which included discussions on the regulatory framework. Building on the outcomes of the discussion, we propose how to leverage the existing regulatory framework and introduce innovations to support earlier investigation of drugs in pregnant and breastfeeding women.

Read the full article

Published in the Journal of the International AIDS Society (JIAS) Volume 25, Issue S2