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Manufacture Clinical Trials, Standards & Regulation, Small Molecules

A Tall Task

The Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) was mandated in 2016 by the 21st Century Cures Act (1). PRGLAC was charged with providing advice and guidance to the Secretary of Health and Human Services (HHS) on activities related to identifying and addressing gaps in knowledge and research on safe and effective therapies for pregnant and lactating women. In other words, what can researchers, health care providers, and medical professionals do to ensure that pregnant women and nursing mothers receive appropriate doses of medications?

More than six million women are pregnant in the United States each year, and it is estimated that more than 90 percent of them take at least one medication during pregnancy and lactation.

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) led a series of Task Force meetings in 2017 and 2018, working with stakeholders from industry, government, and academia. A central theme resonated throughout these meetings: the need to alter widespread assumptions that have significantly limited scientific knowledge of therapies used by pregnant and lactating women. Currently, pregnant and lactating women and their healthcare providers are left with undesirable options: either taking a therapy without high-quality dosing information or not treating a condition. In the case of lactation, women may be choosing to discontinue breastfeeding to take a therapy based on limited information, which then deprives the mother and infant of the benefits of nursing.

More than six million women are pregnant in the United States each year, and it is estimated that more than 90 percent of them take at least one medication during pregnancy and lactation. However, these women often are excluded from clinical research that could help them, even though many therapies are already used by pregnant and lactating women and are necessary for their health. Without research to establish an evidence base, health practitioners need to make decisions with limited information on appropriate dosing. Indeed, a cultural shift is needed; the importance and public health significance of enhancing research efforts to inform medical decision-making for pregnant and lactating women must be recognized.

In September 2018, the Task Force submitted a report with 15 recommendations to HHS Secretary Alex Azar and to members of Congress. Some of the recommendations include removing regulatory and legal barriers preventing research, increasing public awareness of the need for better research in pregnant and lactating women, and providing financial incentives and support to facilitate research and public/private partnerships (2).

Learning about pregnancy medications from the source

NICHD also leads PregSource, a crowdsourcing research project that aims to gather information about pregnancy directly from pregnant women. The project aims to learn about the experiences and health of pregnant women and, eventually, their babies – information that promises to inform future research strategies and improvements in maternal and infant care.  We’ve recently added a medication tracker to PregSource so that participants can share what medications they are taking to help researchers gain a better understanding of the range of therapies used by pregnant women and nursing mothers.

Taken together, initiatives like PRGLAC and PregSource will hopefully start to change the way we approach the use of therapies during pregnancy and lactation. The more we see industry and academia designing studies that include pregnant and lactating women, the better.

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  1. AD, “H.R.34 - 21st Century Cures Act”, (2015). Available at: Accessed October 12, 2018.
  2. NIH, “Task Force on Research Specific to Pregnant and Lactating Women Summary” (2018). Available at: Accessed October 12, 2018.
  3. PregSource, “What is PregSource?”, (2018). Available at: Accessed October 12, 2018
About the Author
Roisin McGuigan

I have an extensive academic background in the life sciences, having studied forensic biology and human medical genetics in my time at Strathclyde and Glasgow Universities. My research, data presentation and bioinformatics skills plus my ‘wet lab’ experience have been a superb grounding for my role as a Deputy Editor at Texere Publishing. The job allows me to utilize my hard-learned academic skills and experience in my current position within an exciting and contemporary publishing company.

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