Every year, nearly all of the 6 million women who get pregnant in the US will take medication while they are pregnant or breastfeeding. But this population often is excluded from clinical research, one of the gaps highlighted in a new report from a task force organized by the National Institute of Child Health and Human Development (NICHD).
Closing that research gap is one of 15 recommendations from the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC). Established by the 21stCentury Cures Act in late 2016, the panel was charged with advising the Secretary of Health and Human Services (HHS) on identifying and addressing gaps in knowledge and research on safe and effective therapies for pregnant and lactating women. The Secretary of HHS has until December 2018 to decide whether action on the PRGLC recommendations is warranted.
PRGLAC representatives came from across the National Institutes of Health as well as the Centers for Disease Control and Prevention, the HHS Office on Women’s Health, the National Vaccine Program Office, the Agency for Healthcare Research and Quality, and the Health Resources and Services Administration. Also on the panel were the Commissioner of the Food and Drug Administration, the Secretaries of the Department of Veterans Affairs and the Department of Defense and representatives from medical societies, nonprofit organizations, and companies that focus on the health of pregnant women, nursing mothers, or children.
“There is limited scientific knowledge about the effectiveness and optimal dosing of drugs commonly prescribed for pregnant and lactating women,” said NICHD Director Diana W. Bianchi, MD, in a press release. “This needs to change. The theme that resonates clearly throughout the task force recommendations is that we need to emphasize the importance of protecting these populations through research instead of from research.”
Among the other key recommendations from the PRGLAC, an outgrowth of information taken from four open meetings and a public comment period, are the need to:
- Include and integrate pregnant women and lactating women in the clinical research agenda
- Expand the workforce of clinicians and research investigators with expertise in obstetric and lactation pharmacology and therapeutics
- Remove regulatory barriers to research in pregnant women
- Optimize registries for pregnancy and lactation.
The PRGLAC called for a universal consent for pregnancy lactation studies and a change to the requirement for both maternal and paternal consent before a pregnant woman can participate in a study that benefits only the fetus. The report also emphasizes the need for distinct, separate prioritization processes for products for pregnant women and lactating women. Regarding research, the panel said that investigators and sponsors should be required to justify excluding pregnant women and lactating women from study designs and develop studies to capture physiologic changes that occur over time in these populations.
The charter of the PRGLAC expires in March 2019. However, given the work that still needs to be done on researching therapeutic products used by pregnant women and lactating women, the panel has asked the HHS Secretary to consider exercising his authority to extend the panel’s charter.