The Complementary Nature of Federal Science Agencies in Advancing the Nation’s Health

October 04, 2021


As our nation looks to tackle both longstanding and new and emerging challenges, science entities across the federal government play a critical role in improving the health and wellness of the American people. These agencies play unique but complementary roles in maximizing research and development priorities and addressing cross-cutting science issues.

Two of these entities are the National Institutes of Health (NIH) and the Food and Drug Administration (FDA). During SWHR’s September Policy Advisory Council meeting, SWHR hosted FDA’s Deputy Commissioner for Policy, Legislation, and International Affairs Andi Fristedt and Laura Berkson, JD, director of the Office of Legislation, Public Policy, and Ethics at NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), who discussed how the two entities are working to advance the nation’s health with an emphasis on women’s health. The updates demonstrated the complementary nature of FDA and NIH’s portfolios through regulatory and biomedical science, product safety, and more.

At a high level, key places where FDA focuses its efforts are led by FDA’s Office of Women’s Health (OWH). These efforts include advancing the inclusion and representation of women in clinical trials, driving work on sex and gender analysis forward, and furthering cross-cutting and multidisciplinary women’s health initiatives both within FDA and with partners and stakeholders. NICHD, on the other hand, investigates human development, seeks to improve reproductive health, and enhances the lives of children and adolescents through its research portfolios.

Diving into their latest activities and initiatives, one area that is presently top of mind for both FDA and NICHD is the COVID-19 crisis. NICHD has been exploring how COVID-19 has impacted its focus populations of children and pregnant women. Additionally, the Institute is examining population fertility – namely how the pandemic has affected family planning and individuals’ decisions as well as its effect on birth outcomes and the differential impact across population subgroups. Berkson also shared that the Institute is conducting research in spaces that have been widely reported on in the media and on social media that may be contributing to vaccine hesitancy, including the linkage between COVID-19 vaccination and fertility (to date, there has been no evidence of an association between the two) and between COVID-19 vaccination and menstruation (there is anecdotal evidence that women have experienced changes in their menstrual cycle following COVID-19 vaccination).

FDA has also had a workstream focused on COVID-19. Fristedt noted that early on, FDA’s OWH recognized clear gaps in the collective knowledge about COVID-19 in women and has been actively funding work to bridge these gaps, specifically looking at sex differences, long COVID, and pregnancy and lactation, complementing NIH’s research lanes. FDA’s OWH has also been active in releasing outward-facing, education communications, including webinars on vaccinations in women and educational materials for staff and federal partners to increase understanding of the importance of sex and gender differences and their application to regulatory science with respect to COVID-19.

Another corresponding workstream of the two agencies focuses on maternal health. FDA has worked closely with NIH on research specific to pregnant and lactating women, including determining how best to implement the recommendations from the Task Force on Research Specific to Pregnant and Lactating Women (PRGLAC) and funding research to expand knowledge on medication used during pregnancy and breastfeeding. NIH, through programs like the Implementing a Maternal health and PRegnancy Outcomes Vision for Everyone (IMPROVE) initiative and the Decoding Maternal Morbidity Data Challenge, is also working to address maternal morbidity and mortality in the United States. The initiatives, respectively, support research to reduce preventable causes of maternal deaths and improve health for women before, during, and after delivery, and identify new ways of analyzing NICHD’s Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-be (nuMoM2b) data to identify factors that impact maternal morbidity and severe maternal morbidity so clinicians can more quickly and accurately identify and treat pregnancy-related conditions and prevent severe illness or death for a pregnant person.

Beyond NIH and FDA’s work in the spaces outlined above, there are clear implications for women’s health—and on pregnant and lactating populations—in many of their research areas. Fristedt also noted that health equity, for women and particularly women of color, is at the center of everything they do.

For more information about the agencies’ latest activities and initiatives, please visit the FDA website and the NICHD website.

Resources

For questions, please contact SWHR Chief Advocacy Officer Lindsey Horan.

 

As our nation looks to tackle both longstanding and new and emerging challenges, science entities across the federal government play a critical role in improving the health and wellness of the American people. These agencies play unique but complementary roles in maximizing research and development priorities and addressing cross-cutting science issues.

Two of these entities are the National Institutes of Health (NIH) and the Food and Drug Administration (FDA). During SWHR’s September Policy Advisory Council meeting, SWHR hosted FDA’s Deputy Commissioner for Policy, Legislation, and International Affairs Andi Fristedt and Laura Berkson, JD, director of the Office of Legislation, Public Policy, and Ethics at NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), who discussed how the two entities are working to advance the nation’s health with an emphasis on women’s health. The updates demonstrated the complementary nature of FDA and NIH’s portfolios through regulatory and biomedical science, product safety, and more.

At a high level, key places where FDA focuses its efforts are led by FDA’s Office of Women’s Health (OWH). These efforts include advancing the inclusion and representation of women in clinical trials, driving work on sex and gender analysis forward, and furthering cross-cutting and multidisciplinary women’s health initiatives both within FDA and with partners and stakeholders. NICHD, on the other hand, investigates human development, seeks to improve reproductive health, and enhances the lives of children and adolescents through its research portfolios.

Diving into their latest activities and initiatives, one area that is presently top of mind for both FDA and NICHD is the COVID-19 crisis. NICHD has been exploring how COVID-19 has impacted its focus populations of children and pregnant women. Additionally, the Institute is examining population fertility – namely how the pandemic has affected family planning and individuals’ decisions as well as its effect on birth outcomes and the differential impact across population subgroups. Berkson also shared that the Institute is conducting research in spaces that have been widely reported on in the media and on social media that may be contributing to vaccine hesitancy, including the linkage between COVID-19 vaccination and fertility (to date, there has been no evidence of an association between the two) and between COVID-19 vaccination and menstruation (there is anecdotal evidence that women have experienced changes in their menstrual cycle following COVID-19 vaccination).

FDA has also had a workstream focused on COVID-19. Fristedt noted that early on, FDA’s OWH recognized clear gaps in the collective knowledge about COVID-19 in women and has been actively funding work to bridge these gaps, specifically looking at sex differences, long COVID, and pregnancy and lactation, complementing NIH’s research lanes. FDA’s OWH has also been active in releasing outward-facing, education communications, including webinars on vaccinations in women and educational materials for staff and federal partners to increase understanding of the importance of sex and gender differences and their application to regulatory science with respect to COVID-19.

Another corresponding workstream of the two agencies focuses on maternal health. FDA has worked closely with NIH on research specific to pregnant and lactating women, including determining how best to implement the recommendations from the Task Force on Research Specific to Pregnant and Lactating Women (PRGLAC) and funding research to expand knowledge on medication used during pregnancy and breastfeeding. NIH, through programs like the Implementing a Maternal health and PRegnancy Outcomes Vision for Everyone (IMPROVE) initiative and the Decoding Maternal Morbidity Data Challenge, is also working to address maternal morbidity and mortality in the United States. The initiatives, respectively, support research to reduce preventable causes of maternal deaths and improve health for women before, during, and after delivery, and identify new ways of analyzing NICHD’s Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-be (nuMoM2b) data to identify factors that impact maternal morbidity and severe maternal morbidity so clinicians can more quickly and accurately identify and treat pregnancy-related conditions and prevent severe illness or death for a pregnant person.

Beyond NIH and FDA’s work in the spaces outlined above, there are clear implications for women’s health—and on pregnant and lactating populations—in many of their research areas. Fristedt also noted that health equity, for women and particularly women of color, is at the center of everything they do.

For more information about the agencies’ latest activities and initiatives, please visit the FDA website and the NICHD website.

Resources

For questions, please contact SWHR Chief Advocacy Officer Lindsey Horan.