COALITION ACTIVITIES AND ANNOUNCEMENTS

CAMT to Host Congressional Briefing on Considerations Surrounding the Inclusion of Pregnant and Lactating Populations in Research

Join the Coalition to Advance Maternal Therapeutics (CAMT) on Tuesday, December 6, from 2:00 - 3:00 p.m. ET for the national webinar and congressional briefing, "Addressing Concerns and Considerations Surrounding the Inclusion of Pregnant and Lactating Populations in Research." During this event, panelists will review ethical considerations surrounding the inclusion of these populations in research, how to ensure the appropriate inclusion of these populations in research, and discuss the current state of this type of inclusion in research, both within the federal government and in the corporate sector.

This event will be the first in a three-part congressional briefing series hosted by the CAMT. Stay tuned for additional information on the next events in the series, which include:

• Pregnant and Lactating Populations in Research: How Leaving These Populations Out Leaves Them Behind (January 2023)
• PRGLAC Then and Now: Where We Are and Where We're Going (February 2023)

Summary Blog from CAMT All-Member Meeting

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Director Diana Bianchi addressed members of the CAMT during last month's all-member meeting.

Read some highlights from her presentation on the CAMT website.

Upcoming Reception Honoring Congresswoman Lucille Roybal-Allard and Congresswoman Jaime Herrera Beutler

On Tuesday, December 6, please join several organizations working across women's health and children's health, for a Reception Honoring Congresswoman Lucille Roybal-Allard and Congresswoman Jaime Herrera Beutler for their commitment to mothers and infants throughout their congressional tenure.

The event will be held Tuesday, December 6, 2022, from 3:00 - 5:00 p.m. ET at the YOTEL (415 New Jersey Avenue NW, Washington, D.C.).

Recent CAMT Legislative Efforts

The CAMT continues to work with Representative Castor (D-FL) on authorizing legislation for the next iteration of the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC), which would include provisions, such as requiring the U.S. Food and Drug Administration (FDA) to update regulations to align to the Revised Common Rule, creating a clearinghouse of clinical trials and registries, and establishing a PRGLAC Coordinating Committee.

The CAMT will send coalition members the draft bill, when available, to review and endorse. If any members of the coalition have suggestions for a Republican cosponsor for the legislation, please email Lindsey Horan.

For questions or to make suggestions related to the CAMT's advocacy efforts, please email Rebecca Abbott. 

Recent FDA Webinar: Engaging Providers to Address Knowledge Gaps on Medication Use in Pregnancy and Lactation

Last month, the FDA Office of Women's Health collaborated with the FDA Center for Drug Evaluation Research, Division of Pediatrics and Maternal Health, to host a continuing education webinar on "Engaging Providers to Address Knowledge Gaps on Medication Use in Pregnancy and Lactation."

The webinar provided an overview of FDA's work in this area and information on how providers can become involved in advancing pregnancy and lactation research. The full webinar recording and additional details can be found here.

FDA OWH Team Publishes Article on Medication Use During Pregnancy

The FDA Office of Women's Health science and research staff published an article, "Behaviors Related to Medication Safety and Use During Pregnancy," in the Journal of Women's Health. This study investigated medication usage, including reasons for changes in use during pregnancy.

Read the article here.

Biden Administration Outlines Plan to Get Addiction-Fighting Medicine to Pregnant Women

In October 2022, the White House Office of National Drug Control Policy (ONDCP) announced the release of the report Substance Use Disorder in Pregnancy: Improving Outcomes for Families. The report outlines how overdose-related deaths in pregnant and postpartum women can be prevented with evidence-based treatment for opioid use disorder, describes systemic and cultural barriers that make accessing care difficult, and outlines key actions the Biden-Harris Administration will take to connect pregnant women with substance use disorder care.

As noted in the press release, "Improving maternal health outcomes and expanding access to evidence-based treatment for all, including pregnant women, are both key priorities for the Biden-Harris Administration, as laid out in President Biden's National Drug Control Strategy and the White House Blueprint for Addressing the Maternal Health Crisis."

Read a press release about the report here and an article from the NYT, which features thoughts from policy analysts on the action plan, here.

NICHDevelopments Spotlight: Longitudinal Maternal & Child Health Information for Research Project

In the latest NICHDevelopments newsletter, NICHD spotlighted the Longitudinal Maternal & Child Health Information for Research Project. This ongoing project, which is expected to be complete in March 2023, aims to strengthen the maternal and infant health data evidence base needed to examine the effects of medical conditions and/or interventions on pregnant, postpartum, and lactating people and their infants. In the future, the implementation guide will expand upon its framework to a range of use cases, including risks for children related to maternal exposure to medications taken during pregnancy.

Learn more about the project here.

MotherToBaby Fact Sheets Now Available on NLM Outlets

The public can now find MotherToBaby fact sheets on the new LactRx app, PubMed, Bookshelf, and other National Library of Medicine (NLM) information outlets. The addition of MotherToBaby fact sheets to NLM increases the visibility of registries and studies for exposures in pregnancy and lactation to professionals and the public utilizing the variety of NLM products. When studies and registries exist, they will be noted on MotherToBaby fact sheets for exposures addressed in those fact sheets. The studies and registries are not limited to studies conducted by MotherToBaby but include registries by other organizations, including universities, hospitals, pharmaceutical companies, and others.

March of Dimes 2022 Report Card Released

March of Dimes released the 2022 Report Card, finding the U.S. preterm birth rate increased to 10.5 percent in 2021, a 4 percent increase in the last year--the worst rate March of Dimes has ever reported. A multitude of factors are fueling the maternal and infant health crisis, including structural racism, poor maternal health, and socioeconomic status. This year, the United States overall scored a preterm birth grade of D+. Take a look at the report to see how states were graded.

Call for Organizational Updates! If you would like to share your organization's latest efforts related to advancing the safety and efficacy of prescription drugs, therapeutics, and vaccines used during pregnancy and breastfeeding in a future newsletter, please email Lindsey Horan.

In the News

Pregnant and Taking Antidepressants? Don't Worry About Neurodevelopment Harm, Study Says

CNN Health | October 4, 2022

"Expectant mothers taking many common antidepressants need no longer worry the medication may harm their child's future behavioral or cognitive neurodevelopment, according to a new study of over 145,000 women and their children across the United States followed for up to 14 years."

Here's How to Approach Flu and Covid Boosters During Pregnancy

Gavi | November 14, 2022

"COVID-19 and flu vaccinations are safe in all trimesters during pregnancy, medical experts say. Bivalent boosters can also be given during pregnancy."

Is Tylenol Safe During Pregnancy? Expert Raises Alarm About Possible Link to Autism, ADHD.

USA Today | November 9, 2022

"Roberta Ness is on a mission to warn pregnant people to use less acetaminophen. Most researchers think the science isn't yet conclusive, but Ness doesn't want to wait."

Selena Gomez Shared Her Fears About Pregnancy and Bipolar Disorder; 4 Moms Offer Their Stories

Today | November 17, 2022

"After Selena Gomez shared how she fears treatment for her bipolar disorder will inhibit her ability to carry a pregnancy to term, moms are sharing their own personal experience with bipolar disorder, pregnancy, and parenthood."

What have you read recently related to the inclusion of pregnant and lactating populations in research?

Past and Upcoming Events

• NIH Pathways to Prevention Workshop: Identifying Risks and Interventions to Optimize Postpartum Health | NIH Office of Disease Prevention, ORWH, NICHD; NHLBI, NIMHD | November 29, 11:00 a.m. - 5:30 p.m. ET

The Coalition to Advance Maternal Therapeutics is administered by the Society for Women's Health Research. For more information about the coalition and its activities, please visit our website, safemeds4moms.org, or contact SWHR Chief Advocacy Officer Lindsey Horan or CAMT Steering Committee Chair Rebecca Abbott.