COALITION ACTIVITIES AND ANNOUNCEMENTS

CAMT Works to Secure Wins in House and Senate FY24 Appropriations Bills

The Coalition to Advance Maternal Therapeutics (CAMT) continues to educate members of Congress about the importance of including pregnant and lactating women in clinical trials.

As a result of those efforts, the coalition saw wins in both House and Senate fiscal year 2024 appropriations bills:

• The Senate Agriculture Appropriations Subcommittee included report language to take steps to harmonize U.S. Food and Drug Administration (FDA) regulations with the Federal Policy for the Protection of Human Subjects (the Common Rule) – specifically, to remove pregnant women as a vulnerable research population.
• The House Labor, Health, and Human Services (Labor-HHS) Appropriations Subcommittee included $200,000 within its bill to support the Advisory Committee charged with monitoring and reporting on the implementation of the recommendations from the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC), Recommendation #15 from the PRGLAC report.  

The Coalition will continue working to secure both requests in final fiscal year 2024 appropriations legislation while also working to advance the Coalition’s recently finalized fiscal year 2025 requests. Find the Coalition’s FY25 requests here. 

Fall 2023 All-Member Meeting Shared Federal and Legislative Updates

The CAMT held an all-member meeting on October 23, 2023 to discuss federal updates and coalition efforts in the 118th Congress.

Topics discussed included current coalition initiatives, the federal budget and appropriations process, and industry partnerships. Highlights included insights on the appropriations process from Becca Flikier, legislative director in the Office of Representative Lois Frankel (D-FL) and a presentation from Marie Teil, Global Head of the Women and Childbearing Age Program at UCB, who discussed UCB's initiatives to support pregnant and lactating populations, including the Women and Childbearing Age Program and the BRIDGE Initiative.

CAMT's 2023 achievements, which included securing funding for the Advisory Committee overseeing the implementation of PRGLAC recommendations, were shared, along with the coalition's policy priorities for the coming months, including new appropriations requests and bolstered legislative initiatives. The meeting concluded with discussions among members on their various projects aimed at improving health outcomes for pregnant and lactating individuals.

Read more about the meeting here.

CAMT Welcomes Newest Corporate Member: Organon

The Coalition is pleased to welcome the newest member of the CAMT Corporate Advisory Committee:

• Organon is a global health care company with a portfolio of therapies and products in women's health, biosimilars, and established brands across a wide array of conditions and diseases. Learn more at organon.com.

Call for CAMT Steering Committee Members!

The CAMT is seeking three member organizations to serve in rotating seats on its Steering Committee. Steering Committee members are elected to serve a two-year term, with the option to renew for a second term at the discretion of the permanent members of the Steering Committee. Nominations are open to organizations in the CAMT.

The CAMT believes having diverse perspectives, expertise, and experiences represented on the Committee will allow us to better understand the needs related to the inclusion of pregnant and lactating populations in research.

Representatives to the Steering Committee must be senior-level individuals who can speak on behalf of their organizations during Committee deliberations and should have a background in policy and government relations to ensure that the member can help guide CAMT policy efforts. If a representative from an elected organization vacates his/her/their position, the organization will be asked to appoint another senior representative for the remainder of that term.

Elected Steering Committee members should be prepared to make the following time commitments:

• Attend monthly Steering Committee calls (one hour/month)
• Review collateral materials, as necessary (roughly one hour/month)
• Attend Hill meetings and engage with partners, as able (time varies)

To nominate your organization for a seat on the CAMT Steering Committee, please email a short statement of interest about why your organization would like to serve on the Committee and how it can help advance and represent the coalition's mission to lindsey@swhr.org by COB February 15. The Steering Committee will review applications in February.

Seeking Advocates from Washington State!

CAMT is seeking advocates from Washington to do Hill meetings about the importance of including pregnant and lactating populations in research and discuss your work in this space.

If you would like to participate in these meetings, please contact Lindsey Miltenberger at lindsey@swhr.org.

Save the Date: CAMT Member Webinar

Save the date! The CAMT will host an all-member webinar on Friday, February 23 at 11:00 a.m. ET. During this webinar, the CAMT will provide updates on fiscal year 2024 and fiscal year 2025 spending legislation and will share potential opportunities for advocacy among the coalition members.

Additional information will be forthcoming.

Coalition Organized Four Recent Letters to Federal Government

The CAMT organized four letters to federal policymakers in the last quarter of 2023 that sought to advance policy priorities of the coalition.

In October, the Coalition worked with members of Congress to send a Dear Colleague letter to the FDA urging the agency to harmonize its regulations and guidance with the Common Rule. The Coalition then sent a letter from members of the Coalition making the same request. Then, in November, members of the CAMT sent a letter to leaders of the House and Senate Labor-HHS Appropriations Subcommittees requesting $200,000 in final fiscal year 2024 legislation for the Advisory Committee to implement the PRGLAC recommendations. Finally, in December, the Coalition sent a letter to the new White House Initiative on Women’s Health Research urging them to include pregnant and lactating women in their work.

Read the letters here.  

First Meeting the PRGLAC Working Group

In 2023, NICHD formed the PRGLAC Implementation Working Group of Council to monitor and report on the implementation of recommendations from the PRGLAC report.

The Working Group, of which several CAMT members are a part, met for its first meeting on November 17, 2023. The next meeting will take place January 19, 2024. The Working Group is expected to provide updates and findings from its work to the National Advisory Child Health and Human Development (NACHHD) Council in June 2024. Learn more here.

ACOG to Host Webinar "Access in Crisis: Maternal Health Awareness Day" Webinar

In observance of Maternal Health Awareness Day, the American College of Obstetrics and Gynecologists (ACOG) on January 23 at 2:00 p.m. ET will host a live webinar featuring people who are navigating and working to mitigate the maternal and reproductive health care access crisis in the United States. In this one-hour webinar, ACOG members on the front lines of the crisis will shed light on ongoing challenges facing those seeking and providing maternal and reproductive health care. Experts in maternal health will speak on navigating workforce shortages, the realities of practicing in rural or historically underserved areas, and work being done to understand the maternal mortality crisis and advocate for solutions.

Society for Birth Defects Research and Prevention to Host 64th Annual Meeting

The 64th Annual Meeting of the Society for Birth Defects Research and Prevention will take place June 22–26, 2024, in the vibrant city of Pittsburgh, Pennsylvania. The theme for this year’s meeting is “Addressing Disparities in Birth Defects Research and Prevention.” Abstracts are due February 15. Trainees whose abstracts are accepted are eligible for travel awards. Full program details, abstract submission instructions, travel award application, and more may be found on the meeting website. 

BRIDGE Commission Prepares for Launch of Recommendations Report on Closing the Information Gap for Empowerment of Women with Chronic Diseases Before, During, and After Pregnancy

Today, a significant lack of data and research is leaving women living with chronic diseases without the information they need to make vital health decisions during their reproductive health journeys. BRIDGE is a global, multidisciplinary group of physicians, researchers, patients, and women’s health advocates working to empower women with chronic diseases to make informed decisions about their treatment before, during, and after pregnancy. Our goal is to advance practical and action-oriented solutions to overcome information gaps that affect women’s health during pregnancy and breastfeeding — the first of which will be detailed in a report due early this year.

Learn more about BRIDGE, its members, and updates by visiting the BRIDGE website, and join the conversation on social media by following #BRIDGE4WomensHealth.

The multidisciplinary BRIDGE Commission and the development of its website has been supported by UCB.

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 Miltenberger.

NICHQ Hosts “The Equity Exchange: Innovation in Reproductive and Child Health” 

The Equity Exchange is a new, equity-focused virtual event series, hosted by the National Institute for Children’s Health Quality's (NICHQ) Department of Health Equity and Innovation. This series provides a unique space to exchange innovative ideas, learn and discuss emerging theories, and share resources and tools on topics related to equity in maternal and child health. Expect something different than your standard webinar, with more ways to interact and engage on our new platform.  

Register for their first event on January 23, 2024, 3:00-4:00 PM ET here. 

FDA Hosts Public Workshop on Advancing the Use of Complex Innovative Designs in Clinical Trials: From Pilot to Practice  

On March 5th, 2024, the FDA is conducting a public workshop to discuss aspects of complex adaptive, Bayesian, and other novel clinical trial designs. 

The purpose of this public workshop is to facilitate discussion on the use of external data sources, Bayesian statistical methods, and simulations in complex innovative trial designs as well as trial implementation. 

The meeting will consist of two sessions. The first session will focus on case studies illustrating various aspects of complex innovative designs and implementation. The second session will consist of panel discussions motivated by the case studies. Registration will be available starting January 15, 2024. Learn more here. 

Upcoming Event to Focus on Innovative Approaches to Clinical Trials

Duke-Margolis, under a cooperative agreement with FDA, is hosting the hybrid workshop "Enhancing Adoption of Innovative Clinical Trial Approaches" on March 19-20, 2024. Key topics of discussion for the event will include the current state of trial innovation; regulatory, patient-centric, and organizational challenges; and collaboration across industry to tackle innovation challenges.

The hybrid location of the event is the Kellogg Conference Hotel, 800 Florida Ave NE, Washington, D.C. 20002.

In the News

Acetaminophen Use During Pregnancy Linked with Language Delays, University of Illinois Study Finds

CBS News Chicago | January 3, 2024 

A recent study from the University of Illinois at Urbana-Champaign suggests a link between acetaminophen use during pregnancy and language delays in children. The research focused on language development in 2- to 3-year-old children, revealing that those whose mothers took acetaminophen, particularly in the third trimester, exhibited smaller vocabularies and shorter sentence lengths. The study is ongoing, investigating other aspects of neurodevelopment and planning to follow the children to assess if the language delays persist over time. 

Prenatal Folic Acid Supplements Tied to Lower Risk of Kawasaki Disease

MedPage Today | January 1, 2024

A Japanese observational study found that folic acid supplementation throughout pregnancy was associated with a lower risk of early-onset Kawasaki disease in offspring. Children of women with above-average serum folic acid levels during the second and third trimesters had a significantly lower incidence of Kawasaki disease by 12 months of age. The study, using data from the Japan Environment and Children's Study, suggested a potential link between folic acid and reduced risk of Kawasaki disease, speculating that additional folic acid supplements during pregnancy, along with a proper diet, might contribute to this risk reduction. 

Social Determinants in Prenatal Antidepressant Use and Continuation: Systematic Review and Meta-Analysis

Acta Psychiatrica Scandinavica | December 25, 2023 

Prenatal depression is common and linked to postpartum depression (PPD), impacting both mothers and children. Antidepressant use during pregnancy is rising, but social determinants may influence access to treatment. A review of 23 studies explored the impact of social determinants on prenatal antidepressant use. Lower education levels were significantly associated with lower rates of antidepressant continuation during pregnancy. However, the meta-analysis found no association with race, relationship status, or income. High study heterogeneity limited definitive conclusions, but the study suggests education level may influence prenatal antidepressant continuation. 

A Medical Breakthrough for Postpartum Depression Within a Deeply Flawed System

MedPage Today| December 15, 2023 

The FDA approval of zuranolone for PPD is hailed as a scientific triumph, offering fast-acting relief. However, concerns arise about accessibility due to the drug's high cost ($15,900 for a 14-day course). Existing barriers to perinatal mental health care, socioeconomic and racial disparities, and insurance challenges may limit access for those who need it most. The broader issue of insufficient access to maternal mental health care prevails, with life-threatening consequences for severe PPD cases. 

Jill Biden Will Lead New Initiative to Boost Federal Government Research Into Women's Health

AP News | November 13, 2023

The Biden administration has launched the White House Initiative on Women’s Health Research, aiming to address the underrepresentation of women in health research. Led by First Lady Jill Biden and the White House Gender Policy Council, the initiative seeks to close research gaps and improve women's health outcomes. The effort recognizes the impact of research disparities on women's health and plans to involve various government departments, agencies, and external collaborations. The initiative will focus on issues such as heart attacks, menopause, and other areas where additional investments could be transformative. 

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

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 Miltenberger or CAMT Steering Committee Chair Rebecca Abbott.