COALITION ACTIVITIES AND ANNOUNCEMENTS | |
CAMT Builds on Past Appropriations Successes in Fiscal Year 2025 | |
The Coalition to Advance Maternal Therapeutics (CAMT) continues to work to advance the inclusion of pregnant and lactating women in clinical trials via the Congressional appropriations process. In addition to the coalition’s historical requests of $200,000 for the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) and report language encouraging the Food and Drug Administration (FDA) to harmonize its regulations with the Common Rule by removing pregnant women as a vulnerable research population, CAMT is advocating for two additional requests in FY25. These requests are based on the Advancing Safe Medications for Moms and Babies Act (ASMMBA), which is legislation the coalition supports.
First, the Coalition supported report language directing the National Institutes of Health (NIH) to give preference to research applications that will address gaps in clinical research on the medications’ effects on pregnant and lactating women with $2,000,000 in funding for this research. Second, the Coalition supported allocating $1,000,000 for the creation of a public awareness campaign to educate maternal and child health providers, patients, and their families on the availability of clinical trials and research for pregnant and lactating women.
While the environment in Congress surrounding appropriations has been tough this year - particularly among calls to substantially decrease funding to federal health institutions - CAMT is proud to have secured several of our requests in recently released drafts of both the House and Senate appropriations bills. House drafts have included $200,000 for the PRGLAC Advisory Committee, report language urging the prioritization of research on medications’ effects on pregnant and lactating women, and report language urging the FDA to harmonize with the Common Rule. Senate drafts similarly included $200,000 for the PRGLAC Advisory Committee and report language urging the FDA to harmonize with the Common Rule.
While these draft bills demonstrate great progress for CAMT’s first year advancing four separate requests, the Coalition will continue our work with Congressional champions to advance these requests as negotiations continue. Be on the lookout for a letter of support to the Appropriations Conference Committee to be released shortly! Learn more about the Coalition’s FY25 requests here.
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CAMT Organizational Letter of Support for FY25 Requests | |
The Coalition to Advance Maternal Therapeutics sent an organizational sign-on letter of support to House and Senate appropriations leadership urging the prioritization of maternal and infant health through the inclusion of pregnant and lactating populations in clinical trials for fiscal year 2025. The coalition's letter is a call to action for lawmakers to allocate necessary funding and resources to support a more inclusive approach to pregnant and lactating women in medical research, reflecting a broader commitment to advancing maternal and infant health. Read the full letter here. | |
CAMT Submits Response Letter on Next-Generation 21st Century Cures Act | |
The Coalition to Advance Maternal Therapeutics Steering Committee recently responded to a request for information from Representatives Diana DeGette (D-CO-01) and Larry Bucshon (R-IN-08) on a law building on the 2016 21st Century Cures Act. Among many elements, the 21st Century Cures Act worked to streamline development and delivery for drugs and medical devices and established the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC). The Steering Committee used this opportunity to advocate for the inclusion of policies to accelerate the inclusion of pregnant and lactating populations in clinical trials. Find the full response here. | |
House Energy & Commerce Committee Hearing on Regulation at the Food and Drug Administration | On Wednesday, May 22nd, the House Energy and Commerce Committee Subcommittee on Health held a hearing titled “Examining FDA Regulations of Drugs, Biologics, and Devices.” During the hearing, Representatives Castor (D-FL-14) and Kelly (D-IL-02) asked questions regarding including pregnant and lactating women in clinical trials. The director of the Center for Drug Evaluation and Research (CDER), Dr. Patrizia Cavazzoni, MD explained that they are working with developers to increase research while navigating litigation concerns. Watch the hearing here. | Department of Health and Human Services (HHS) Backs Food and Drug Administration (FDA) Reorganization Proposal | The Department of Health and Human Services (HHS) has officially endorsed the FDA's proposed reorganization of its food program and inspection program. This endorsement allows the FDA to move forward with finalizing the overhaul later this year. The reorganization initiative follows an independent review of the FDA's food program, which identified a lack of clear leadership structures and a tumultuous internal culture. These issues have been criticized for hampering the agency's ability to effectively do its job, including responding to the recent infant formula crisis. Learn more here. | Biomedical Advanced Research and Development Authority (BARDA) Partners with Walgreens for First Pharmacy-Based Decentralized Clinical Trial | In a significant effort to enhance access to clinical trials, the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response, is allocating $25 million in Project NextGen funding to Walgreens. This initiative marks BARDA’s first collaboration with a major retail pharmacy to conduct a decentralized clinical trial. The innovative approach aims to increase participation from individuals of diverse backgrounds, including varying ages and ethnicities. Using the funding, Walgreens will conduct a Phase IV clinical study on immunity using an FDA-authorized or licensed COVID-19 vaccine. Learn more here. | Health Resources and Services Administration (HRSA) Announces $15 Million Investment in Rural Maternal Health Programs | On June 3rd, the U.S. Department of Health and Human Services’ Health Resources and Services Administration (HRSA) revealed a $15 million investment over four years in maternal health programs through the Rural Maternity and Obstetrics Management Strategies (Rural MOMS) Program. This initiative aims to improve maternal health in rural communities and launch a new program to enhance maternal care and reduce disparities in the Delta region. The Rural MOMS Program awarded recent recipients nearly $4 million to each organization over four years to pilot innovative approaches for supporting, enhancing, and expanding access to maternal and obstetric care in rural areas. The program emphasizes a network model to coordinate care across rural hospitals, medical centers, community health centers, and rural health clinics. Learn more here. |
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Call for Papers: Vaccines during Pregnancy and Lactation | |
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The Society for Birth Defects Research (SBDR) has released a call for papers for their upcoming special issue addressing research gaps, community engagement, and policy issues related to vaccine use during pregnancy and lactation.
As SBDR notes, the recent recommendations for use of the COVID-19 and RSV vaccines during pregnancy and the impending release of several other vaccines has raised issues about the number of vaccines recommended during pregnancy and the push for inclusion of pregnant and lactating populations in clinical trials.
These advances in obstetric care occur at a time when public perception of the safety, effectiveness, and need for vaccines is declining. Decreasing vaccination rates and widespread misinformation and fear about potential reproductive effects of the COVID-19 vaccine reveal breaches in public confidence about the benefits of vaccination. Submissions related to these issues or other topics related to vaccination during pregnancy and lactation are due by November 30, 2024.
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Maternal Mental Health Leadership Alliance (MMHLA) Launches New Perinatal Mental Health Training Database for Health Care Professionals | |
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The Maternal Mental Health Leadership Alliance (MMHLA) recently announced the launch of its new Perinatal Mental Health Training Database. The database offers over 160 trainings on various topics, allowing users to filter by topic, profession, duration, continuing education credits, and more. This centralized, searchable platform addresses the immediate need for accessible perinatal mental health training. MMHLA aims to integrate perinatal mental health education into existing curricula and training programs for all professionals supporting pregnant and postpartum individuals to enhance their knowledge or perinatal mental health conditions.
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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 Madelyn Adams.
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RESOURCES AND UPCOMING EVENTS | |
27th Annual NPWH Women's Healthcare Conference | |
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Earn up to 24 Continuing Education contact hours at the 27th Annual National Association of Nurse Practitioners in Women’s Health (NPWH) Women's Healthcare Conference. With over 25 sessions led by health care experts, the event will cover critical topics such as menopause, trauma-informed care, cardiovascular health, contraceptive management, and more to support your practice.
The conference will take place September 25-28, 2024, in Chicago.
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Opportunity to Join the Teva Migraine Pregnancy Registry | | |
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Naloxone Use During Pregnancy—Data from 26 US Jurisdictions, 2019–2020
Journal of Addiction Medicine |
June 24, 2024
A study titled "Naloxone Use During Pregnancy—Data from 26 US Jurisdictions, 2019–2020," published in the Journal of Addiction Medicine, examined the prevalence of naloxone use among pregnant individuals in the U.S. who recently gave birth.
Analyzing data from the Pregnancy Risk Assessment Monitoring System (2019-2020), the study identified high-risk individuals based on the use of illicit amphetamines, heroin, cocaine, or receipt of medication for opioid use disorder (MOUD). Less than 1% of the overall study population reported using naloxone during pregnancy. Among high-risk groups, naloxone use prevalence was 5.0% for illicit amphetamine users, 15.2% for heroin users, 17.6% for cocaine users, and 14.5% for those on MOUD.
No significant differences in naloxone use were found by age, race/ethnicity, education, metropolitan status, or insurance among high-risk individuals. The study highlights the importance of enhancing access to naloxone, overdose prevention education, and treatment for substance use disorders to improve maternal and fetal health outcomes.
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U.S. Infant Deaths Rises for First Time in Decades
Health Day News | July 25, 2024
For the first time in two decades, the infant mortality rate in the United States has risen, according to new data from the Centers for Disease Control (CDC). In 2022, over 20,500 infants died before reaching one year old, equating to 5.6 deaths per 1,000 live births, a 3% increase from 2021. Amanda Jean Stevenson, a demographer, emphasized the significance of this rise, noting the long-term trend of decreasing rates since 1995.
The leading causes remained congenital malformations, preterm birth complications, sudden infant death syndrome (SIDS), unintentional injuries, and maternal complications. Notably, deaths from maternal complications increased by 9%. The report highlighted that infant health is closely linked to maternal health, which has been challenged by high maternal mortality rates and COVID-19 impacts. Black and Native American infants continued to experience the highest mortality rates.
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Study Finds Long-acting Injectable Cabotegravir for HIV Prevention is Safe in Pregnancy
National Institutes of Health |
July 23 2024
Long-acting injectable cabotegravir (CAB-LA) has been found to be safe and well-tolerated as HIV pre-exposure prophylaxis (PrEP) before and during pregnancy in a global study including over 300 pregnancies among cisgender women.
Providing evidence-based HIV prevention options for pregnant women is particularly important given their increased risk of HIV acquisition during pregnancy and postpartum. CAB-LA, administered bi-monthly via injection, is a highly effective HIV prevention method, but its safety during pregnancy was previously unclear. These findings support the safety of CAB-LA before and during pregnancy, addressing a critical need for effective PrEP options for cisgender women.
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Fluoride Exposure During Pregnancy Linked to Behavior Problems in Kids
Neuroscience News| May 20, 2024
A new study from the University of Florida finds that higher fluoride levels in pregnant women are associated with increased odds of their children experiencing neurobehavioral problems at age three. These problems include anxiety, difficulty regulating emotions, and physical complaints like stomachaches and headaches.
This research is the first of its kind in the U.S., and highlights that there is no known benefit of fluoride for developing fetuses despite widespread consumption. This study contributes to the ongoing debate about the health impacts of fluoride, which has been added to U.S. community water supplies since the 1940s to reduce dental cavities. Researchers have urged policymakers to create specific recommendations for fluoride consumption during pregnancy based on these findings.
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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 Public Policy & Advocacy Manager Madelyn Adams or CAMT Steering Committee Chair Rebecca Abbott. | | | | |
