By: Leah Golbert, SWHR Communications Intern
On July 25, 2024, members of the Coalition to Advance Maternal Therapeutics (CAMT) convened to discuss updates on advancements in the inclusion of pregnant and lactating populations in clinical research.
CAMT advocated for several federal appropriations requests for FY2024 and FY2025, which were the focus of updates during the meeting. The FY24 appropriations packages brought two major results for requests that CAMT supported:
- Congress provided $200,000 for the PRGLAC Advisory Committee to continue activities within the 2020 Task Force on Research Specific to Pregnant and Lactating Women (PRGLAC) Implementation Plan; and
- Congress urged the US Food and Drug Administration (FDA) to finalize guidance removing pregnant women as a vulnerable population in research and provide further guidance about ethical issues to be considered when designing clinical trials
In FY2025, CAMT is supporting four appropriations requests that it is hopeful will be included in final spending packages:
- National Institute of Health Priority Research: $2 million to the NIH for prioritization of research on existing medications and therapeutics prescribed to pregnant and lactating women.
- PRGLAC Advisory Committee: $200,000 for the Advisory Committee to continue activities within the Task Force on Research Specific to Pregnant and Lactating Women (PRGLAC)
- Pregnant and Lactating Women in Clinical Trials Public Awareness Campaign: $1 million for public awareness campaign to educate maternal and child health providers, patients and their families on opportunities to enroll pregnant and lactating women into clinical trials and registries
- Women in Clinical Research: Require the FDA to finalize guidance removing pregnant women as a vulnerable population in research and provide further guidance about ethical issues to be considered when designing clinical trials
Related to these FY2025 requests, CAMT submitted outside witness testimony in support of the budgetary requests and sent an organizational letter of support to the House and Senate Appropriations Committees, signed by 16 CAMT member organizations, to emphasize the importance of the inclusion of pregnant and lactating women in clinical research.
CAMT most recently provided feedback to Representatives Diana DeGette (D-CO) and Larry Bucshon (R-IN) in response to their request for information on the 21st Century Cures Act and Cures 2.0, signed by seven CAMT member organizations. CAMT’s response emphasized the need for the removal of regulatory barriers to improve the participation of pregnant women in clinical trials; urges the NIH to accelerate research on the safety and efficacy of medications used during pregnancy and lactation; and emphasized the importance of stakeholder education when it comes to opportunities for pregnant and lactating women to participate in clinical research.
CAMT also was pleased that several Member of Congress were interested in this issue and asked the FDA Commissioner questions for the record in relevant Congressional hearings. Representative Robin Kelly (D-IL) asked a question about pregnant and lactating communities of color and Representative Kathy Castor (D-FL) asked about the timing of release of the final rule on the inclusion of pregnant and lactating women in clinical trials.
Looking to the second half of the year, CAMT is continuing its work on the Advancing Safe Medicines for Moms and Babies Act (HR 1117). The Coalition also reviewed the latest news in research that includes pregnant and lactating populations , which notably included review of National Institute of Child Health and Human Development’s (NICHD) Inaugural Stakeholder Meeting for the Prioritization of Therapeutic Research Needs for Pregnant, Postpartum, and Lactating (PPL) Persons, held on July 10, which aimed to discuss and prioritize areas of need for further research.
Finally, the CAMT meeting included governance updates, announcing that the Society for Women’s Health Research (SWHR) has been elected to Vice Chair of CAMT, represented by Lindsey Miltenberger, SWHR’s Chief Advocacy Officer, and three new rotating Steering Committee members of the Coalition: The Epilepsy Foundation, The Elizabeth Glaser Pediatric AIDS Foundation, and The Preeclampsia Foundation.
To learn more about CAMT membership, click here or view a membership flyer here.
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