COALITION ACTIVITIES AND ANNOUNCEMENTS | |
CAMT Announces New Steering Committee Members! | |
Thank you to all the organizations that expressed interest in joining the Coalition to Advance Maternal Therapeutics (CAMT) Steering Committee.
We are pleased to welcome the following organizations to the CAMT Steering Committee in a rotating member capacity:
Please join us in welcoming our newest Steering Committee members! We look forward to working more closely with these organizations as we collectively seek to improve the inclusion of pregnant and lactating populations in research!
| CAMT Welcomes New Member to Coalition | |
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The Coalition is pleased to welcome its newest member:
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Lupus Foundation of America has a mission to improve the quality of life for all people affected by lupus through programs of research, education, support, and advocacy. It is focused on achieving the following disease-specific outcomes: reduce time to diagnosis, ensure people with lupus have an arsenal of safe and effective treatments, and expand direct services and increase access to treatment and care.
Welcome, LFA!
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CAMT Request Included in Final FY24 Appropriations Legislation | |
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In March, Congress passed two fiscal year (FY) 2024 appropriations packages, or "minibuses," which were later signed into law by President Biden.
The CAMT was pleased to see that, within the final Labor, Health and Human Services, Education, and Related Agencies (Labor-HHS) explanatory statement and bill for fiscal year 2024, $200,000 was provided to support the Pregnant and Lactating Women Advisory Committee at the National Institute of Child Health and Human Development (NICHD). This Committee is tasked with monitoring and reporting on the implementation of recommendations from the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC).
CAMT commends Congress and PRGLAC champion Representative Lois Frankel (D-FL) for their ongoing dedication to implementing the PRGLAC recommendations.
| NASEM Committee Members Present New Report to CAMT | |
Seeking Advocates from Washington State! | |
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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.
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Reps. Castor and Salazar Lead Off-Committee Letter in Support of CAMT's FY25 Appropriations Requests | |
The Coalition worked in collaboration with members of Congress to organize an off-committee letter to the House Appropriations Committee urging the prioritization of maternal and infant health through the inclusion of pregnant and lactating populations in research and clinical trials. The letter was led by Representatives Kathy Castor (D-FL) and Maria Salazar (R-FL). Twenty-five members of Congress signed on in support of the letter and CAMT’s appropriations requests.
The letter comes during a critical time, as Congress is in full swing with the FY 2025 appropriations process. The House and the Senate have begun budget hearings for FY 2025, which have included hearings with U.S. Department of Health and Human Services (HHS) Secretary Becerra and U.S. Food and Drug Administration (FDA) Commissioner Califf. The deadline for lawmakers to pass FY25 spending legislation is September 30, 2024.
The Coalition looks forward to continuing its work withe the House and Senate Appropriations Committees to advance our requests. View the CAMT’s FY25 requests here.
| FDA Releases Public Comment Request on Pregnancy Exposure Registry Enrollment | |
On April 26, 2024, FDA released a public comment request to determine health care providers' (HCPs) perceived barriers to sufficient patient enrollment in pregnancy exposure registries. The FDA particularly invites comments on:
- Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;
- The accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
- Ways to enhance the quality, utility, and clarity of the information to be collected; and
- Ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
The request for public comment will be open until June 25, 2024. The full announcement can be found in the Federal Register.
| President Biden Releases Executive Order on Women's Health | |
President Biden issued an executive order on Monday, March 18, 2024, aimed at expanding research on women’s health care and strengthening data standards. The executive order includes over 20 new actions and commitments by federal agencies, including a commitment of $200 million in FY 2025 for new, interdisciplinary women's health research at the National Institutes of Health (NIH). This funding is seen as a first step towards a proposed "Fund on Women’s Health" that President Biden called on Congress to support in his 2024 State of the Union address.
The executive order represents a comprehensive set of executive actions aiming to address longstanding gaps in women's health research and innovation. Key areas of focus include integrating women’s health across federal research portfolios, prioritizing investments in research on midlife health issues affecting women, and assessing unmet needs in women’s health research. Carolyn Mazure, PhD, chair of the White House Initiative on Women’s Health Research, emphasized the transformative potential of this effort to improve women’s health nationwide.
Last December, the CAMT Steering Committee sent a letter to Dr. Mazure requesting that the White House prioritize the inclusion of pregnant and lactating populations in clinical trials as part of its recommendations. Read the letter here.
| FDA Establishes Center for Drug Evaluation and Research (CDER) Center for Clinical Trial Innovation (C3TI) | |
FDA last month announced the establishment of the Center for Drug Evaluation and Research (CDER) Center for Clinical Trial Innovation (C3TI). C3TI aims to be a central hub within CDER to support innovative approaches to clinical trials that are designed to improve the quality and efficiency of drug development and regulatory decision making. C3TI will also seek to improve communication and collaboration to promote existing CDER programs and drive future clinical trial innovations.
The new center should facilitate easier access to information on clinical trial innovation, encourage collaborations, identify resources for innovative methods, and target development programs where integrating clinical trial innovations could have a significant impact. The goals include keeping clinical research stakeholders informed about innovations, enhancing trial efficiency and effectiveness, increasing diversity in trial participation, and ultimately accelerating the development of safe and effective new medications. Learn more here.
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Role of WHNPs in the Scholarship of Discovery, Practice, and Teaching | |
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The National Association of Nurse Practitioners in Women’s Health (NPWH) recognizes a critical need for women’s health nurse practitioner (WHNP) scholars in discovery, practice, and teaching to improve women’s and gender-related health care and health outcomes. WHNPs with earned doctoral degrees can make unique contributions to scholarship with their combination of advanced practice nursing knowledge and skills and expertise in women’s and gender-related health.
Scientific research led by WHNP scholars is needed to expand the evidence base to understand the connections among these facets. Translational science led by WHNP scholars is needed to develop, implement, and evaluate strategies based on the evidence to reduce health disparities and improve health care and health outcomes.
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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 Lindsey Miltenberger.
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RESOURCES AND UPCOMING EVENTS | |
Webinar: Closing the Information Gap: Chronic Disease, Pregnancy, and Breastfeeding | |
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On May 21, 2024, at 11:00 a.m. ET, STAT is hosting a webinar focused on closing the information gap on the realities of women taking prescription medicine during pregnancy. Experts from BRIDGE will join STAT Brand Studio to discuss practical solutions to overcome this information gap in women’s health.
Register and learn more here.
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Inaugural Stakeholder Meeting on Therapeutics Research Prioritization for Pregnant, Postpartum, and Lactating People | |
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On July 9-10, 2024, NICHD will host the Inaugural Stakeholder Meeting on Therapeutics Research Prioritization for Pregnant, Postpartum, and Lactating People. This meeting will mark the next phase in the prioritization process for nominations on drug, vaccine, and dietary supplement research needs for pregnant, postpartum, and lactating persons that NICHD received in response to a related Request for Information published in 2023.
The meeting will be held in-person at the NICHD offices in Bethesda, MD, with a virtual option for those who do not wish to travel.
Stay tuned for registration information to come this spring.
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FDA Alerts Health Care Professionals of Pregnancy Problems Associated with Thiopurines
FDA | April 29, 2024
FDA has issued an alert to health care professionals regarding potential pregnancy-related issues associated with thiopurine medications. Thiopurines, which are used to treat certain medical conditions like inflammatory bowel disease and autoimmune disorders, have been linked to adverse pregnancy outcomes including miscarriage, stillbirth, and low birth weight. The FDA recommends that health care providers carefully consider the risks and benefits of thiopurine use in pregnant individuals and those planning pregnancy. They advise counseling patients about these risks and considering alternative treatments when appropriate.
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Acetaminophen Use During Pregnancy and Children's Risk of Autism, ADHD, and Intellectual Disability
National Library of Medicine | April 9, 2024
Studies suggest that acetaminophen use during pregnancy may increase the risk of neurodevelopment disorders in children. However, through this study researchers found that acetaminophen use during pregnancy was not associated with children's risk of autism, ADHD, or intellectual disability. This suggests a need for additional studies to highlight the importance of filling this information gap in women’s health.
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FDA's Clinical Inspections Declined Amid Staffing Challenges
Bloomberg Law| March 25, 2024
FDA has identified a decline in clinical inspections due to staffing challenges. Despite an increase in the number of clinical trials, the FDA's ability to inspect these trials has decreased over the past decade. Factors contributing to this decline include limited resources, staffing shortages, and increased workload. As a result, there are concerns about the FDA's ability to ensure the safety and efficacy of medical products. Therefore, highlighting the importance of addressing staffing challenges to maintain effective oversight of clinical trials.
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Plastic Food Packaging Contains Thousands of Hormone-Mimicking Chemicals: Study
The Hill| March 5, 2024
This article discusses a recent study which found hormone-mimicking chemicals in plastic food packaging, raising concerns about potential health risks. Researchers detected various harmful chemicals in several types of plastic packaging commonly used for food storage and preparation. These harmful chemicals are known to interfere with hormones, suggesting a potential link to health issues such as infertility, obesity, and cancer. The study highlights the need for increased investigation into how even common products affect our health.
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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 Chief Advocacy Officer Lindsey Miltenberger or CAMT Steering Committee Chair Rebecca Abbott. | | | | |
