COALITION ACTIVITIES AND ANNOUNCEMENTS

SWHR Assumes Administration Responsibilities of the CAMT

Earlier this month, the Society for Women's Health Research (SWHR) announced that it will be overseeing the administration of the Coalition to Advance Maternal Therapeutics (CAMT). 

SWHR, as an initial member of the CAMT and one of the four permanent members of the coalition's Steering Committee, is well-suited to take on these responsibilities, which include overseeing funding, administrative, and logistics support, in coordination with other Steering Committee members. The change in administration, along with a new, formalized structure, will equip the CAMT to identify and address areas of need and quickly respond to evolving policy opportunities. The Society for Maternal-Fetal Medicine (SMFM) will continue to serve in the role of the Chair of the CAMT. 

Read the full announcement online here. For questions, please contact SWHR Chief Advocacy Officer Lindsey Horan or CAMT Steering Committee Chair Rebecca Abbott.

CAMT Launches New Website

The CAMT has a new home! In order to increase the visibility of the coalition and its work, the CAMT now has a dedicated website, safemeds4moms.org. 

The new website will house CAMT correspondence with policymakers, CAMT's current membership and membership opportunities, and news updates related to the inclusion of pregnant and lactating populations in research. 

Recap of Recent CAMT Efforts

Over the past few months, the CAMT has had meetings with federal officials and worked to advance pregnant and lactating population research in policy. This work has included the following: 

• Working 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 Food and Drug Administration (FDA) to update regulations to apply with 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.
• Coordinating with the House to strengthen language related to pregnant and lactating people in user fee reauthorization.
• Drafting a letter to appropriators calling for the inclusion of the House provisions for fiscal year 2023 in the final spending bill. The provisions include encouraging the National Institutes of Health (NIH) to continue implementation of PRGLAC recommendations and providing $200,000 for the creation of a Pregnant Women and Lactating Women Advisory Committee.

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

SAVE THE DATE! The CAMT all-member annual meeting will be held on Thursday, October 20, 2022 at 11:00 a.m. ET. Please be on the lookout for additional information!

Coming Soon: RADx Tech Maternal Health Challenge  

The NIH will announce the Rapid Acceleration of Diagnostics Technology (RADx^® Tech) for Maternal Health Challenge, a competition offering up to $8 million in cash prizes to accelerate development of technologies to improve maternal health outcomes for those who live in areas lacking access to maternity care. The challenge will prioritize home-based or point-of-care diagnostic devices, wearables, and other remote sensing technologies to extend care and improve health outcomes during the postpartum period.

The challenge will launch on September 1, 2022. Submissions for the multi-phase competition are due November 1, 2022, and final winners are expected to be announced in March 2024. Visit the NIH website for more information.

NICHD Celebrates 60-Year Anniversary

The Eunice Kennedy Shriver National Institute for Child Health and Human Development (NICHD) will celebrate its 60th anniversary on Monday, October 17, 2022 with a virtual symposium. Since 1962, NICHD has been a global leader in scientific endeavors to understand human development, improve reproductive health, enhance the lives of children and adolescents, and optimize abilities for all.

This one-day event is part of a year-long anniversary effort to recognize NICHD's accomplishments and envision the future of its research portfolio. The symposium will be videocast live and recorded. For the agenda and registration details, visit the symposium website.

Recording Available: FDA Workshop on Real-World Data to Study Medication Use in Pregnancy and Lactation

During National Women’s Health Week this past May, the FDA Office of Women’s Health (OWH) hosted an informative virtual public workshop on "Leveraging Real-World Data to Study Medication Use in Pregnancy and Lactation." Developed in collaboration with the Johns Hopkins Center of Excellence in Regulatory Science and Innovation, the workshop focused on the potential role of real-world data to help address gaps in our knowledge on medication use in pregnancy and lactation. Participants also discussed opportunities and challenges of collecting real-world data, and current regulatory perspectives on the collection and potential use of real-world data and real-world evidence.

The workshop recording can be viewed here.

OWH also developed an educational webinar in collaboration with CDER’s Division of Pediatrics and Maternal Health. This webinar examined how our current prescription drug labeling system can be used to inform prescribing medications in pregnancy and lactation. The "Pregnancy and Lactation Medication Information for the Healthcare Provider" webinar can be viewed here.

You can stay abreast of OWH public meetings, workshops, and webinars by visiting the dedicated webpage here: www.fda.gov/OWHmeetings.

Call for Comments: NIH-Wide Strategic Plan for Research on the Health of Women

The NIH Office of Research on Women's Health (ORWH) is seeking comments from its stakeholders to assist with the development of the 2024-2029 NIH-Wide Strategic Plan for Research on the Health of Women. Specifically, the Office is seeking feedback on research opportunities that should be modified, emerging research needs and opportunities, and themes that should be common to all future strategic goals and objectives.

Please see the recently published Perspectives on Advancing NIH Research to Inform and Improve the Health of Women, a report based on the “Advancing NIH Research on the Health of Women: A 2021 Conference” and the previous strategic plan for motivation. All responses must be submitted here by September 29, 2022.

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

"God, No, Not Another Case." COVID-Related Stillbirths Didn't Have to Happen

ProPublica | August 4, 2022

"A lack of testing data and government guidance led many to avoid the COVID-19 vaccine during pregnancy, unwittingly increasing their chances of a stillbirth."

How Misinformation About COVID Vaccines and Pregnancy Took Root Early On and Why It Won't Go Away

ProPublica | August 4, 2022

"The decision to delay or avoid vaccination, often made out of an abundance of caution and love for the baby growing inside of them, had dire consequences: Unvaccinated women who contracted COVID-19 while pregnant were at a higher risk of [complications]."

The Problem with Being Too Cautious in Vaccine Trials

The Atlantic | August 6, 2022

"In vaccine research, the usual presumption has been that people who are pregnant or under 18 are uniquely vulnerable to being harmed by medical research. But in many cases, that means that they end up being studied last—and are systematically excluded from the benefits of innovation during epidemics."

Should Pregnant Women be Included in Clinical Trials? 

News-Medical.net | August 8, 2022

"It is imperative to develop a framework or guidelines with common criteria that justify the inclusion or exclusion of pregnant women in clinical trials. The convention participants emphasized that the ethical framework must be focused on recruiting participants based on protecting pregnant women through their inclusion in research."

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

Past and Upcoming Events

• Diverse Voices Virtual Talk: COVID-19 and Women | ORWH | Recording
• Diverse Voices Virtual Talk: Trauma and Addiction Impacts on Pregnant/Postpartum Women | ORWH | September 29, 2:00 - 3:00 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.