COALITION ACTIVITIES AND ANNOUNCEMENTS

CAMT Secures Critical Wins in the House and Senate FY24 Appropriations Bills

The Coalition to Advance Maternal Therapeutics (CAMT) has been working diligently to educate members of the 118th Congress on the importance of including pregnant and lactating women in clinical trials. Our efforts have proved successful.  

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. This language is a result of CAMT’s continued effort to educate members of Congress on the critical need for harmonization, as well as partnership with longtime partners, such as Sen. Patty Murray.  

The House Labor, Health and Human Services, Education, and Related Agencies Appropriations (Labor-HHS) Subcommittee included $200,000 within its bill to support an 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), which will be housed at the National Institute of Child Health and Human Development (NICHD). The Advisory Committee meets Recommendation #15 of the PRGLAC report. CAMT applauds Congresswoman Lois Frankel (D-FL) for her continued advocacy for this vital funding.  

The Coalition will continue working to secure both requests in the final fiscal year 2024 appropriations bill.  

Call for Signers: Coalition Sign-on Letter to FDA Urging Harmonization

The CAMT is planning to send a letter to FDA leadership, urging that the agency work expeditiously to harmonize FDA Human Subjects Regulations with the Common Rule. This letter is critical, and the timeline for harmonization from 21st Century Cures is four years overdue.  

The deadline to sign your organization on to the letter has been extended to Friday, September 22. You can sign your organization on here. To view a copy of the draft letter, click here. For any questions, please email Lindsey Horan or Becky Abbott.  

CAMT Welcomes Newest Members: Preeclampsia Foundation and Wake Up Narcolepsy

The Coalition is pleased to welcome the two newest members of the CAMT:

• The purpose of the Preeclampsia Foundation is to improve the outcomes of hypertensive disorders of pregnancy by educating, supporting, and engaging the community, improving health care practices, and finding a cure. Learn more about the Foundation at preeclampsia.org.
• Wake Up Narcolepsy is dedicated to driving narcolepsy awareness, education, and research towards improved treatments and a cure. Learn more at wakeupnarcolepsy.org.

Update From CAMT July 20 Meeting and a Call for Patient Advocates

On July 20, the CAMT met to discuss current federal updates and coalition efforts in the 118th Congress.

CAMT’s efforts have centered around funding for a PRGLAC Advisory Committee, ensuring the harmonization of FDA guidelines to align with the Common Rule (i.e., removing pregnant and lactating populations as a vulnerable population) and improving consensus standards for pregnant and lactating population registries. Additionally, efforts have focused on advancing H.R. 1117, the Advancing Safe Medications for Moms and Babies Act of 2023 and the introduction of companion legislation in the Senate.  

Additionally, CAMT is working to increase grassroots and grasstops advocacy across various organizations. There is no one better to hear from than a constituent. We are looking for organizations who will reach out to their representatives and senators about the importance of including pregnant and lactating women in clinical trials.

We are also seeking patient advocates who would be willing to share their personal stories about deciding whether to take medications during pregnancy or breastfeeding and would be willing to share them on the CAMT website and/or with lawmakers on Capitol Hill.  

If your organization would be willing to assist in outreach or you know someone who might be willing to share their story, please contact Lindsey or Adriianna Lagorio.

CAMT Publishes New Resources

Have you visited the CAMT website recently? The Coalition has added several new resources to assist members in their advocacy to increase representation of pregnant and lactating populations in research:

• Q&A: The Role of Clinical Trials in Keeping Mothers and Babies Safe
• Advancing Safe Medications for Moms and Babies Act Flyer
• Advancing Safe Medications for Moms and Babies Act Section-by-Section Summary

These materials are intended to increase bipartisan co-sponsorship of the Advancing Safe Medications for Moms and Babies Act and address common questions we have received from staffers. Find more resources on the Advocacy Resource Page on the Coalition’s website.  

Do you have ideas about other collateral that would benefit you in your advocacy? Contact Lindsey Horan.

Upcoming All-Member Meeting: Monday, October 23

We hope you will join us for the upcoming CAMT all-member meeting. The meeting will be held on Monday, October 23 from 1:00 - 2:30 p.m. ET in the 11th Floor Conference Room at 1025 Connecticut Ave NW in Washington, D.C.

RSVP to Lindsey Horan.

Bipartisan Lawmakers Circulating Letter to Encourage FDA Harmonization

Members of the U.S. House of Representatives are leading a letter to FDA Commissioner Califf urging the FDA to harmonize regulations and guidance governing the inclusion of pregnant women in clinical research with the Common Rule. Reps. Kathy Castor (D-FL), Lori Chavez-DeRemer (R-OR), Lauren Underwood (D-IL), and Maria Elvira Salazar (R-FL) are leading the letter.

NIH Releases RFI on the Prioritization of Drug, Vaccine, and Dietary Supplement Research Needs for Pregnant, Postpartum, and Lactating Persons  

On May 23, NICHD released a Request for Information (RFI) calling for stakeholders to nominate drug, vaccine, and dietary supplement research needs to be considered in the development of a Priority List of Drug, Vaccine, and Dietary Supplement Research Needs for Pregnant, Postpartum, and Lactating Persons. 

The RFI will be open until September 29, 2023. The full announcement can be found in the Federal Register.  

NASEM Releases Proceedings of Workshop-in-Brief

In March 2023, as part of a consensus study about how institutions and organizations make risk-benefit decisions regarding the inclusion and exclusion of pregnant and lactating persons in research, and the role of real and perceived liability considerations, health equity, risk management, and trial insurance in those decisions, the National Academies' Committee on Developing a Framework to Address Legal, Ethical, Regulatory, and Policy Issues for Research Specific to Pregnant and Lactating Persons hosted a workshop.

The Proceedings of a Workshop - in Brief summarizes the discussions held during the workshop.

March of Dimes Report Released on Maternity Care Deserts  

On August 1, March of Dimes published a new report, “Where You Live Matters: Maternity Care Deserts and the Crisis of Access and Equity,” which summarizes the ongoing maternity health crisis in the U.S. by highlighting the fact that more than 5.6 million women live in counties with limited, or no access, to maternity care services. 

The report also details: 

• The loss of obstetric units in hospitals was responsible for decreased maternity care access in 369 counties since the 2018 report, nearly 1-in-10 counties across the United States. 
• 70 additional counties have been classified as maternity care deserts due to a loss of obstetric providers and obstetric units in hospitals, since the initial report in 2018. 
• More than 32 million reproductive-age women are vulnerable to poor health outcomes due to a lack of access to reproductive healthcare services, like family planning clinics and skilled birth attendants. 
• States with the highest rates of maternity care deserts include North Dakota, South Dakota, Alaska, Oklahoma and Nebraska, states with more rural populations. 

Human Teratogens Course Happening This November

The Human Teratogens Course will take place November 13-15, 2023. This live, virtual continuing education course is co-hosted by USF Health, the Society for Birth Defects Research and Prevention, and the Organization of Teratology Information Specialists. Course faculty, teratology and toxicology experts, will present lectures that cover basic principles of teratology, embryology, and epidemiology as well as detailed information regarding maternal conditions and environmental exposures which may pose teratogenic effect in pregnancy and lactation. The course provides up-to-date information on common exposures and pressing topics, such as COVID-19 and vaccines, that providers are likely to encounter in their practice. The target audience for this course includes obstetricians, maternal fetal medicine specialists, teratogen information specialists, genetic counselors, pharmacists, and allied health professionals.

HealthyWomen Engages on Lack of Diversity in Clinical Trials

HealthyWomen recognizes that if we don’t represent everyone in clinical trials — including women and people of color — we don’t have complete data about how certain conditions affect everyone or what treatments work — and at what dose — for everyone. These knowledge gaps are especially stark for pregnant and lactating women.

That's why HealthyWomen convened a congressional policy briefing, “Women in Clinical Trials: The Challenge of Research During the Reproductive Years,” to educate Congress on the current status of studying women during their reproductive years and why this should be essential to public health. Advocacy organizations like HealthyWomen have long known that clinical trials and subsequent research analysis focus on white men, leaving women and people of color not only woefully underrepresented but uninformed about their health as women. 

HealthyWomen also partnered with CancerCare to look at What You Need to Know About Clinical Trials and to demystify clinical trials.

A Message from Wake Up Narcolepsy

Wake Up Narcolepsy (WUN) recently announced its involvement as a member organization of the CAMT. WUN shared the following statement:

"WUN finds that the mission of CAMT aligns with our values and believes that this involvement will benefit individuals living with Narcolepsy that are currently pregnant, lactating or will be in the future. Specifically, we are excited to involve our Pregnancy & Parenting with Narcolepsy Support Group, which meets online every week on Tuesdays at 8pm ET, as they have firsthand experience making decisions about medication use during this important phase of life." 

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.

FDA Hosts Public Workshop Optimizing the Use of Postapproval Pregnancy Safety Studies

This workshop, convened by the Duke Margolis Center for Health Policy, which was held September 18-19 in Washington, D.C. included discussions of designs of postapproval pregnancy safety studies for drug and biological products. The workshop also included discussion of considerations for further development of a framework that describes how data from different types of postapproval pregnancy safety studies may be used when it has been determined that this data should be collected. 

For more information and details on the event visit the Federal Register Announcement here. 

FDA Hosts Workshop to Enhance Clinical Study Diversity 

The FDA will host a public workshop to solicit input from stakeholders in efforts to increase diversity in clinical trials.  

The public workshop will focus on increasing participation of historically underrepresented populations in clinical studies and encouraging clinical study participation that reflects the prevalence or incidence of the disease or condition among demographic subgroups, where appropriate. Additionally, one of the topics of discussion includes “the establishment of inclusion and exclusion criteria for certain subgroups, such as pregnant and lactating women and individuals with disabilities, including intellectual or developmental disabilities or mental illness.” 

The workshop will take place virtually on November 29 from 10 a.m. to 2 p.m. and November 30 from 10 a.m. to 2 p.m. ET. A public comment period will be established to receive comments related to the topics addressed during the public workshop. Either electronic or written comments on this public workshop must be submitted by January 29, 2024.  

For more information on the workshop please visit the announcement in the Federal Register. To register, visit the Duke website here. 

In the News

What is Texas Doing About the Higher Rates of Maternal Mortality Among Black Women? 

CBS News | June 15, 2023 

"Texas’s DHHS is using the Hear Her Maternal Health Campaign to prevent maternal deaths and improve maternal health by sharing resources and health risks. The campaign engages the Black community by providing initiatives and integrated behavioral healthcare from preconception to postpartum. By helping individuals receive access to screening and care, this knowledge can be translated into action and prevention to improve Black maternal health."

Blood Test Can Help Doctors Predict Severe Preeclampsia Earlier and More Accurately

UChicago News | June 28, 2023

"The new test detects two proteins in the blood that predict preeclampsia with better accuracy than the method of measuring blood pressure and proteins in urine. The test can be used in tandem with other methods between 23 and 35 weeks of pregnancy to stratify who is high risk and low risk for severe preeclampsia. Doctors hope that this can lessen the disparity seen in Black women who are 60% more likely to develop preeclampsia than white women."

FDA Approves First Oral Treatment for Postpartum Depression 

FDA | August 4, 2023 

"The U.S. Food and Drug Administration approved Zurzuvae (zuranolone) as the first oral medication to treat postpartum depression (PDD). After giving birth, adults experiencing symptoms of postpartum depression – sadness, a loss of interest, and possibly suicidal ideation – can take the daily recommended dose of 50mg once with dinner for 14 days straight."

US FDA Approves Pfizer’s Maternal RSV Vaccine to Protect Infants 

Reuters| August 21, 2023 

"The U.S. Food and Drug Administration approved Pfizer’s respiratory syncytial virus (RSV) vaccine for women between 32 and 36 weeks of pregnancy. Mothers who receive the vaccine will protect their newborn from severe consequences of RSV from birth until six months of age. The approval was based on a study of 7,000 pregnant people that showed the vaccine was 82% effective in preventing severe RSV infections in infants."

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 Horan or CAMT Steering Committee Chair Rebecca Abbott.