COALITION ACTIVITIES AND ANNOUNCEMENTS

Senator Murray to be Senate Champion for Advancing Safe Medications for Moms and Babies Act of 2023

Senator Patty Murray (WA) has agreed to once again help lead the Senate effort to pass the Advancing Safe Medications for Moms and Babies Act of 2023 to build upon the important work of the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC). She joins House champions, Representatives Kathy Castor (FL-14), Brian Fitzpatrick (PA-01), and Lauren Underwood (IL-14), on driving efforts to better our understanding of the effect of medications on pregnant and lactating women and their infants.

The CAMT is now actively seeking a Republican member to co-lead the legislation in the Senate. If you have connections in the Senate, or if there is a member you think would be a champion for this work, please contact Lindsey Horan.

CAMT Welcomes Newest Member, HealthyWomen

The Coalition is pleased to welcome HealthyWomen as the newest member of the CAMT. HealthyWomen is dedicated to educating women in the middle -- ages 35-64 -- so they can make informed health decisions, advocate for themselves, and prioritize their health and wellness.

Learn more about HealthyWomen and the organization's work at healthywomen.org.

Want to Engage on the Advancing Safe Medications for Moms and Babies Act?

Does your organization have a Hill Day coming up? Are you planning to meet with any policymakers about maternal health? Let us know! The CAMT is creating materials related to the Advancing Safe Medications for Moms and Babies Act of 2023 that you can use in your outreach.

Email Lindsey Horan if you would like to engage on this legislation.

FDA Takes Additional Steps to Advance Decentralized Clinical Trials

On May 2, the U.S. Food and Drug Administration announced that it is taking steps to support decentralized clinical trials (DCT) for drugs, biologics, and devices, where some or all the trial-related activities occur at locations other than traditional clinical trial sites.  

The FDA released new draft guidance, which will allow some or all trial related activities to take place at the trial participants’ homes or other convenient locations to reduce barriers to participation. Increasing utilization of DCTs is intended to help increase diversity in clinical trials and is anticipated to facilitate the development of drugs in areas of medical need. 

According to a Fierce Biotech article, the new guidance will help patients participate in trials with less burden. Companies seeking to produce DCTs are advised to monitor for data variability and precision, as information comes in from patients’ homes or local facilities.  

The ability to reduce the burden of clinical trial participation on diverse populations provides an opportunity for pregnant and lactating women to more easily participate. While we continue to wait for the FDA to finalize its rule regarding the removal of “pregnant women” as a vulnerable population, DCTs will give researchers more opportunities to include traditionally hard to reach populations in clinical trials. 

CAMT plans to continue tracking this development and identifying opportunities to advocate for inclusion of pregnant and lactating women in guidance for DCTs.  

Read the full FDA press release.  

HHS Releases a Solicitation of Nominations for Organizations to Serve as Non-Voting Representatives to ACWS Subcommittee on Maternal Mental Health

On April 21, the U.S. Department of Health and Human Services (HHS) released a solicitation for applications for the Advisory Committee on Women's Services (ACWS) Subcommittee on Maternal Mental Health. The Subcommittee will consist of five non-voting liaison representatives. Representatives will focus in particular on "maternal mental health issues (including substance use), including prevention, screening, diagnosis, treatment, equity, and community-based interventions."

The date for organizations to nominate a representative for the ACWS is May 31, 2023.

Read the full announcement in the Federal Register.

HealthyWomen Hosting Conversation about Women's Representation in Clinical Trials

On June 1 at 1:00 p.m. ET, HealthyWomen will host the congressional briefing, "Women in Clinical Trials: The Challenge of Research During the Reproductive Years." During the event, panelists will explore the current challenges of including women of reproductive age in clinical trials and how industry, health care providers, federal agencies, and Congress are tackling the program. As part of the event, panelists will provide recommendations for improving trial opportunities for pregnant and lactating women and the importance for maternal health.

LactRx by MotherToBaby is a free app providing current information on the use of medications, vaccines, diagnostic agents, and drugs of misuse during breastfeeding. The LactRx app provides easy access to the LactMed database, a resource from the National Library of Medicine (NLM) that is updated monthly.

Download the LactRx App for iPhone or Android.

MotherToBaby Pregnancy Studies, in partnership with the American Academy of Allergy, Asthma, and Immunology (AAAAI), has received a $10 million grant from HHS Biomedical Advanced Research and Development Authority (BARDA) and the National Institutes of Health (NIH) to continue its national study of COVID-19 vaccines in pregnancy.

The groups are continuing to recruit pregnant volunteers for these studies, which include:

• Those who are currently pregnant and have received an mRNA vaccine (Moderna or Pfizer) anytime from 30 days prior to the first day of the last menstrual period to 30 weeks gestation in order to study immune system response to the mRNA vaccine and protection over time. Previous COVID infection status will also be assessed. (This study requires a blood sample during pregnancy, and antibody tests for the participant and her baby after delivery.)
• Those who have not received and are not planning to receive a COVID-19 vaccine during pregnancy may qualify to volunteer in our comparison group! If they enroll, they will not be asked to receive a COVID-19 vaccine.

Find more information here.

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.

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

Pregnant Women Diagnosed with Cancer get Limited Emotional Support due to Insufficient Research

American Heart Association News | April 19, 2023

"Women who experience depression during pregnancy are more likely than those who don't to be diagnosed with cardiovascular disease within two years of giving birth, new research suggests."

NIH Recognizes Various Tools for Improving Maternal Health Outcomes

mHealth Intelligence | April 6, 2023

"Earlier this month, the National Institutes of Health (NIH) released a list of winners that were selected to advance in a prize competition to improve maternal outcomes known as Rapid Acceleration of Diagnostics Technology (RADx Tech) for Maternal Health Challenge."

Pregnant Women Diagnosed with Cancer Get Limited Emotional Support due to Insufficient Research 

University of Surrey| March 22, 2023  

"Support for pregnant women diagnosed with cancer is limited due to insufficient research into the specific emotional needs associated with a diagnosis at this time, according to a new report from the University of Surrey."

COVID Worsened a Health Crisis Among Pregnant Women

New York Times | March 16, 2023

"The National Center for Health Statistics reported on Thursday that 1,205 pregnant women died in 2021, representing a 40 percent increase in maternal deaths compared with 2020, when there were 861 deaths, and a 60 percent increase compared with 2019, when there were 754."

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

ICYMI: Check out CAMT's Three-Part Congressional Briefing Series

The CAMT concluded its three-part congressional briefing and national webinar series earlier this year to highlight topics related to the inclusion of pregnant and lactating populations in research. The series was intended to raise awareness among policymakers and the public about this research and educate attendees about how the inclusion of these populations in trials improves outcomes for both mother and baby.

The series included the following events:

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.