COALITION ACTIVITIES AND ANNOUNCEMENTS

Representatives Castor, Underwood, and Fitzpatrick Reintroduce Advancing Safe Medications for Moms and Babies Act of 2023

On Thursday, February 23, Representatives Kathy Castor (FL-14), Brian Underwood (PA-01), and Lauren Underwood (IL-14) reintroduced H.R. 1117, the Advancing Safe Medications for Moms and Babies Act of 2023. The legislation, building upon the Advancing Safe Medications for Moms and Babies Act of 2016, aims to better our understanding of the effect of medications on pregnant and lactating women and their infants.

The press release on the legislation's introduction can be found here, and a section-by-section summary of the bill can be found here.

Endorsements of the legislation are being accepted on a rolling basis. To endorse the bill, please contact Representative Castor's Legislative Director Nora Blalock.

CAMT's Work to Advance Inclusion of Pregnant and Lactating Women in Last Stretch of 117th Congress

Building off its work from earlier in the year, the CAMT worked to advance the inclusion of pregnant and lactating women in research at the federal level during the last stretch of the 117th Congress.

There were several provisions supporting the inclusion of pregnant and lactating people in clinical trials in the end-of-year fiscal year 2023 spending package, and members of the CAMT assisted policymakers with the introduction of the Advancing Safe Medications for Moms and Babies Act of 2022 in December. These successes are highlighted in a blog post that can be viewed on the CAMT's website, safemeds4moms.org.

CAMT Wraps Up Successful Three-Part Congressional Briefing Series

The CAMT recently concluded its three-part congressional briefing and national webinar series 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:

FDA to Require Diversity Plan for Clinical Trials

The omnibus spending package enacted in December will require diversity action plans for the clinical trials used by the U.S. Food and Drug Administration (FDA). The new law comes on the heels of a 2022 National Academies of Sciences, Engineering, and Medicine (NASEM) report, which found that certain populations, including pregnant people, remain severely underrepresented in clinical trials.

According to a Nature article on the new FDA diversity requirement, "To comply with the diversity requirement, researchers and pharmaceutical firms will need to list their demographic goals for the participant pool, their rationale for the goals, and an explanation of how they intend to meet them."

Prior to enactment of the new requirement, FDA will have to finalize its draft guidance and provide the public opportunity to comment, which according to the Nature piece, "could take more than two years." Another point of concern cited in the article is whether FDA will enforce the policy. Currently, the text allows FDA to waive the need for a diversity-action plan in certain circumstances or if a disease or condition is not considered prevalent among the general population.

Read more about the new FDA requirement in Nature and Bloomberg Law.

HHS Hosts Maternal Health Stakeholder Briefing

On Friday, February 17, the U.S. Department of Health and Human Services (HHS) hosted a briefing on maternal health priorities and activities for 2023. During the briefing, HHS Secretary Xavier Becerra and other agency leaders discussed maternal health provisions from the fiscal year 2023 omnibus spending legislation as well as other Departmental efforts to advance equity in maternal health outcomes.

Among the items discussed during the briefing were the Health Resources and Services Administration (HRSA) Maternal Health Innovation Awards, Postpartum Medicaid Expansion, and the EREASE Maternal Mortality Program at the U.S. Centers for Disease Control and Prevention (CDC).

Read a recap of the briefing from 2020 Mom.

The 63rd Annual Meeting of the Society for Birth Defects Research and Prevention will take place June 24–28, 2023, in Charleston, South Carolina. The theme for this year’s meeting is “Improving Pregnancy Outcomes through Collaborative Research.”

The program will feature the keynote lecture, "Protecting Mothers and Babies Through Research: A Time for Change," by Christina Bucci-Rechtweg, MD, Head, Pediatric & Maternal Health Policy, Global Drug Development Regulatory Affairs, Novartis Pharmaceuticals Corporation, and the Robert L. Brent Lecture, "Teratology Research in the Shadow of the Dobbs Decision," by Anne Drapkin Lyerly, MD, MA, Professor of Social Medicine, University of North Carolina at Chapel Hill.

Scientific sessions will include The HEALthy Brain and Child Development Study, A Lifecourse Perspective on the Epidemiology of Congenital Heart Disease, COVID-19 and Pregnancy: An Update and Planning for the Future, and more.

Late-Breaking Abstracts may be submitted in April and May. Full details are on the meeting website. 

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

Strategies Needed to Increase Female Representation in CVD Clinical Trials

Healio | February 28, 2023

"There is also a bias due to the mindset 'do no harm.' As a result, we tend to not recruit women of childbearing age, in case they are pregnant and could potentially be exposed to a harmful intervention. We need to include women of all ages so we can see how therapies affect women."

COVID-19 Vaccine Not Associated with Adverse Outcomes in Pregnant Women

AJMC | February 27, 2023

"COVID-19 vaccination during pregnancy was not associated with any adverse outcomes, according to a review published in Frontiers in Public Health. Neonatal and maternal outcomes were not associated with any potential adverse effects from the COVID-19 vaccine."

HIV Prevention Drug: Experts Call for Inclusion of Pregnant, Breastfeeding Mothers

Premium Times | February 5, 2023

"The inclusion of pregnant and breastfeeding women in the HIV clinical trial intervention for Pre-exposure Prophylaxis (PrEP) is important to curb the spread of the virus... This was the consensus during a five-day virtual training organized by the New HIV Vaccine and Microbicide Advocacy Society (NHVMAS) to educate journalists on developments in the fight against HIV and how to address existing gaps."

Diversity in Clinical Trials at FDA Gets a Boost from New Law

Bloomberg Law | January 19, 2023

"The 2023 omnibus spending bill enacted last month (Public Law 117-328) requires diversity action plans for the clinical trials used by the Food and Drug Administration to decide whether drugs are safe and effective."

'Clinical Trials': Key Words Missing from New CMS Health Equity Framework

Natural Products Insider | January 19, 2023

"In 2022, CMS published a “Framework for Health Equity 2022-2032” with the goal of addressing health disparities and achieving health equity while driving action toward the nation’s top health priorities...While the publication of this framework is an important step for public health, two very important words are missing from the 40-page strategic plan: clinical trials."

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.