Advancing Maternal and Infant Health: Centralized Data Collection for Postmarketing Evaluation Congressional Briefing and Interagency Discussion

The American Academy of Allergy, Asthma & Immunology (AAAAI), as the facilitator of the Vaccines and Medications in Pregnancy Surveillance System (VAMPSS), invites you to attend a congressional briefing and discussion on feasibility and possible next steps to systematically obtain necessary data through new infrastructures/collaborations to address evidence gaps on safety in the treatment of pregnant and lactating women.

Guest panel participants, name and organization:

• Moderator: Lynda Kabbash, MD, AAAAI Advocacy committee
• Alison Cernich, PhD, Deputy Director, National Institute of Child Health and Human Development (NICHD)
• Keele Wurst, PhD MS, GSK
• Christina Chambers, PhD MPH, Mother To Baby Pregnancy Studies
• Kathryn Schubert, MPP CAE, Society for Women’s’ Health Research – hear from SWHR at the event!

Background: In 2017, the US Department of Health and Human Services, through the National Institutes of Health, Child Health and Development Institute (NICHD), launched the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) to evaluate and recommend solutions to the lack of human safety data for drugs in pregnancy and lactation. Part of the 21st Century Cures Act, the PRGLAC Task Force confirmed the lack of necessary information and recommended solutions, and has subsequently initiated an ongoing evaluation process for implementation of those recommendations.

In November 2019 a workshop was convened by the National Heart, Lung, and Blood Institute, the National Institutes of Health (NIH) Office of Research on Women’s Health, and the Food and Drug Administration (FDA) Office of Women’s Health, titled “The Safety of Asthma Medications during Pregnancy and Lactation: Research Priorities and Methodology.” This workshop engaged stakeholders to mobilize efforts to address gaps in knowledge on asthma medication safety in pregnancy and lactation.

The 2024 National Academies of Sciences, Engineering, and Medicine (NASEM) report Advancing Clinical Research with Pregnant and Lactating Populations Overcoming Real and Perceived Liability Risks highlights the need for a consolidated safety data infrastructure to develop and maintain a centralized national registry for collecting and evaluating postmarketing data from pregnant and lactating women.

RSVP: The AAAAI invites you to attend this briefing and conversation. Please email vampss@aaaai.org for more information or to RSVP.