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  1. From a Global Perspective

The Global Need for Pregnant and Breastfeeding Women in Clinical Research — the Health of the Child Begins with the Health of the Mother

FROM A GLOBAL PERSPECTIVE

By Lt. Cmdr. Shannon Thor, Pharm.D

March 29, 2023

From a Global Perspective

 

With Women’s History Month 2023 coming to a close, the FDA’s Office of Global Policy and Strategy (OGPS) is celebrating the ongoing efforts of Europe Office Deputy Director Lt. Cmdr. Shannon Thor, Pharm.D, and others to promote inclusion of pregnant and breastfeeding women in clinical research — an important area of women’s health. Recognizing that “the health of the child begins with the health of the mother,” Lt. Cmdr. Thor, working with both her regulatory counterparts and colleagues within the FDA, is continuing to make inroads in this area of research, helping expand the knowledge base for scientists and regulators in Europe and the United States while improving expertise on the rational use of medicines and vaccines for pregnant and breastfeeding women.

As a pharmacist, I am passionate about increasing access to evidence-based information on medicines and vaccines, which empowers patients in making heath decisions. However, research on use of medicines and vaccines during pregnancy and breastfeeding has faced barriers and controversy for decades, leading to a persistent lack of data to support clinical decision-making in pregnant and breastfeeding women. This creates the risk of inadequate or inappropriate treatment — or even lack of treatment — any of which can result in significant health consequences for the mother or child. Many factors contribute to this, including the temporary nature of pregnancy. Still, when considering the majority of medicines and vaccines, women and their health care providers are placed in an impossible position —having to make health care decisions in an information vacuum. 

Despite these challenges, however, a guiding principle that “the health of the child begins with the health of the mother” is widely accepted. Following this ethic, clinicians, scientists, and regulators in the United States and Europe — recognizing the importance of international collaboration — are diligently seeking new strategies to generate evidence-based information that women and their health care providers can use to make treatment decisions with confidence.

Shannon Thor

 

The FDA’s Europe Office, headquartered in Brussels, has long been engaged in global efforts to address the scarcity of information available at the preclinical, clinical, and postmarket stages. The Europe Office helped lead a two-day regulators workshop in January 2020 on the topic, partnering with colleagues from the FDA’s medical product centers, the European Medicines Agency (EMA), and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA). Subsequently, workshop leaders authored a report detailing strategies and new approaches for a shared path forward.

In July 2021, the FDA Europe Office brought together experts from the FDA’s Office of Women’s Heath, Center for Drug Evaluation and Research, and Center for Biologics Evaluation and Research to publish an FDA Voices article: “Global Regulators Envision Paradigm Shift Toward Inclusion of Pregnant and Breastfeeding Women in Clinical Research for Medicines and Vaccines.” Our article described the FDA’s national and international activities supporting health research that benefits pregnant and breastfeeding women.

Most notably, in recent years the FDA Europe Office led the FDA, EMA, and MHRA in establishing a Pregnancy and Lactation Cluster, a group of regulators intent on fostering a consistent approach across regulatory jurisdictions to assure evidence-based safe and effective use of medicines and vaccines during pregnancy and breastfeeding. The cluster is committed to:

  • Engaging in discussions such as interpretation of data, strategies for data collection and clinical trials, labeling, and risk management.
  • Sharing best practices that address ethical, scientific, and regulatory barriers to promote clinical trial inclusion and participation of pregnant and breastfeeding individuals and individuals who may become pregnant.
  • Encouraging early, aligned, and consistent engagement with sponsors during product development and after approval. 
  • Fostering sound nonclinical and clinical investigations in these populations, including novel clinical trial designs, clinical pharmacology studies, and statistical methods. 
  • Establishing best practices for identifying products where early exploration of use in pregnancy or breastfeeding is essential according to unmet needs and priority products used by pregnant and breastfeeding individuals.
  • Identifying opportunities to challenge product developers and researchers to partner globally to develop robust modern methods in electronic data collection and analysis to jump-start research in this area.

Recently, FDA Cluster leaders, along with colleagues in OGPS, published research that compared FDA and EMA pregnancy and lactation labeling language. This research helped characterize regional differences in labeling, further highlighted the need for more human data to inform prescribing decisions within these populations, and suggested an opportunity exists for labeling alignment across regions.

U.S. and European regulators share the desire for greater inclusion of pregnant and breastfeeding women in clinical research. The FDA Europe Office, alongside partners across the agency, will continue to show global leadership and drive momentum in this important area of women’s health, engaging stakeholders including women, health care professionals, regulators, industry, and public health experts.

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