This public workshop enabled stakeholders to examine the current state of evidence generation for drug products used by pregnant and lactating persons and discuss barriers and opportunities for including these populations in clinical trials. The workshop was hosted by the National Academies’ Forum on Drug Discovery, Development, and Translation, and provided a foundation for a related consensus study on this topic, which was requested by Congress in the Consolidated Appropriations Act, 2022.
A recording of the workshop is available to view below. A workshop proceedings, which provides a factual recounting of the workshop discussions can be found here and highlights from the workshop can be found here.
For additional information on the workshop, please visit our project page.
Background
Approximately 4 million persons in the United States give birth annually. Over 60 percent of them are prescribed a medication during their pregnancy for either a chronic condition or one arising from the pregnancy itself. Yet, due to historical events, such as the widely publicized birth defects resulting from exposure to thalidomide during pregnancy, evaluating the safety and effectiveness of drugs in pregnant and lactating persons has been viewed as risky and has not been prioritized [1]. As a result, pregnant and lactating persons are often taking drugs with limited data to inform safety, dosing, and efficacy. This population, as well as their fetuses and breast-feeding infants, is thus often subjected to treatments with uncharacterized risks and harms due to their exclusion from clinical trials [2]. To address these issues, the Task Force on Research Specific to Pregnant Women and Lactating Women suggested that the National Academies of Sciences, Engineering, and Medicine convene a group of experts to discuss conducting research with pregnant and lactating persons [3].
A planning committee of the National Academies of Sciences, Engineering, and Medicine, will organize a public workshop to examine the current state of evidence generation for drug products used by pregnant and lactating persons and discuss barriers and opportunities for including these populations in clinical trials.
The public workshop will feature invited presentations and discussions to:
- Highlight knowledge gaps on drug product use during pregnancy and lactation with consideration for the clinical, ethical, and public health impacts on patient health;
- Discuss the laws and regulations governing drug research and development for these populations;
- Consider the liability risks to private and public stakeholders for conducting drug research and development for medical conditions experienced by pregnant and lactating persons, liability risks associated with the use of drug products in these populations, and other barriers to inclusion of pregnant and lactating persons in clinical trials;
- Discuss practical short- and long-term opportunities and/or actions to improve evidence generation on the risks and benefits of therapeutic interventions for pregnant and lactating persons and increase their inclusion in clinical trials.
The planning committee will organize the workshop, develop the agenda, select and invite speakers and discussants, and moderate or identify moderators for the discussions. A proceeding of the presentations and discussions at the workshop will be prepared by a designated rapporteur in accordance with institutional guidelines.
Planning Committee
Ruth Faden (co-chair), Johns Hopkins University
Shirley Sylvester (co-chair), Johnson & Johnson
Ebony Boyce Carter, Washington University School of Medicine in St. Louis
Nahida Chakhtoura, Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH
William Cooper, Vanderbilt University
Darcie Everett, Center for Biologics Evaluation and Research, FDA
Steven Kern, Bill and Melinda Gates Foundation
Leslie Meltzer Henry, University of Maryland
Leyla Sahin, Center for Drug Evaluation and Research, FDA
Kavita Shah Arora, University of North Carolina at Chapel Hill
Diane Spatz, University of Pennsylvania
Brownsyne Tucker Edmonds, Indiana University
Raman Venkataramanan, University of Pittsburgh
Michelle Vichnin, Merck
Carmen Zorrilla, University of Puerto Rico
[1] Blehar, M. C., C. Spong, C. Grady, S. F. Goldkind, L. Sahin, J. A. Clayton. 2013. Enrolling Pregnant Women: Issues in Clinical Research. Women’s Health Issues. 23(1).
[2] Mastroianni, A. C., L. M. Henry, D. Robinson, T. Bailey, R. R. Faden, M. O. Little, A. D. Lyerly. 2017. Research with Pregnant Women: New Insights on Legal Decision-Making. Hastings Center Report. 47(3) 38-45.
[3] Task Force on Research Specific to Pregnant Women and Lactating Women. 2020. Report Implementation Plan. https://www.nichd.nih.gov/sites/default/files/inline-files/PRGLAC_Implement_Plan_083120.pdf (accessed August 31, 2021).