Exploring Strategies for Testing Medical Products on Pregnant and Lactating Women

Applied Clinical Trials

The National Institutes of Health (NIH) focuses on developing strategies that will encourage further research to support safe and effective therapies for pregnant and lactating women.

Under a provision of the 21st Century Cures Act approved by Congress last December, the National Institutes of Health (NIH) has launched a process for identifying policies and strategies likely to encourage more research on safe and effective therapies for pregnant and lactating women, including the ethical issues related to enrolling such patients in clinical trials. About half of some 6 million pregnant women in the U.S. take at least one medication, even though few drugs are specifically studied and approved for use during pregnancy and for nursing mothers.

The Cures legislation instructs NIH’s Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHHD) to establish a Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) with the aim of advising the research and drug development community on how to obtain reliable evidence in this area [see https://www.nichd.nih.gov/news/releases/Pages/060717-PRGLAC.aspx ]. Officials from leading federal health agencies, including FDA’s Office of Women’s Health (OWH), held an initial meeting Aug. 21-22, 2017, to examine the current state of research and key issues involved in establishing the task force and its work plan. The aim is to develop recommendations for regulators, researchers, health professionals and industry on how to obtain needed information on safe and effective medicines for women during pregnancy and after delivery.

The task force will examine how these issues relate to a full range of medical therapies, including vaccines, dietary supplements, and prescription drugs, in assessing what information stakeholders feel is important to be included in product labels. There is interest in exploring how approaches differ for existing therapies vs. drugs in development and to better understand what data is already available, common terminology, data standards, use of registries, and clinical trial networks capable of conducting future studies.

At the initial August meeting, Marjorie Jenkins, director of medical initiatives and scientific engagement in FDA’s Office of Women’s Health, outlined FDA initiatives in this area. Top NIH and NICHHD officials, plus representatives of the Centers for Disease Control and Prevention, the Agency for Healthcare Research & Quality, the National Vaccine Program Office, the Department of Defense, and the Department of Veterans Affairs also discussed previous and current research and ongoing challenges in obtaining needed information.

The next meeting is November 6-7, 2017, and additional sessions are scheduled for February and May 2018. A main topic for discussion is the ethical issues involved in including pregnant and lactating women in clinical trials.

FDA initiatives

FDA’s Office of Women’s Health has been examining these issues and funding relevant research projects for several years. A main task since 2015 has involved implementing a new regulation on providing more information for the pregnancy and lactation subsections of drug labeling. Areas of OWH research range from whether predictive modeling may help anticipate how pregnant women might respond to a drug without participating in a clinical trial, to the likely impact of Zika on pregnant women and their babies.

A leading OWH initiative is to encourage pregnant women to enroll in registries for certain drugs or diseases to help assess whether a therapy used to manage medical conditions such as asthma, diabetes or high blood pressure raises special concerns. FDA can steer women and health professionals to more than 40 registries and additional resources on medication use during pregnancy, explained OWH deputy director Pamela Scott in a blog recently posted on the FDA website [see https://blogs.fda.gov/fdavoice/index.php/2017/08/working-to-improve-information-on-medication-use-during-pregnancy/].

The PRGLAC task force is slated to issue a report in two years that identifies federal research activities involving pregnancy and lactation, where further studies are needed to support the development of safe and effectives therapies for this population, and effective strategies for communicating relevant information to patients and health care providers. Representatives of industry, medical societies and nonprofit organizations are slated to make up at least one-third of the panel.