
Regulators Seek More Drug Effects Research Related to Pregnancy and Lactation
Regulators wish to expand and clarify methods for obtaining information on medicines used by or needed for pregnant and lactating individuals through clinical trials and postapproval studies.
Initiatives to learn more about the impact of drugs and medical products on diverse population groups is driving efforts to assess the effect of medicines and vaccines on pregnant and lactating patients. The aim is to expand and clarify methods for obtaining information on medicines used by or needed for this population through clinical trials and postapproval studies, as seen in a number of policy initiatives and expert assessments of ways to obtain reliable information on how drugs affect these patients.
Pregnant women traditionally have been excluded from preapproval studies due to concerns about potential damage to the health of the mother and the fetus. Unfortunately, that has created a serious dearth of useful information on safe treatments for this group, including individuals coping with serious conditions. While FDA has required sponsors to include in labeling available information on drug impact for this population, the agency does not require research sponsors to collect such data in clinical trials.
Yet the ongoing interest in including more pregnant and lactating women in clinical trials continues to generate research and strategies on the subject, as presented at a
More real-world data
Meanwhile,
FDA also seeks to
Seeking global standards
This issue, moreover, has gained international attention as part of efforts to advance research on women in a wider range of health conditions. The International Council for Harmonisation (ICH) agreed at its May 2022 meeting in Athens to add this topic to its list of issues warranting global standards. A proposal developed by officials at FDA, the European Medicines Agency (EMA), and the United Kingdom’s Medicines & Healthcare products Regulatory Agency (MHRA) calls for
Of note, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) recently
Many of these initiatives build on the report issued in 2020 by the national Task Force on Research Specific to Pregnant and Lactating Women (PRGLAC), which was initiated by the 21st Century Cures Act of 2016 to address gaps in knowledge and research on this topic. That
And biopharma companies agreed in the latest Prescription Drug User Fee Act plan (PDUFA VII) to support efforts to determine what data and post-market safety signals best indicate exposure to medication in pregnancy and how that may help assess the effects of drugs and vaccines in pregnant women. FDA will explore the use of pregnancy registries and electronic health record systems in establishing a standardized process for this purpose at a
About the author
Jill Wechsler is Washington editor for BioPharm International.
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