The Evolution of Pregnancy and Lactation Safety Studies in the US and Trends in FDA Post-Marketing Requirements/Commitments

FALL 2021, THE EVIDENCE FORUM, WHITE PAPER

Kristin Veley, PharmD, MPH Senior Research Scientist and Director REMS and Pregnancy Registries Real-World Evidence Evidera, a PPD business

Deborah Covington, DrPH, FISPE Senior Research Leader, Real-World Evidence Evidera, a PPD business

Payal Pozin, MPH Research Associate III, Real-World Evidence Evidera, a PPD business

Kat Downes, PhD, MPH Research Scientist, Real-World Evidence Evidera, a PPD business

Rebecca Morris Buus, PhD Senior Research Associate, Real-World Evidence Evidera, a PPD business

Lindsey Wilson, BS PPAS Data Collection, Real-World Evidence Evidera, a PPD business

Introduction

There is increasing interest in monitoring the safety of medication use during pregnancy and lactation. Studies to evaluate medication safety during pregnancy and lactation, as well as the regulatory initiatives in the United States (US) related to these studies have evolved over the past few decades. This paper examines:

• The history of pregnancy studies in the US
• The regulatory initiatives regarding pregnancy and lactation safety studies in the US
• The types of pregnancy and lactation safety studies currently required or recommended by the US Food and Drug Administration (FDA)
• Recent trends in post-marketing requirements (PMRs) and post-marketing commitments (PMCs) issued by the FDA for pregnancy and lactation safety studies and the potential impact of recent regulatory initiatives and guidance documents on these trends