The Gist Healthcare Podcast Why Pregnant Women Are Still Missing From Drug Trials and Why It Matters Now
Oct 13, 2025
Lizzy Lawrence, a reporter for STAT News focusing on the FDA, sheds light on the long-standing exclusion of pregnant women from clinical drug trials. She discusses how the thalidomide crisis shaped current research practices, leading to significant knowledge gaps. Lawrence addresses the overreaction to past risks, highlighting the need for better data on commonly used medications like Tylenol. She also explores recent federal recommendations aimed at reintegrating pregnant individuals into trials and the ethical implications of this necessary change.
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A Regulator Who Said No To Thalidomide
- Frances Kelsey Oldham refused to approve thalidomide in the U.S., which helped prevent many birth defects.
- Her skepticism exemplified early regulatory caution that later became overbroad exclusion of pregnant women.
Thalidomide Shifted Drug Policy Forever
- The thalidomide crisis reframed how regulators view drug effects on fetuses and drove blanket exclusion of pregnant women from trials.
- That overcorrection created enduring gaps in knowledge about medication safety during pregnancy.
Assume Inclusion, Design For Pregnancy
- Experts pushed for a default of including pregnant women unless there is a clear reason to exclude them.
- Designing trials with obstetric expertise and proper funding can make inclusion feasible and safer.