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Misplaced Fears Leave Pregnant Subjects Out Of Drug Trials

Associate Madison Castle and Of Counsel Kate Stewart spoke with Law360 about the exclusion of pregnant and lactating individuals from clinical trials for drugs and devices, stemming from previous concerns over legal liability. 

Madison said, “Looking at the historical context of why pregnant women are excluded from these studies is important,” referencing a period when the use of thalidomide by pregnant people to treat nausea resulted in thousands of birth defects.

Kate expressed interest in seeing the FDA’s diversity action plan guidance, commenting, “I don’t think you’re going to see real action on this until FDA issues guidance and creates incentives for the inclusion of this population.”