SWHR Comments on FDA Draft Guidance on Post-Approval Pregnancy Safety Studies

Policy Engagement

Published 7/8/19

SWHR provided comments to the Food and Drug Administration (FDA) on its recently released draft guidance pertaining pregnancy safety study design.

SWHR emphasized the paucity of human data on drug safety and efficacy in pregnant woman due to the historical exclusion of pregnant woman in research. This exclusion created significant gaps in scientific information, which can lead to uncertainty regarding how best to prescribe medications to women during their pregnancies.

SWHR supported the three approaches FDA recommended within the draft guidance — pregnancy registries, pharmacovigilance, and complementary data sources — but urged FDA to expand on the discussion regarding the latter two approaches. SWHR’s comments also encouraged the FDA to recommend the use of complementary study designs as well as to further consider how researchers can overcome participant recruitment and retention barriers.

Read SWHR’s Comments