Clinical Research in Pregnancy, the FDA, and the “Shadows of Thalidomide”

In the early 1960s, FDA reviewer Frances Kelsey courageously prevented the approval of thalidomide, a drug that would soon be linked to birth defects. Kelsey’s work averted a national tragedy and simultaneously facilitated major changes in the drug approval process in the United States. In this talk, I will revisit Kelsey’s enduring legacy, not only for contemporary clinical trials and the FDA’s reputation, but also for the durable impact her work and the thalidomide episode have had on regulatory and ethical thinking about clinical research in pregnancy. Although thalidomide’s shadows have long dimmed the prospects for research in pregnancy, archival data reveal that current calls for advancing research in pregnant populations in fact powerfully align with Kelsey’s legacy.