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 to February 2019. That study noted 20 deaths, 529 life-threatening events, and 1,957 severe adverse events before concluding that a pre-abortion ultrasound “should be required to rule out ectopic pregnancy and confirm gestational age.”

The record confirms FDA once shared these concerns. After all, many tragedies could be avoided by auditing physician qualifications and requiring ultrasounds. In 1996, the FDA Advisory Committee expressed to the Population Council “serious reservations” on how the drugs were described “in terms of assuring safe and adequate credentialing of providers.” ECF No. 1-14 at 51. Population Council initially committed to conducting post-approval studies in 1996, and FDA reiterated these requirements mere months before the September 2000 approval. See ECF No. 1-24 at 6 (“We remind you of your commitments dated September 16, 1996, to perform the … Phase 4 studies.”). Those protocols would have required, inter alia, that the Population Council: (1) assess the long-term effects of multiple uses of mifepristone; (2) ascertain the frequency with which women follow the regimen and outcomes of those that do not; (3) study the safety and efficacy of chemical abortion in girls under the age of eighteen; and (4) ascertain the regimen’s effects on children born after treatment failure. ECF No. 1-28 at 32.