Case: 23-10362 Document: 543-1 Page: 6 Date Filed: 08/16/2023
in France. The studies purported to show that mifepristone was effective in the majority of cases, under the conditions imposed in each study. Those conditions included: an ultrasound to verify gestational age and diagnose ectopic pregnancies; that prescribing physicians have experience performing surgical abortions and have admitting privileges at a nearby hospital; that the testing facilities be located close to a local hospital; and a four-hour monitoring period after taking misoprostol.
Although mifepristone was effective for most patients, the studies showed a trend of adverse events for some women. According to FDA, “surgical intervention” was required in 7.9% of the subjects in the American trial and 4.5% of subjects in the French trials. The reasons for surgery included heavy bleeding, infection, incomplete abortion, and ongoing pregnancy—meaning that the embryo or fetus continued to grow and develop.
FDA approved the new drug application in September 2000. The letters that the agency sent to the Population Council explained that the approval was “under Subpart H.” FDA Approval Memorandum to Population Council at 6 (Sept. 28, 2000). This was for two reasons. First, FDA understood Mifeprex to be a drug that treated a serious or life threatening illness. Id. (“FDA has determined that the termination of an unwanted pregnancy is a serious condition within the scope of Subpart H. The meaningful therapeutic benefit over existing surgical abortion is the avoidance of a surgical procedure.”). And second, Subpart H was required because Mifeprex could not be administered safely without imposing certain use restrictions. Id. (“Subpart H applies when FDA concludes that a drug product shown to be effective can be safely used only if distribution or use is restricted….”).
In order to address the safety risks discussed above, FDA imposed several safeguards. First, it required the following black-box warning:
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