Case: 23-10362 Document: 543-1 Page: 7 Date Filed: 08/16/2023
If Mifeprex results in incomplete abortion, surgical intervention may be necessary. Prescribers should determine in advance whether they will provide such care themselves or through other providers. Prescribers should also give patients clear instructions of whom to call and what to do in the event of an emergency following administration of Mifeprex.
Approval Memorandum at 2. FDA also set the following controls on the use and prescription of Mifeprex:
- Only women whose pregnancies have a gestational age of forty-nine days or less are eligible;
- Only physicians can prescribe Mifeprex;
- All prescribing physicians must be able to assess gestational age, diagnose ectopic pregnancies, and “provide surgical intervention in cases of incomplete abortion or severe bleeding” or have arranged for another physician to provide such care;
- Prescription must occur in person; and
- Prescribers must report any “hospitalization, transfusion, or other serious event[] to the sponsor.”
Id. at 1, 6. Finally, FDA required three doctor’s-office visits, which are summarized as follows. The patient first takes mifepristone at the doctor’s office. Three days later, she returns to the office to take misoprostol. Finally, the patient visits the doctor for a follow-up appointment, to determine whether the drug has successfully terminated the pregnancy and to screen for any adverse effects.
In August of 2002, the American Association of Pro-Life Obstetricians and Gynecologists (a party to the instant case) and several other similar organizations filed a citizen petition, asking FDA to revoke its approval of mifepristone. See 21 C.F.R. § 10.30. The petition argued that mifepristone was not safe to use under the approved conditions. FDA reviewed the peti-
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