This is the 113-page brief given to the federal court in Texas:
https://adfmedialegalfiles.blob.core.windows.net/files/AllianceForHippocraticMedicineComplaint.pdf
Excerpts:
First, the FDA never had the authority to approve these drugs for sale. In 2000, the FDA approved chemical abortion drugs under 21 C.F.R. § 314, Subpart H (Subpart H). This regulation authorizes the FDA to grant “accelerated approval” of “certain new drug products that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit to patients over existing treatments.” 21 C.F.R. § 314.500 (emphasis added).
But chemical abortion drugs do not treat serious or life-threatening illnesses. Indeed, pregnancy is a normal physiological state that many females experience one or more times during their childbearing years.
chemical abortion drugs do not provide a “meaningful therapeutic benefit” to women and girls over existing treatments.
upwards of ten percent (10%) of women who takechemical abortion drugs will need follow-up medical treatment for an incomplete or failed chemical abortion,14 with an average of thirty-nine percent (39%) of women requiring surgery if taken in the second trimester.