Case 2:22-cv-00223-Z Document 137 Filed 04/07/23 Page 4 of 67 PageID 4426
of mifepristone and its subsequent monitoring of the drug.[1] Then-Chairman Souder remarked that mifepristone was “associated with the deaths of at least 8 women, 9 life-threatening incidents, 232 hospitalizations, 116 blood transfusions, and 88 cases of infection.”[2] Additionally, Chairman Souder noted “more than 950 adverse event cases” associated with mifepristone “out of only 575,000 prescriptions, at most.”[3] The subsequent Staff Report concluded that FDA’s approval and monitoring of mifepristone was “substandard and necessitates the withdrawal of this dangerous and fatal product before more women suffer the known and anticipated consequences or fatalities.”[4] The report stated the “unusual approval” demonstrated a lower standard of care for women, “and [mifepristone’s] withdrawal from the market is justified and necessary to protect the public’s health.”[5]
FDA rejected the 2002 Petition on March 29, 2016 — nearly fourteen years after it was filed. ECF No. 7 at 9. That same day, FDA approved several changes to the chemical abortion drug regimen, including the removal of post-approval safety restrictions for pregnant women and girls. Id. at 10. FDA increased the maximum gestational age from seven-weeks gestation to ten-weeks gestation. Id. And FDA also: (1) changed the dosage for chemical abortion; (2) reduced the number of required in-person office visits from three to one; (3) allowed non-doctors to prescribe and administer chemical abortions; and (4) eliminated the requirement for prescribers to report non-fatal adverse events from chemical abortion. Id.
- ↑ See The FDA and RU-486: Lowering the Standard for Women’s Health: Hearing Before the Subcomm. on Crim. Just., Drug Pol’y, & Hum. Res. of the H. Comm. on Gov’t Reform, 109th Cong. 3 (2006) (“Subcommittee Report”).
- ↑ The transcript of the hearing before the House Subcommittee is available at https://www.govinfo.gov/content/pkg/CHRG-109hhrg31397/html/CHRG-109hhrg31397.htm.
- ↑ Id.
- ↑ Subcommittee Report at 40.
- ↑ Id.
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