Lozier Institute Amicus Brief in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration
With major international studies showing that the abortion pill regimen carries four times the risk of complications as surgical abortion, Charlotte Lozier Institute has filed an amicus brief asking the U.S. District Court for the Northern District of Texas to grant a preliminary injunction suspending the Food and Drug Administration’s (FDA) approval of the abortion pill.
The Lozier Institute amicus brief, filed in the Alliance for Hippocratic Medicine v. FDA case (AHM v. FDA) on February 10, 2023, details more than a dozen specific concerns with the FDA’s flawed approval.
SUMMARY OF ARGUMENT
The U.S. Food & Drug Administration (FDA) claims that “[b]enefit-risk assessment is the foundation for” the agency’s “regulatory review of human drugs and biologics.” But when it comes to abortion regulation, particularly chemical abortion regulation, that foundation is severely compromised.
The FDA’s chemical abortion regulations disregard serious risks and elevate speculative benefits. While the FDA claims that chemical abortion is safe, that conclusion ignores several critical factors. First, claims about abortion’s safety in general are unreliable given the lack of accurate abortion data and the misunderstanding of maternal mortality ratios. Second, claims about chemical abortion’s safety are equally unreliable given the lack of any systematic method for reporting complications despite the severity of those complications. And the reporting that does happen is underinclusive due to the frequent miscoding of chemical abortion complication as miscarriage.
Rather than address these issues, the FDA has exacerbated them by loosening the few restrictions that previously shielded women from some of these risks. The FDA’s new regulations now allows women to self-manage their chemical abortions without ever seeing a doctor in person. Yet the consequences of telemedicine chemical abortion are almost too numerous to count—lack of necessary ultrasounds to confirm gestational age and rule out ectopic pregnancy, inability to confirm that a woman is not being coerced to obtain an abortion, abandonment of women to deal with the medical and psychological repercussions of abortion by herself with no follow-up, and grave harm to physicians who are expected to clean up the mess (in the ER and elsewhere) of self-managed abortion.
No benefits outweigh these tremendous risks. While the FDA claims that the availability of chemical abortion is an economic benefit and more convenient for women, the data tell a different story. Although childbirth is costly in the short-term, the long-term economic benefits surpass those initial costs. And convenience and easy access are not a net benefit to women. Rather, the easy access of telemedicine abortion creates further risks for women, particularly those who are abused and disadvantaged. Simply put, there is no justification for the FDA’s risk-benefit analysis regarding chemical abortion.
FULL TEXT: BRIEF FOR AMICUS CURIAE CHARLOTTE LOZIER INSTITUTE IN SUPPORT OF PLAINTIFFS’ MOTION FOR A PRELIMINARY INJUNCTION