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Keywords: Induced Abortion

A Critical Analysis of the FDA’s 2021 Mifepristone REMS Modification Rationale Review

Mifepristone was first approved in 2000 in conjunction with misoprostol to induce abortion, and both its initial approval and subsequent regulation have been controversial. In 2021, the Food and Drug Administration (FDA) undertook a full review of the mifepristone Risk Evaluation and Mitigation Strategy (REMS) program, with the aim of assessing the necessity of each of the three Elements to Assure Safe Use (ETASUs) present in the mifepristone REMS, including ETASU C, the “in-person dispensing requirement.” Following this review, the FDA concluded that ETASU C could be safely removed and that mifepristone could be safely dispensed outside of the previously approved settings. This paper seeks to critically analyze the 2021 REMS Review, as well as the studies cited therein to determine whether the evidence presented by the FDA sufficiently substantiated this decision.

Risk factors predictive of post-abortion distress demonstrate that most abortions are contraindicated: A retrospective cross-sectional study.

Woman sits on a bed in a dark sweater, head bowed and hands covering her face, in a dimly lit bedroom with a bedside lamp and plant on the nightstand.

For physicians respecting the time-honored Hippocratic Oath, it is clear that induced abortion is a moral evil precisely because it involves the deliberate destruction of a human life.  But there is also clear evidence that induced abortion is an independent risk factor for cardiovascular disease, gestational diabetes mellitus, thyroid-related diseases, placenta-related diseases, and Asherman syndrome increased risk of premature and low birth weight deliveries in subsequent pregnancies, and premature death from multiple causes.  Even more common than physical sequelae, abortion is an independent risk factor for the onset or worsening of mental illnesses, as demonstrated in both record linkage studies and case-control studies.  These and other studies have firmly established that abortion may trigger, exacerbate, complicate or otherwise contribute to new or existing mental illnesses. 

A Statement on Abortion by 170 Obstetricians/Gynecologists after the  Reversal of Roe v Wade

In a recent American Journal of Obstetrics and Gynecology, 900 professors submitted a Special Report calling for reinstating federal protection for abortion. Here, we provide an alternative consensus statement. Induced abortion is not a constitutional right. We, too, value patient autonomy, but autonomy does not allow for causing harm to another human being, in this case, the human fetus. We share concern about maternal mortality in the United States, but evidence shows that induced abortion increases, not decreases, maternal mortality.

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