Medical abortion is at the heart of a new legal battle in the United States. Several doctors, as well as pro-life associations, such as The Alliance for Hippocratic Medicine and The American Association of Pro-life Obstetricians and Gynecologists (AAPLOG), filed a petition before Texas federal judge Matthew J. Kacsmaryk requesting the withdrawal of the marketing authorization for mifepristone, which is used for medical abortions. Indeed, far from being harmless, this type of abortion would involve four times more risks of having complications than a surgical abortion, according to an American study.
By Domitille Ballabas
The U.S. Food and Drug Administration (FDA) marketing authorization decision to distribute mifepristone in 2000 was accompanied by a few additional measures. Then, women could only take mifepristone until the seventh week of pregnancy. Women were also required to attend three medical visits (before, during, and after taking mifepristone) and notify of any possible side effects. Since that decision, the FDA has worked steadily to reduce what it sees as barriers to its use. Indeed, the FDA has consistently withdrawn the already meager security measures. In 2016, the FDA lowered the number of medical visits initially required and extended the possibility of having a medical abortion from seven weeks to ten weeks of pregnancy. At ten weeks, the fetus measures five to seven centimeters, the internal organs are present, and the fetus’ face is visible with all the characteristic features of a human being. The FDA also allowed non-physicians to prescribe and administer mifepristone and misoprostol and removed the requirement to report side effects as long as they are not fatal. During the Covid-19 pandemic, the FDA suspended the requirement to visit a doctor in person, instead authorizing the shipment of the pills necessary for medical abortion directly to homes. With this lack of medical supervision, women are then doomed to expel the small, dead fetus with intense bleeding without proper medical supervision. As a result, these women see the body of a tiny dead baby with their own eyes, which can cause significant trauma.
In France, 223,000 abortions were performed in 2021. According to a study conducted by the Department of Research, Studies, Evaluation, and Statistics (DREES) in September of 2022, voluntary interruptions of pregnancy through medication represented two-thirds of the abortions performed in French health establishments; thus, 148,866 out of 223,000 abortions are medical abortions.
Whether in France or the United States, medical abortion occurs by taking two kinds of pills. The first, mifepristone (or RU-486, Mifeprex, or Mifegyne), is an anti-progesterone. Anti-progesterones block the production of progesterone, a hormone naturally created by the female body and necessary for pregnancy. Misoprostol, the second pill, must then be taken 24 to 48 hours after taking mifepristone. Misoprostol causes the contractions and expulsion of the embryo. It is mainly against mifepristone that certain associations and doctors have filed a petition. For over sixteen years, the applicants have continually requested that the FDA review its authorization for mifepristone. As shown by these continual requests, the applicants believe that the FDA did not respect the necessary safety measures before approving the marketing of this product. Furthermore, the applicants highlight the medical complications mifepristone can cause. Such as significant hemorrhages (including the expulsion of blood clots), severe pain, and ectopic pregnancies that endanger the mother's life. The petitioners, therefore, request the removal of mifepristone from the list of authorized “drugs” because pregnancy is not a pathological condition, and what is called a “drug” does not constitute a cure but on the contrary, prevents the development of life.
On April 7, 2023, Judge Matthew J. Kacsmaryk suspended the marketing authorization for mifepristone issued in 2000 by the FDA. He suspended the authorization because the FDA did not meet the necessary conditions for using the “Subpart H” fast-track procedure, which makes the authorization of mifepristone illegal. Indeed, the procedure known as Subpart H or “Accelerated Approval of New Drugs for Serious Life-Threatening Illnesses” only applies if two conditions are met. First, the drug must prove to be safe and effective in the treatment of serious or life-threatening illnesses. Second, the drug must provide an important therapeutic benefit to the patient.
The FDA classified the pregnancy as a serious or life-threatening illness and concluded that mifepristone provided significant therapeutic benefits to the patient in order to use the expedited procedure. However, as Judge Kacsmaryk points out in his reasoning, pregnancy is not a disease but a natural process many women face daily. The complications or psychological effects which can cause disease are separate from pregnancy. Even the American non-governmental organization specializing in the promotion of contraception, the Population Council, has recognized that the use of the Subpart H process is illegal because pregnancy is not a serious or life-threatening illness. Thus, as Judge Kacsmaryk concluded, the first requirement for the use of this expedited procedure to approve mifepristone has not been met.
Regarding the second requirement, Judge Kacsmaryk agrees with the petitioners' reasoning that mifepristone does not provide significant therapeutic benefits to the patient. Since pregnancy itself is not a disease, medical abortion simply cannot provide therapeutic benefits. Medical abortion is not therapeutic because the term “therapeutic” attaches to healing, to the relief of illnesses, which does not apply to pregnancy. Rather than providing healing, medical abortions cause potential complications. As shown by the occurrence of post-abortion pain in more than 77% of cases of mifepristone, whereas only 10.5% of surgical abortion cases cause post-abortion pain.
Additionally, Judge Kacsmaryk points out that the FDA violated the Comstock Act, an 1873 law prohibiting abortifacient shipment. The FDA admitted to using the postal route to supply mifepristone and misoprostol in 2021, which clearly violates this Act. The FDA then tried to explain that the Comstock Act did not prohibit the shipment of abortifacients as long as its use was legal. Judge Kacsmaryk refutes this excuse, in accordance with a well-established principle of law: no mention is made in this law concerning the legal or illegal use of these abortifacients. Therefore, "[w]here the law does not distinguish, neither should we distinguish."
Following this decision, on April 12, 2023, the U.S. Department of Justice appealed to the Fifth Circuit Court of Appeals. The Court of Appeals temporarily blocked the suspension decision taken by Judge Kacsmaryk. However, this jurisdiction has regulated the use of mifepristone by prohibiting its obtainment through postal service and its prescription by persons other than doctors. The Court of Appeals also returned the period of use for mifepristone to its original seven-week limit. In response, the U.S. Department of Justice ordered the U.S. Supreme Court to suspend the decision of the Court of Appeals. Thus on April 21, 2023, the U.S. Supreme Court held that mifepristone should always be accessible. However, this decision is temporary until the “Fifth Circuit Court of Appeals” rules on the merits of the case. But this does not mean that the Supreme Court ruled in favor of the validity of the FDA approval of mifepristone. First, we must wait for the final decision of the “Fifth Circuit Court of Appeals” which will be rendered after the pleadings of May 17. Following this decision, the U.S. Department of Justice or pro-life associations
Also, notably, there is a way to try to save the child if the mother-to-be regrets her choice to abort. This method is called “abortion pill reversal” and involves the woman injecting progesterone into her body within hours of taking mifepristone. This natural hormone tries to save the baby by countering the effects of mifepristone. The studies conducted on this method show that the baby's chances of survival go from 25% (without natural progesterone) to 68% (with natural progesterone). Unfortunately, this ability to help distraught women is greatly hampered by certain laws. As was the case with the law adopted on April 14, 2023, by the Colorado governor, which prohibits this means of saving lives and punishes any health professional who would even inject it into a woman by requesting it. The “Bella Health and Wellness” clinic has so far succeeded in obtaining the suspension of this law by Judge Daniel Domenico until some Medical Boards conclude whether this means of countering mifepristone is a “general[y] accepted practice.” If the Boards conclude it is not an accepted practice, the law will, unfortunately, prohibit its use.
Finally, the decision of Judge Kacsmaryk highlights and confirms what the pro-life associations were working on, as well as the many American health professionals who affirmed the dangers of the substances used during medical abortions. Although France does not have a legal system equivalent to that of the United States, this decision constitutes a legitimate step forward for the protection of women and future newborns from which France should draw inspiration.
 Camilleri C, Beiter R, Puentes L, Scherk P, Sammut S. « Biologic, Behavioral and Physiologic Consequences of Drug-induced Pregnancy Termination at First-trimester Human Equivalent in an Animal Model. » Frontiers in Neuroscience.
 Sentence issue du droit romain : « Ubi lex non distinguit, nec nos distinguere debemus ».