This translation will be reviewed.
Medication abortion is at the heart of a landmark case in the United States of America (USA). The American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG) and other plaintiffs (such as The Alliance for Hippocratic Medicine) have filed a lawsuit against the United States Food and Drug Administration (FDA) for illegally approving Mifepristone et misoprostol for chemical abortion. They ask the United States District Court for the Northern District of Texas to hold FDA’s review, approval, and deregulation of chemical abortion drugs unlawful and set them aside. In fact, these dangerous drugs harm women and girls. Abortion with Mifepristone and misoprostol has four times the risk of complications as compared with surgical abortions.
The FDA approved chemical abortion in 2000 (« the 2000 Approval »). The FDA imposed some restrictions. The drugs were limited to women and girls with unborn children aged seven-weeks gestation or younger. Furthermore, the FDA required three in-person office visits (the first to administer Mifepristone, the second to administer misoprostol and the third to assess any complications). Abortionists were also trained to report all adverse events from the drugs. However, since the 200 Approval, the FDA has repeatedly removed necessary safeguards meant to decrease the risk of serious harm to women. In 2016, the FDA approved several changes to the chemical abortion drug regimen including increasing the maximum gestational age from seven-weeks gestation to ten-weeks gestation. From 10 weeks, the baby measures about 1.2 inches long and their organs are formed. You can see a rounder head, and lots of little developments like eyes, fingers, toes and tooth buds. The FDA also allowed non-doctors to prescribe and administer chemical abortions pills and eliminated the requirement for prescribers to report non-fatal adverse events from chemical abortions. In 2021, the FDA removed the « in-person dispensing requirement » by allowing mail order abortions/ abortifacients to be mailed. With this unsupervised medical approach, women are completely alone in this traumatizing experience where they can even see their unborn child.
In France, 223 000 abortions were performed in 2021. According to a study conducted by the « Direction de la recherche, des études, de l’évaluation et des statistiques (DREES) » in september 2022, medication abortions represent two thirds of the abortions performed in French healthcare institutions. It means that in 2021, around 148 866 medication abortions were performed.
Whether it is in the US or in France, the chemical abortion regimen consists of two drugs: mifepristone and misoprostol. Mifepristone (also known as RU-486, Mifeprex or Mifegyne) is a progesterone blocker. Progesterone is essential to the development of the unborn human during pregnancy. (By blocking this hormone, Mifepristone halts nutrition and starves the unborn human until death). To complete the abortion, Misoprostol is then taken within 24 to 48 hours after Mifepristone. Misoprostol induces cramping and contractions to expel the unborn child from the mother’s womb. The plaintiffs who are doctors and national medical associations that provide healthcare for pregnant and post-abortive women and girls, challenge the 2000 Approval of the chemical abortion regimen for Mifepristone. The FDA has simply ignored their petitions for over sixteen years. Nonetheless, the plaintiffs are now seeking a preliminary injunction ordering the defendants to withdraw the FDA’s 2000 Approval of Mifepristone. In fact, the FDA have failed to protect the health, safety and welfare of women and girls by never studied the safety of these drugs under the labeled conditions of use. The FDA has also ignored the side effects of abortion drugs. Complications that accompany chemical abortions are severe pain, blood clots, heavy and/or prolonged bleeding for multiple weeks and undetected ectopic pregnancy which is life-threatening. Therefore, the plaintiffs are asking the District Court to remove Mifepristone from the list of Approved Drugs because pregnancy is not an illness and that the term “drug” implies health, and the intent of chemical abortion is to cause death of the unborn human.
On the 7th of April 2023, Judge Matthew J. Kacsmaryk, a federal district court judge in Texas, ruled that the 2000 Approval (of Mifepristone) was unlawful. In fact, the FDA did not have the authority to approve the chemical abortion drugs because it did not respect the required conditions associated with the use of fast-track approval, called Subpart H. Subpart H or “Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses” only applies to serious or life-threatening illnesses, such as HIV or cancer. However, this expedited review can only apply to drugs that satisfy two requirements. The drug must have been “studied for its safety and effectiveness in treating serious or life-threatening illnesses”. And the chemical abortion drugs must provide “meaningful therapeutic benefit” to the patients.
The FDA labeled pregnancy as “an illness” to conclude that chemical abortion drugs provide “meaningful therapeutic benefit” and to justify this review process. Nevertheless, as Judge Kacsmaryk held, “pregnancy is not an illness” but “a natural physiological state that most women experience” during their lives. Complications and negative physiological effects arising from pregnancy” must be distinguished from pregnancy that cannot be classified itself as an illness. Even the Population Council, an international non-governmental organization specialized in developing contraceptives, held that the use of Subpart H was unlawful because this process “does not comprehend normal and everyday occurrences such as pregnancy”. Therefore, the FDA did not respect the first requirement of Subpart H and then exceeded its authority to approve chemical abortion drugs under Subpart H.
Moreover, Judge Kacsmaryk, following the reasoning of the plaintiffs, held that the FDA also exceeded its authority under the second requirement of Subpart H. Mifepristone does not provide “meaningful therapeutic benefit” to patients. Since that pregnancy is not an illness, chemical abortion drugs cannot be “therapeutic” because it does not relate to the treatment or curing of disease. Chemical abortion drugs cannot provide “meaningful therapeutic benefit” to patients because of severe adverse events: post-abortion pain occurs in more than 77% of cases of Mifepristone use compared to 10.5% in surgical abortions.
Furthermore, Judge Kacsmaryk pointed out that the FDA violated the 1873 Comstock Act which prohibits the use of U.S. Postal Service to send abortion-inducing drugs or devices. With mail-order abortions and the removing of the “in-person dispensing requirement” in 2021, the FDA is clearly violating this federal law. The FDA tries to explain that the Comstock Act does not prohibit the mailing of items designed to produce abortions “where the sender does not intend them to be used unlawfully”. They argue that where chemical abortion pills are allowed by state law, breaking the federal prohibition is not an issue. However, Judge Kacsmaryk held that this argument is totally irrelevant. In fact, the Comstock Act says nothing about lawful or unlawful intent of the sender. Therefore, and in accordance with a well-established principle of law, “where the law does not distinguish, we must not distinguish either”.
After this landmark ruling for women’s health and for the protection of unborn life, the Biden administration appealed, and the Fifth Circuit Court of Appeals issued a ruling partially affirming the district Court decision. The Fifth Circuit blocked Kacsmaryk’s order to the FDA to revoke approval of the drug. Nonetheless, it reinstates some necessary safeguards (meant to decrease the risk of serious harm to women and girls). In fact, the Fifth Circuit prohibits the distribution of Mifepristone through the mail, protects women and unborn babies after seven-weeks gestation from Mifepristone and reinstated in-person visits. Both the US Department of Justice and Danco Laboratories (the defendants) appealed the restrictions on Mifepristone to the US Supreme Court. On April 21st, the Supreme Court granted a stay of the lower court decision and ordered to retain full access to Mifepristone as the appeal proceeds. This is until the Fifth Circuit opines on the merits of the lawsuit and the Supreme Court has the option of reviewing the decision. The Fifth Circuit will consider oral arguments on abortion pills on May 17th.
It should also be noted that there is a mean of attempting to reverse the effects of Mifepristone and to save unborn babies. Abortion Pill Reversal (APR) uses natural progesterone to nullify the effects of Mifepristone. The chances of the baby surviving increase from 25% (without natural progesterone) to 68% (with natural progesterone). This mean to stop abortion gives a real hope of saving unborn babies but unfortunately this will to bring to bring help to distressed women is greatly hindered by certain laws. It is especially the case in Colorado where the democratic governor signs a bill which bans APR on April 14th and punishes any professional who injects progesterone even in a woman who ask for it. Bella Health and Wellness (a pro-life health care clinic) filed a legal challenge to this APR ban. Judge Daniel Domenico then issued a temporary restraining order which halts the enforcement of the APR ban on this clinic until some medical boards weigh in on whether APR is a “generally accepted standard of practice”. If not, there will be unfortunately no reason to lift the prohibition.
To conclude, the Texas decision allows to put forward and confirm what pro-life associations and doctors were working on who affirmed the dangers of chemical abortions. Although France does not have a legal system equivalent to that of the US, this decision is a tremendous win for the protection of women and unborn life and should be emulated.
 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 ».