What just happened?
A federal judge in Texas issued an order late Friday afternoon (April 7) that could halt prescription use of the abortion pill. The judge sided with a coalition of pro-life groups that brought the case challenging the drug’s approval by the U.S. Food and Drug Administration (FDA), which occurred in 2000 during President Clinton’s second term. The judge has imposed a temporary injunction against the distribution of the abortion pill.
“The Court does not second-guess FDA’s decision-making lightly but here, FDA acquiesced on its legitimate safety concerns—in violation of its statutory duty—based on plainly unsound reasoning and studies that did not support its conclusions,” said the judge.
The preliminary injunction is scheduled to take effect in seven days. During that time, the Biden administration will seek emergency relief to appeal the decision. However, according to Axios, legal experts say drug manufacturers and distributors must immediately cease the sale and shipment of mifepristone for abortion use.
What is this court case about?
According to Alliance Defending Freedom (ADF), the lawsuit was brought by the Alliance for Hippocratic Medicine’s member organizations, which include major medical groups such as the American College of Pediatricians, the American Association of Pro-life Obstetricians and Gynecologists, and the Christian Medical & Dental Associations. In response to concerns about the FDA’s actions, the group submitted a citizen petition to challenge the FDA’s approval in 2002. Fourteen years later, the FDA denied their petition.
In 2016, on the same day it rejected the citizen petition, the FDA expanded the availability of chemical abortion drugs from seven weeks of pregnancy to 10 weeks, changed the dosing regimen, reduced the number of required in-person doctor visits from three to one, expanded who could prescribe and administer chemical abortion drugs beyond medical doctors, and eliminated the requirement for prescribers to report nonfatal complications from chemical abortion drugs.
The Alliance for Hippocratic Medicine submitted another citizen petition to challenge these changes but was again denied by the FDA.
In April 2021, during the COVID-19 pandemic, the FDA eliminated the remaining safeguards by removing the requirement that an abortionist physically meets with the woman and gives her the chemical abortion drugs, thus allowing for chemical abortions by mail and telemedicine. In December 2021, the FDA made this change permanent.
ADF attorneys filed a lawsuit challenging the FDA’s approval of chemical abortion drugs and subsequent removal of the protections for prescribing the drug. ADF asked the court to order the FDA to withdraw these dangerous chemical abortion drugs from the market.
What is the abortion drug that was approved by the FDA?
An abortion drug is a type of abortifacient, a chemical or drug that causes embryonic death by either killing the child directly or by preventing implantation of the embryonic child in the uterine lining. The term abortifacient means “that which will cause a miscarriage,” derived from the Latin abortus (miscarriage) and faciens (making). (A miscarriage is a form of unintended “spontaneous abortion” as opposed to an “elective abortion,” which occurs when a person takes measures to end the life of the child in the womb.)
The most common legal drug approved by the FDA to serve solely as an abortifacient (rather than as birth control that may have an abortifacient effect) involves the use of two drugs: mifepristone and misoprostol.
Mifepristone (known as Mifeprex or RU-486) ends a pregnancy by blocking the hormone progesterone, which is needed to maintain a pregnancy. Because this hormone is blocked, the uterine lining begins to shed, removing the child (in the embryonic state) that was attached. The second step, which occurs 24 to 48 hours later, requires taking misoprostol, a drug that causes the woman’s uterus to expel the child and the uterine lining in a manner similar to a miscarriage.
Why did it take two decades for the FDA decision to be challenged in court?
On the first page of its ruling, the court asks, “Why did it take two decades for judicial review in federal court? After all, Plaintiffs’ petitions challenging the 2000 Approval date back to the year 2002, right?”
Simply put, FDA stonewalled judicial review—until now. Before Plaintiffs filed this case, FDA ignored their petitions for over sixteen years, even though the law requires an agency response within “180 days of receipt of the petition.” But FDA waited 4,971 days to adjudicate Plaintiffs’ first petition and 994 days to adjudicate the second. Had FDA responded to Plaintiffs’ petitions within the 360 total days allotted, this case would have been in federal court decades earlier. Instead, FDA postponed and procrastinated for nearly 6,000 days. [emphasis in original]
How would a ban on the abortion pill affect abortions in the U.S.?
The two broad methods for legal abortions in the U.S. are medical and surgical. In a surgical abortion, the child in utero is dismembered and body parts are removed by suction (aspiration) through a thin tube inserted into the uterus.
The other method is a medical abortion, sometimes referred to as a medication abortion, chemical abortion, or pharmaceutical abortion. This method uses an abortifacient to stimulate uterine contractions similar to miscarriage. Medication abortion now accounts for about 54 percent of all abortions.
If mifepristone is prohibited, abortionists could still prescribe misoprostol, the other drug used in the two-drug combination. Misoprostol is already being used for medication abortions in countries where mifepristone is illegal or unavailable. However, the rate of effectiveness at causing an abortion is lower when only one of the drugs is used, and it might be more difficult to get insurance coverage for a misoprostol-only abortion due to its off-label use.
While it wouldn’t completely eliminate medication abortions, the ban on mifepristone could have a significant effect in reducing abortion and thereby protecting the lives of innocent children in the womb.