Higher courts suspend the decision pending hearing appeals

Paul Tuns:

On April 7, U.S. Federal Judge Matthew Kacsmaryk of the Amarillo Division of the Eastern District, ruled in favour of a challenge to the Food and Drug Administration’s approval of the abortion drug mifepristone during the closing months of the Clinton administration. Within two weeks, the decision was partly set aside by the Fifth Circuit Court of Appeal, but was later completely blocked by the Supreme Court of the United States pending appeals. Despite the uncertainty of the appeals against Kacsmaryk’s decision, it was a remarkable ruling that outlined the potential and real harms the abortion pill presents to mother, child, and the medical profession, shone a light on the political decision of the FDA to approve the drug, and condemned the agency’s relaxation of regulations governing mifepristone.

The case was brought before his court by the Alliance Defending Freedom on behalf of the Alliance for Hippocratic Medicine last November and argued in March. Mifepristone is one-half of the abortion drug regiment along with misoprostol. Mifepristone blocks the hormone progesterone which is need for a preborn child to develop inside the uterus; blocking progesterone effectively starves the embryonic child to death. Misoprostol, a drug that was approved to treat ulcers, is usually taken within 24 hours of the first drug and it causes uterine cramping and cervical softening in order to expel the tiny child from the body. The drugs are typically taken in the first eight to ten weeks of pregnancy, and U.S. studies show that it is effective at ending the pregnancy 95 per cent of the time; in the other five per cent of cases, the mother must undergo a surgical abortion to kill and remove her preborn baby.

In a decision released on Good Friday, April 7, Kacsmaryk found the FDA did not abide its own rules for approving the drug and found that the Alliance, as well as members of both the Christian Dental and Medical Associations and the Catholic Medical Association, had standing in which to challenge the FDA’s approval because he was convinced by their argument that they are forced to deal with women admitted to emergency rooms to deal with complications resulting from the chemical abortions, including completing abortions that were unsuccessful after taking the two-drug regiment. He issued a preliminary injunction suspending the FDA’s approval of mifepristone and its subsequent relaxation of regulations governing its dispersal.

Kacsmaryk, a Donald Trump appointee to the federal bench, used language that typically seen in judicial decisions. He eschewed use of the term “fetus” and used “unborn human” and “unborn child,” noting that fetus is a particular stage of prenatal development that does not accurately describe the victims of abortion. He called the abortion pill, a “chemical abortion” and those who carry out abortions “abortionists.” The New York Times scoffed that he “repeatedly used the language of abortion opponents.” In this alone, the opinion was monumental – the Daily Signal’s Sarah Parshall Perry said the “best part” of the ruling came down to two words: “unborn human.” Kacsmaryk, who worked the First Liberty Institute, a Christian legal group, and served on the board of directors of a pregnancy care centre (that saved the life of his sister’s preborn child when she was in university), and those credentials caused many in the media to question his impartiality. Pro-lifers argued that his experience led him to analyze the case through a more realistic lens. Parshall Perry said, “the humanizing language of Kacsmaryk’s opinion, its recognition of the dangers of mifepristone to both mother and child, and its accurate recitation of facts to which the abortion lobby prefers to turn a blind eye make his opinion one with both impact and empathy.”

But his 67-page ruling is a clinical takedown of mifepristone and its approval, buttressed in law and logic. He noted that the FDA exceeded its authority when it fast-tracked the approval process for mifepristone by invoking Subpart H for “serious or life-threatening illness,” which Kacsmaryk emphatically said pregnancy was not. He further found FDA exceeded its authority when it later loosened regulations designed to ensure the abortion pill was prescribed as safely as possible.

When the FDA originally approved mifepristone, it limited to the abortion drug to seven weeks gestation and required three in-person doctor’s visits, among other restrictions. In 2016, the FDA raised the gestational limit to 10 weeks, reduced the required number of in-office visits to one, allowed non-doctors to prescribe mifepristone, changed the dosage, and eliminated the requirement that non-lethal adverse effects be reported. In 2021, as part of a suite of COVID policy changes, the FDA allowed mifepristone to be prescribed by telehealth appointments and dispensed through the mail; the following year, they made those policies permanent. Kacsmaryk also noted that the FDA failed in its duty to determine the safety of mifepristone by excluding any evaluation of the psychological or long-term harms of the abortion pill.

Kacsmaryk then chastised the FDA’s “stonewalled judicial review” that delayed a hearing on the plaintiff’s complaints and explained why the plaintiffs had standing to challenge the FDA’s approval, noting that the abortion pill’s availability puts enormous pressure on the medical system through emergency care and treating complications. He pointed to studies that found 77 per cent of women who underwent chemical abortions reported “a negative change” and 38 per cent suffered from “anxiety, depression, drug abuse, and suicidal thoughts because of the chemical abortion.” He pointed to one particularly distressing chemical abortion in which the “lifeless, fully formed baby” was delivered dead in a toilet at 30-36 weeks pregnancy despite the abortionist dated the baby’s gestational age as six weeks.

In his decision, Kacsmaryk said the loosening of regulations were not warranted and that FDA claims that the abortion drug was “safe” could not be supported by evidence, especially because it eliminated the requirement that adverse effects be reported, which Kacsmaryk also found that the FDA permitting mifepristone to be prescribed by telehealth and dispensed through the mail violated the Comstock Act, the 1873 law unanimously passed by Congress which prohibits the interstate mailing of abortifacients and is still on the books.

Kacsmaryk stayed his own order for one week to give time for the government to appeal his decision. Within an hour of the release of his ruling, Judge Thomas O. Rice, who Barack Obama appointed to the U.S. District Court for the Eastern District of Washington, issued an injunction against Kacsmaryk’s ruling from taking effect in the 17 U.S. states and the District of Columbia which had petitioned his Rice to prevent any order for the FDA to reduce the availability of mifepristone. As Kacsmaryk’s decision was national, the diametrically opposed decisions clashed and necessitated a quick appeal to the Fifth Circuit Court of Appeals.

The U.S. Justice Department, FDA, and Danco Laboratories, which manufactures mifepristone, appealed the decision.

Within a week, the Fifth Circuit Court’s three-member panel was unanimous in overturning Kacsmaryk’s suspension of the FDA’s approval of mifepristone, saying in a preliminary order that too much time had passed to challenge the FDA’s 2000 approval, ignoring Kacsmaryk’s finding of stonewalling. But in a 2-1 decision, the Court temporarily put the original restrictions back in place.

Shortly thereafter, the case was appealed the Supreme Court, which ruled 7-2 (with Justices Samuel Alito and Clarence Thomas dissenting) staying the lower court decisions suspending mifepristone approval and reversing the liberalization of the restrictions. The stay is temporary as the case will now be fully litigated before the Fifth Circuit later this month.

What happens now? The case will be heard by the Fifth Circuit Court of Appeals in mid-May and whatever the final ruling is there will certainly be appealed by one side or the other to the Supreme Court. In the meantime, mifepristone will be permitted in the exact same way as if Kacsmaryk never issued his ruling.

Even if the higher courts affirm Kacsmaryk’s decision, the FDA could choose not to enforce a regulation or prohibition of the drug if it deems chemical abortions safe or effective. The FDA could also declare that it does not have the resources to enforce the restrictions and turn a blind eye to drug manufacturers that distribute the drug and doctors who prescribe it. Or it could go through the approval process once again from scratch.

In the absence of any decision by the FDA, the New York Times reports that many women are utilizing foreign suppliers to obtain their abortion pills. Estimates vary, but the most common number is that 50,000 American women are obtaining illegal chemical abortions from foreign suppliers, mostly from India where it is made cheaply and sold in the U.S. for $300-$800. Aid Access, run by the Dutch abortionist Rebecca Gomperts, is a not-for-profit that claims to send 100 chemical abortion packages to U.S. patients per day. In 2019, the Food and Drug Administration warned Aid Access it was not authorized to distribute mifepristone or a generic version of the abortion drug, but relented when the organization sued the agency.

Many American abortionists – Planned Parenthood, telehealth prescribers, and family physicians – say they will dispense the second-half of the abortion pill regiment, misoprostol, which can be used on its own although it is less effective at completing the abortion on its own, with estimates ranging from 78-85 per cent effective at terminating the pregnancy; it is also more painful, with heavier cramping, more bleeding, and greater risk of serious complications, although the World Health Organization advises that in the absence of mifepristone, misoprostol can be used alone. With the lower rates of “effectiveness” (at killing the preborn child), with about eight-in-ten women who take only misoprostol will need to complete the abortion surgically. The Charlotte Lozier Institute’s Dr. Ingrid Skip said that misoprostol alone “is way less effective” than the two-drug regiment. She said meta-studies of misoprostol show that many women suffer serious infections and develop fertility problems or future pregnancy complications.

In the meantime, U.S. states governed by Democratic governors, are loading up on long-term supplies of the abortion drug. California Governor Gavin Newsom announced his state has acquired a five-year supply of two million abortion pills, even though the shelf-life of the drug is just two years. The state paid less than a dollar per pill with their mass order. Other states such as Massachusetts, New York, and Washington, were likewise stockpiling the abortion pill.

According to the pro-abortion Guttmacher Institute, more than half of all abortions in the United States are chemical abortions, with just under half being surgical abortions. Kacsmaryk’s decision could upend the current abortion landscape in the U.S., and, if his decision is allowed to stand, even in part, could give states that have banned abortion the tools to combat the illegal interstate and import trade of the abortion pill. And as Josie Luetke, director of Education and Advocacy at Campaign Life Coalition, told True North, “even if the drug isn’t removed from shelves, this decision and resulting media coverage are opening up the conversation about the harms of chemical abortion.”