An early April 2023 decision of a U.S. District Judge in Texas to 23 years of approval of the abortion pill mifepristone has led to explosive discussions.
Mifepristone is a medicine that blocks the receptors for the hormone progesterone, which is necessary for fetal development. It is part of a two-step abortion regimen along with misoprostol, a drug used to prevent stomach ulcers that also causes uterine contractions. Medication abortion with this two-step approach or a slightly less effective misoprostol-only regimen is now used more than half of all abortions in the U.S
The Food and Drug Administration approved mifepristone in the year 2000 for use in drug-induced abortions up to seven weeks. Along with the approval, the FDA also required a personal visit as an additional security measure. In 2016, the FDA extended its approval of mifepristone use to 10 weeks of pregnancy.
In January 2023, the FDA rules have been modified in light of many studies showing that mifepristone is a very safe medication. It decided not to enforce the requirement of an in-person visit, allowing the drug to be offered on prescription from certified pharmacies.
The decision in Texas by U.S. District Judge Matthew J. Kacsmaryk overturning FDA approval would have taken this drug off the market in the United States altogether. The The 5th US Circuit Court of Appeals responded quicklysaying on April 12, 2023, that the plaintiffs could not challenge the original FDA approval of mifepristone because it’s too late.
However, the 5th Circuit agreed with plaintiffs that the 2016 FDA approval of mifepristone was invalid until 10 weeks into pregnancy. In addition, based on an 1873 lawthe Comstock Act, both the Texas District Court and the Court of Appeals said mifepristone can no longer be mailed.
To make these decisions, the Texas judge and appeals court first had to determine that the groups bringing the case had been harmed by the FDA’s original approval and thus had what is referred to in legal terms as “standing” to may act. to sue. The plaintiffs include a coalition of anti-abortion physician associations that filed the lawsuit in Texas so that it would be assigned to this judgewho was an anti-abortion lawyer prior to his judicial appointment.
This case, and another involving a Washington federal judge another decision about mifepristone, are now on its way to the Supreme Court. But regardless of how that court rules, we – a lawyer And an academic obstetrician/gynecologist and specialist in complex family planning – see multiple claims about mifepristone in the decisions with potential implications for reproductive health care and legislation.
Legal history paved the way
Both decisions stem from decades of court rulings interpreting medical science for legal purposes. The 2022 Dobbs decision those nearly 50 years of the constitutional right to abortion opened the door to legal challenges for all abortions. Dobbs discussed the medical care surrounding pregnancy and childbirth, but that is what the case was mainly about reinterpretation of the legal history of abortion to justify the overturning of precedent.
While some states have further limited access to abortion in the wake of After the Dobbs decision, they failed to successfully stop the distribution of drugs that can cause abortions. In part this is because both the FDA and the Department of Justice have allowed abortion-inducing medications to be shipped from states with fewer legal restrictions.
The Texas case illustrates how judges apply their own reading of science to a thorny political issue. Kacsmaryk’s reasoning echoes Judge Anthony Kennedy’s approach in a Supreme Court case known as the Carhart decisionwhich restricted doctors from performing a second-trimester abortion procedure.
In that 2007 case, Kennedy claimed that women are psychologically harmed by an abortion. Yet scientific studies show that it is harmful to refuse an abortion and force women to give birth are larger and last longer, with higher mortality rates. The law influences public discourse, and these statements about psychological harm now do too commonplace in anti-abortion communication. These arguments were central to the Texas judge’s criticism of the FDA’s scientific process.
Assess damage
Before arguing that the FDA’s scientific fortitude was inadequate, Kacsmaryk and the 5th Circuit Court of Appeals had to decide whether the plaintiffs have legal standing. The plaintiff doctors’ first standing argument includes the statement that they are disadvantaged because they may have to care for a woman who has a extremely rare complication of mifepristone prescribed by another doctor.
Potential damage inconsistent with long-established principles related to litigation; the plaintiffs must demonstrate that the agency rule will harm them.
The status decision is based on a highly questionable interpretation of scientific evidence of harm. The 5th Circuit has been using statistics on medical abortion complications since 2000 to suggest that at least one physician in the plaintiff’s associations, which they claim number approximately 8,200 medical professionals, will see a patient seeking emergency care for using mifepristone. Yet it cites no evidence – because there is none – that only mifepristone causes complications. Further, it cites no evidence that access to mifepristone by post, or up to 10 weeks gestation, increased the rate of complications.
The 5th circuit upholding Kacsmaryk’s decision on standing claims is a narrow decision on plaintiffs’ damages. The court said these doctors are standing because complications from medical abortion are statistically likely, that the FDA has removed doctors from the process of providing mifepristone, and that providing care to women taking mifepristone is emotionally draining for the doctors.
flawed arguments
The Supreme Court has recently struggled to balance the overall impact – burdens and benefits – of various regulations, such as student debt forgiveness And immigration policy.
In this case, and using the doctors’ own harm theory, there are actually numerous benefits that the plaintiff’s doctors derive from having mifepristone available to pregnant people in Texas. Those who do not have access to mifepristone will either have to use less effective medication regimens or will be forced to have surgical abortions later in life. Delays mean the fetus continues to grow, a fact about abortion access restrictions deeply troubled Judge Kennedy.
All the risks associated with medical abortion – and thus the time and resources doctors have to devote to caring for patients – will be greater if pregnant people are forced to undergo surgical abortion or To suit.
Judge Kacsmaryk views the decision as one designed to protect women and girls, but mifepristone is a drug that offers more benefits than just safe abortion. It has been shown in numerous studies to help women safely treat an incomplete miscarriage and is now used off-label for this purpose. Studies have also shown that mifepristone is helpful in labor induction, increasing the safety of the childbirth process for someone who does go through with a pregnancy. Ongoing research into mifepristone’s other uses may be interrupted by these judges’ decisions restricting the ways the drug can be used.
Finally, it’s hard to see how the FDA approvals of other drugs aren’t fragile. For example, COVID-19 vaccines do not require an in-person doctor visit. Doctors who have vocally opposed the COVID-19 vaccine can easily find information to support arguments that they will have to care for vaccine injuries.
Doctors who oppose vaccines and other drugs might also argue that it is too emotionally draining to treat patients who need their care—thus preventing other doctors who don’t find it too emotionally draining from doing important work for people who need medical care.
The legal and medical implications make it clear just how much is at stake in these abortion-related decisions.
