by Laura Grossberndt
July 20, 2020
On July 13, a Maryland district judge granted a preliminary injunction that waives the Food and Drug Administration’s (FDA) safety limitations on administering abortion pills for the duration of the present health crisis. These limitations, part of the FDA’s drug safety program called Risk Evaluation and Mitigation Strategies (REMS), require women to visit a hospital, clinic, or medical office in person in order to obtain abortion pills. By waving these requirements, the preliminary injunction allows providers to mail abortion pills directly to women without an in-person visit. This contact-free process allegedly mitigates risks to women’s health by making them less likely to be exposed to COVID-19. However, loosening the FDA’s risk-mitigation requirements merely substitutes one health risk for another, effectively sending women out of the frying pan of COVID-19 and into the fire of severe abortion complications.
Abortion advocates have argued that the FDA’s risk mitigation requirements place a significant burden on women seeking abortions, particularly during the present health crisis. District Judge Theodore Chuang agreed, saying, “By causing certain patients to decide between forgoing or substantially delaying abortion care, or risking exposure to COVID-19 for themselves, their children, and family members, the in-person requirements present a serious burden to many abortion patients.”
Judge Chuang continued, “Particularly in light of the limited timeframe during which a medication abortion or any abortion must occur, such infringement on the right to an abortion would constitute irreparable harm.”
Such a decision fails to consider the irreparable harm that can befall women who take abortion pills. The abortion industry markets the abortion pill as straightforward and safe. However, there are over 4,000 documented cases of abortion pills endangering the lives and health of women. The pills can cause extensive physical trauma, including severe bleeding, infection, retained fetal parts, the need for emergency surgery, and even death. And that’s with the FDA’s risk mitigation requirements in place. Imagine how much more harm abortion pills could cause now that the safety restrictions on them have been temporarily waived.
There are two general types of abortion: surgical and chemical. The act of taking abortion pills is a chemical abortion. Abortion providers and activists like chemical abortions (often called by the more palliative name “medication abortion”) as an option because they require less overhead for the clinic and can be performed virtually anywhere. But this locational flexibility is precisely what makes chemical abortions so incredibly risky. While surgical abortions are performed in a clinic, chemical abortions take place at least partially at home.
Under the FDA restrictions, a woman seeking a chemical abortion would visit a physician in-person. In order to be a certified prescriber, the physician must have the ability to 1) assess the duration of pregnancy accurately; 2) diagnose ectopic pregnancies, and 3) provide surgical intervention or ensure necessary care in the event of severe complications. The woman will then take the first pill (mifepristone) in the two-part regimen. The physician would give her instructions on when to take the second pill (misoprostol). Ideally, there would be a follow-up in-person appointment to ensure the abortion was completed without any serious complications for the woman.
This process is already risky, but it at least involves a local physician in the process. Under the preliminary injunction, a woman would merely need to complete a virtual consultation in order to be mailed abortion pills. The injunction does not even specify if the prescribing physician must be local or not.
It can be difficult for the woman to know if her life or health is seriously at risk during a chemical abortion. The abortion pill’s medication guide brushes off the following types of physical trauma as normal, even a sign that the treatment is “working”:
Cramping and vaginal bleeding are expected with this treatment. Usually, these symptoms mean that the treatment is working…Bleeding or spotting can be expected for an average of 9 to 16 days and may last for up to 30 days…You may see blood clots and tissue. This is an expected part of passing the pregnancy.
In the event of severe complications from the chemical abortion, it is entirely the woman’s responsibility to get herself to a hospital. Furthermore, the cost of this emergency care is assumed by the patient, who may or may not have health care coverage.
Loosening restrictions on chemical abortions does not protect the health of women. Rather, it plays into the abortion industry’s long-term strategy of making abortions “self-managed.” Why do they want abortions to be self-managed? Because it makes abortions more commonplace and readily available—which is better for their business and bottom line. But the ready availability of abortion pills has the potential to expose women to a whole host of problems. As Patrina Mosley writes:
Making the abortion pill a “self-managed” over-the-counter (OTC) drug product has radical implications for women’s health and safety, especially as it pertains to intimate partner violence, sexual abuse and sex trafficking, and accurate patient assessment. Furthermore, it would also dangerously bypass state laws governing parental rights and informed consent on the issue of abortion.
Abortion advocates once claimed that legalizing abortion would eliminate life-threatening risks to women. Now they are attempting to make abortion completely “self-managed” despite the abortion pill’s life-threatening and health-damaging risks to women.
Judge Chuang took what ought to have been a regulatory decision (i.e., does the FDA have the authority to regulate this drug?) and turned it into constitutional privacy question based on Roe v. Wade and Planned Parenthood v. Casey. He also attempts to be a medical doctor who would know the ins and outs of what is medically necessary, instead of leaving that to the health experts—specifically, those at FDA—who wrote the regulations. Judge Chuang’s opinion sets a dangerous precedent for where the courts could go on this question in the future.
Judge Chuang made an ill-founded decision. Citing the current public health emergency as a reason for loosening the FDA’s medically justified risk-mitigation requirements for the abortion pill is not in the best interest of women’s health. Rather, it sends women out of the frying pan and into the fire.