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Abortion pills: What's going on?
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On Friday, two federal judges in Washington and Texas handed down opposing rulings regarding abortion pills. How this plays out could have a huge impact on public health.
I partnered with Dr. Heidi Moseson, a reproductive epidemiologist, and Professors Rachel Rebouche and David Cohen, reproductive health scholars, to translate what’s going on, the public health science in one case (and lack thereof in the other), and what it means for people today.
What’s going on?
Medication abortions use a combination of two drugs: mifepristone (let’s call this “mife”) followed by misoprostol (let’s call this “miso”).
One in two abortions (~490,000) in the U.S. are medication abortions, and this proportion has steadily increased over the years. One reason is that medication abortions can be accessed remotely via mail—salient for the nearly 60% of Americans who now live in a state with limited access to abortion clinics.
Mife and/or miso are also used as a first line of treatment in other life-saving events like miscarriage management, labor induction, and prevention of postpartum hemorrhage.
Last Friday, two opposing legal cases were ruled on medication abortion in the U.S.
Case #1: Texas
Last November, a group filed a lawsuit with the goal of overturning the FDA’s decades-old approval of mife.
Their lawsuit put forward three claims:
The FDA improperly used its authority to approve mife in 2000. The FDA approved mife under a certain part of the law which says new drugs are approved for “treating serious or life-threatening illnesses.” The legal group argued that pregnancy is not an illness and, therefore, the FDA cannot approve mife.
Mife is not safe. Some studies show that medication abortions with mife have a slightly higher complication rate than procedural abortion, thus the FDA acted improperly when it modified its regulation of mife in 2016, 2019, and 2021.
Mailing abortion pills is illegal. A 150-year-old law (the Comstock Act) bans mailing materials intended for producing abortion, in this case mife for abortion. This law historically only applies for materials that the sender knows would be used for “unlawful” abortions, which is an intent difficult to prove.
The Texas judge could have ruled a gazillion ways: ruled on one of these claims, all of these claims, or anything in between.
Ultimately, the judge “stayed the FDA’s approval”—temporarily put the approval of mife on hold. Suspension of the FDA’s approval would apply to all states (not just in Texas). However, in doing so, he was going to wait for seven days, giving parties time to appeal. What happens on day 8? It’s not clear and may depend on the eye of the beholder (see more below). Regardless, this is unprecedented, as it’s the first time that a court suspended an FDA approval.
As expected, the Justice Department appealed, asking the 5th Circuit Court of Appeals to hold off on the judge’s order until an appeals decision is reached.
Case #2: Washington
In March 2023, 17 states and DC filed a case in Washington state to force the FDA to drop restrictions on mife. This was essentially the exact opposite of the case in Texas.
Their lawsuit put forward two claims:
Mife is safe and effective. The FDA followed all appropriate protocols in its initial approval of mife. Mife’s safety profile is unassailable, and removing this drug from the market would cause “immediate and irreparable injury.”
FDA-imposed restrictions on mife’s use are burdensome and unnecessary. In January 2023, the FDA added a certification requirement for any pharmacy hoping to distribute mife, and kept in place other burdensome forms. These requirements make mife harder to access for patients and are unnecessary.
The Washington judge did not rule on mife restrictions, but instead the judge ordered the FDA not to take any action to change the current situation in which mife is approved. This ruling applies only to the 17 states and DC named in the suit, not nationally.
The public health science (or lack thereof)
One of the questions posed by case #1 —“Is pregnancy an illness?” — is a question asked and answered before. So much so that the scientific evidence has been reviewed, and reviewed, and reviewed again:
2000: FDA conducts in-depth review
2008: review by the Government Accountability Office
2018: review by the Government Accountability Office
All confirmed that the FDA followed its standard practice when it approved the medication.
The question posed in Case #2 — “Is mife is safe and effective?” — is answered by the 23-year track record of mife’s use in the U.S. and safety data documented in more than 100 peer-reviewed articles. As YLE has written before, the scientific evidence resoundingly establishes that medication abortion is safe and effective. Major complications (those requiring hospitalization, surgery, or blood transfusion) following use of mife are extremely rare, occurring in 0.3% of cases. (As a comparison, 1.4-2.3% of women have major complications after childbirth.)
What does this mean today?
Today, people can still get mife and miso for abortion.
Will this change in the future? It’s unclear.
The ball is now in the hands of appellate courts within the U.S. Justice system. The case will likely go to the Supreme Court.
In the meantime, it’s unclear how the FDA and the drug manufacturers will respond, given that the FDA is under contradictory rulings.
The FDA could use “enforcement discretion”—elect not to enforce the Texas ruling for the medications within its purview. This is not the same thing as ignoring the court, but is a long-recognized power of the FDA that the Supreme Court approved of in 1985. They can do this with mifepristone because the Texas judge did not order the FDA to take any particular action—the judge is saying the approval was never valid in the first place. There’s nothing for the FDA to “do.”
Medical choices for pregnancy care are being tested. This is the first time a judge has stayed approval of a drug over the objection of the FDA and the drug manufacturer—a precedent that could upend our medication ecosystem beyond abortion. Regardless, confusion alone can be a strong deterrent to care, as we saw throughout the pandemic.
We should all be closely watching how the appeals play out and how the FDA responds.
Love, YLE, HM, RR, DC
In case you missed previous posts:
Heidi Moseson, PhD, is a reproductive epidemiologist and scientist at Ibis Reproductive Health. She studies abortion access in the U.S. with a particular focus on self-managed abortion with medications.
Rachel Rebouche is a reproductive health scholar and Professor of Law at Temple University.
David S. Cohen is a reproductive rights scholar and Professor of Law at Drexel University.
“Your Local Epidemiologist (YLE)” is written by Dr. Katelyn Jetelina, MPH PhD—an epidemiologist, data scientist, wife, and mom of two little girls. During the day she works at a nonpartisan health policy think tank and is a senior scientific consultant to a number of organizations, including the CDC. At night she writes this newsletter. Her main goal is to “translate” the ever-evolving public health science so that people will be well equipped to make evidence-based decisions. This newsletter is free thanks to the generous support of fellow YLE community members. To support this effort, subscribe below: