The Food and Drug Administration approved the abortion pill in 2000. (Phil Walter/Getty Images)
A Texas federal judge with a history of anti-abortion beliefs has thrown into jeopardy the most common form of abortion since Roe v. Wade fell last summer.
U.S. District Judge Matthew J. Kacsmaryk released his decision on the cusp of Easter weekend to pause the Food and Drug Administration’s 2000 approval of the abortion drug mifepristone while a lawsuit against the agency proceeds. However, whether this ruling will ever be enforced remains to be seen. Legal experts have called into question the judge’s ability to suspend an FDA approved drug without going through agency protocol.
Doctors and abortion providers around the country told States Newsroom the decision will likely exacerbate abortion care that has already been delayed and diminished following the U.S. Supreme Court’s decision to let states regulate abortion laws.
The ruling will almost certainly be appealed to the Fifth Circuit Court of Appeals by the U.S. government, but the order is scheduled to go into effect by April 14.
“Any delay in abortion care is unnecessary and cruel, and it’s a dangerous precedent to deny access to a safe medication that science tells us is safe,” said Dr. Mollie Nisen, a family physician and abortion provider in Washington state.
Nearly simultaneously on Friday afternoon, a Washington District Court judge issued a contradictory ruling preventing the FDA from taking adverse action on mifepristone. That ruling affects the plaintiff states who brought the case, which includes 18 Democratic-led states, while the Texas case has nationwide implications. It remained unclear how the two rulings might be resolved on Friday.
As of 2020, use of mifepristone in conjunction with the drug misoprostol accounted for more than half of abortions nationwide. But in the eight months since Roe v. Wade was overturned and the FDA loosened certain regulations, the prevalence of medication abortion regimen has expanded, especially for women living in one of the 13 states that currently fully or mostly ban abortion.
Nisen said about half of her patients seeking abortion use the mifepristone and misoprostol combination rather than a surgical procedure. She also knows of patients who have managed their own abortion care at home after obtaining the drugs by mail. Like abortion providers in so-called abortion-haven states, Nisen sees patients from everywhere and is bracing for a surge in new patients following this ruling. On a recent workday, she saw patients for medication abortion from seven different states.
“People coming from as far as a seven-hour plane ride to get a five-minute procedure is what we’re looking at right now,” Nisen said.
People seek medication abortion over surgical procedures for different reasons, including cost and allergic reactions to anesthesia. But for many, it’s the only accessible abortion method, given how abortion clinics are now scattered across the country and separated by vast distances, and many of them don’t offer the surgical procedure. Until now many people have been able to avoid traveling significant distances and other delays that lead to later abortions by taking advantage of the telehealth option allowed in some states.
Additionally, doctors worry this ruling could have serious health consequences for women experiencing miscarriage, which can be life-threatening. Already providers around the country have reported that their state’s restrictive abortion laws have forced them to turn away pregnant patients even if they’re experiencing, or at risk for, serious health complications.
Ruling has implications for miscarriage management, doctor says
In a “friend of the court” brief filed in the lawsuit in February, leading medical and public health societies that include the American College of Obstetricians and Gynecologists, the Society for Maternal-Fetal Medicine, and the American Medical Association wrote: “Recent research has shown that prescribed mifepristone, in conjunction with misoprostol, improves safety outcomes for patients experiencing pregnancy loss.”
Mifepristone blocks the hormone progesterone, which a pregnancy needs to progress. It’s followed by the drug misoprostol, which has other indications but also causes the uterus to expel the embryo or fetus. The FDA has recommended it be used up to 10 weeks in pregnancy; the World Health Organization says 12.
Dr. Loren Colson, a primary care physician in Idaho who is also a fellow with national advocacy group Physicians for Reproductive Health, is among those concerned for his miscarrying patients. Idaho has a near-complete ban on abortions at any stage of pregnancy. Doctors who provide abortions must prove they were trying to save the pregnant person’s life. (Similarly, survivors of rape and incest who want an abortion have to first file a police report.)
Colson said he has seen many patients at his clinic seeking care for miscarriages since the ban went into effect, and while the clinic has had difficulties securing mifepristone, the doctors have been able to use it to help those patients.
When a pregnant person miscarries, which happens in as many as 26% of all pregnancies, the pregnancy often does not completely end for weeks if not months, Colson said. According to his estimates, about 80% of patients’ pregnancies will resolve within one month, while the remaining 20% could take six weeks or longer. Mifepristone and misoprostol taken in combination after an early miscarriage has a success rate of completing miscarriages by day two in 84% of Colson’s patients, according to his data.
Misoprostol alone – which is what many doctors currently prescribe for an early miscarriage, depending on the situation – will still be faster for some patients than using no drugs at all, Colson said, but by itself, the number of prescribed doses would increase, which creates more cramping and other side effects. The ruling bothers him because the medicine now pulled from shelves has fewer side effects than misoprostol and creates a better outcome for patient comfort.
“(Mifepristone is) an incredibly safe medication, and there’s no real reason to get rid of it except to inhibit access to a standard of care,” Colson said. “And for folks that are advocates of banning abortion, that means not getting the standard of care for an abortion, but the unintended consequence is for miscarriage management as well.”
Adapting to new challenges
Abortion-rights advocates and providers have been preparing for this legal outcome since plaintiffs sued the FDA last November. Some advocates have been forming an underground network of abortion pills and helping people access the medication outside of the U.S. legal system.
Some abortion clinics have already promised to keep offering medication abortion, regardless of Kacsmaryk’s ruling.
Some doctors plan to recommend misoprostol alone for patients who want or can only access abortion via medication – something OB-GYNs sometimes did before the FDA approved mifepristone in 2000.
Dr. Deborah Nucatola, chief medical officer for Planned Parenthood Great Northwest Hawaii, Alaska, Indiana and Kentucky, has practiced abortion care in nine states for more than 25 years, which includes a stretch of about five years before mifepristone. When the drug was introduced, effectiveness and speed to complete an abortion rapidly increased, she told States Newsroom.
“Losing access means patients still have access to options, but it takes longer, and the risk of failure is higher,” she said.
Nucatola expects more patients will have incomplete abortions and will need to return for the surgical procedure, called aspiration, which involves using suction to empty whatever tissue remains in the uterus.
Time is the most important factor when it comes to optimizing women’s recovery from spontaneous or induced abortion, Nucatola said. Medication abortion works quickly, and has a low infection rate. She expects infection rates will remain low with misoprostol-only, but the longer it takes for a pregnancy to fully end, the higher the chances of infection and other complications.
Misoprostol is still a safe and effective medication, she said, but the higher doses cause more side effects, such as chills, nausea, vomiting, gastrointestinal distress and fever. The recommendation is 12 misoprostol pills, as opposed to four for medication abortions before eight weeks.
“(Patients are) just going to have a lot more discomfort for longer,” Nucatola said, underscoring that providers will continue to support patients amid the coming challenges. “We trust our patients to do the best thing for themselves, and we’re going to do everything we can to support them, whether or not we have access to mifepristone.”
But for anti-abortion lobbying groups, today is a huge victory, years in the making.
Students for Life of America (SFLA) – a national group that fights against abortion and birth control access on college campuses – has for years campaigned against mifepristone and against the FDA’s loosening of restrictions, which most recently included allowing retail pharmacies to dispense the medication abortion regimen directly to patients.
SFLA president Kristan Hawkins said on a recent webcast. “When I launched Students for Life more than 16 years ago, we knew we were going to need a trained army, ground troops ready to go in states and communities around the country the moment Roe versus Wade was reversed. And we began looking at this issue of chemical abortion five years ago.
Like the plaintiff anti-abortion medical groups in this lawsuit, Students for Life uses the number 28 to argue that mifepristone should be banned. It’s the same number the FDA uses to argue that it’s safe: 28 deaths out of an estimated 5.6 million people in 23 years have been associated with the FDA’s abortion regimen, which is a markedly lower rate than many common FDA-approved drugs, like Tylenol and Viagra. And as the FDA notes, that small number includes fatal cases “regardless of causal attribution to mifepristone,” including people who died from homicide, suicide, and pulmonary emphysema.
But Hawkins did acknowledge that the procedure her movement is trying to ban terminates pregnancies early, in the first trimester – which is something most Americans favor, in public opinion polls.
“We became very concerned that there were legislative advances to make chemical abortion pills the preeminent type of abortion that’s offered in our country,” Hawkins said. “Because the abortion industry reads the same polls that we read. They know that the majority of Americans oppose second- and third-trimester abortions.”
A recent Public Religion Research Institute poll contradicts Hawkins, finding that 52% of Americans oppose restrictions that make it illegal to obtain an abortion after 15 weeks of pregnancy.
Asked via email if SFLA expects an increase in second- and third-trimester abortions if this ruling makes first-trimester abortions harder to access and what the impacts of banning abortion drugs will be, Hamrick said, “Lives will be saved.”
Many doctors across the country disagree with her.
“Making mifepristone unavailable nationwide — even in states where abortion remains legal — will impose a severe, almost unimaginable cost on pregnant people throughout the United States,” write the American College of Obstetricians and Gynecologists and the other medical and public health societies in its brief.
“Medication abortion’s relative availability makes it more accessible to patients who otherwise face challenges to access medical care, including low-income patients and patients of color—the very people who are most likely to experience severe maternal morbidity and more likely to die from pregnancy-related complications.”
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