The U.S. Supreme Court has agreed in December to hear another abortion case, this one focused on medication-induced abortion, which accounts for more than 50% of all abortions in the United States.
Mifepristone is a commonly accessible and commonly-used abortion pill prescribed by health care professionals. The Food and Drug Administration (FDA) first approved the drug in 2000.
The Human Coalition, an anti-abortion group, filed an amicus brief with the Supreme Court arguing that the drug is unsafe.
“Politics should never trump the lives of women,” the brief argues. “But the FDA allowed just that to happen when it deregulated the dangerous pregnancy-ending drug mifepristone.”
The American College of Obstetricians and Gynecologists (ACOG) filed an opposing amicus brief, arguing that mifepristone is safe and effective.
The FDA based its initial approval on robust evidence which showed mifepristone was extremely safe, [and] the evidence collected and studies performed since that decision in 2000 have only served to confirm this.
— Brief filed by the American College of Obstetricians and Gynecologists
“This is not an opinion—it is a fact based on hundreds of medical studies and vast amounts of data amassed over the course of two decades,” ACOG argued in their brief. “The FDA based its initial approval on robust evidence which showed mifepristone was extremely safe, [and] the evidence collected and studies performed since that decision in 2000 have only served to confirm this.”
“Serious side effects occur in less than 1% of patients, and major adverse events— significant infection, blood loss, or hospitalization—occur in less than 0.3% of patients,” the brief continues. “The risk of death is almost non-existent.
Dr. Emily Freeman, an obstetrician gynecologist in Cleveland, also insists that mifepristone is safe.
“Mifepristone is a medication that is a part of a safe, effective FDA-approved drug regimen for medication abortion,” she said.
Freeman’s subspecialty of complex family planning (CFP) is focused on complex contraception, abortion care and early pregnancy loss.
She adds that the side effects of mifepristone are minimal and common among a lot of other prescribed drugs.
“Mifepristone alone actually has very little side effects. Some common side effects of medication abortion process include bleeding and cramping, which are expected,” she said. “Some other possible side effects include nausea, vomiting and diarrhea. Some people can get a fever for a short time or chills.”
Mifepristone, commonly marketed as Mifeprex® (200mg) and Korlym™, works to block the hormones necessary for pregnancy.
“Mifepristone blocks progesterone,” Freeman said. “Without progesterone, the lining of the uterus breaks down and the pregnancy cannot continue.”
Doctors prescribe it in conjunction with Misoprostol, which contracts the fetus from the uterus.
The two drugs work together to end a pregnancy no further than ten weeks in gestation.
The case against mifepristone was brought by the Alliance for Hippocratic Medicine, a Texas doctors’ group, who sued the U.S. Food and Drug Administration in Federal District Court last year, arguing that the drug is not safe.
Federal District Judge Matthew Kacsmaryk, appointed by Donald Trump in 2017, agreed, suspending the FDA’s approval of the drug after more than 20 years of availability.
Immediately thereafter, Thomas O. Rice, another federal district judge in Washington state issued an order not to block access to the drug in at least 17 states.
With conflicting rulings in place, the 5th Circuit Court of Appeals put part of Kacsmaryk’s ruling on hold, and the Biden Administration asked the Supreme Court to protect access to the drug.
The Supreme Court put the lower court rulings on hold in April, and agreed in December to hear the case. They will likely issue a decision by this summer.
Mifepristone has uses beyond terminating pregnancy. It also works to treat Cushing’s syndrome, a very common syndrome with about 3 million cases per year, in which the body contains too much cortisol.
If left untreated, Cushing syndrome can cause high blood pressure, bone loss, and type two diabetes. Mifepristone works as a cortisol receptor blocker to treat Cushing’s syndrome.
Although the Supreme Court has not yet heard the case, many have concerns that the court will restrict access to mifepristone, given the majority of the court’s pro-life majority and June 2022 ruling in Dobbs v. Jackson Women’s Health Organization, which overturned Roe v. Wade.
Some people want to restrict patients’ access to this medication as a way to restrict people’s access to safe abortion care. However, the implications of restricting mifepristone have much larger consequences because it would impact its use for miscarriage.
— Dr. Emily Freeman, OB/GYN
Dr. Freeman explained that the FDA already restricts mifepristone through Risk Evaluation and Mitigation Strategies (REMS).
“[These] restrictions on mifepristone are not supported by research and create medically unnecessary barriers for patients accessing both medication abortion and the best method of managing a miscarriage,” Freeman said.
Additionally, Ohio’s further restrictions on medication abortions have already greatly affected her field.
There are numerous Ohio laws that further restrict the prescription and administration of medication abortion.
“In Ohio, a patient who wants a medication abortion (either for abortion or miscarriage) has to come into the office or clinic for me to give them the medication and I can not send it to the pharmacy for it to be dispensed there,” Freeman said.
She made it clear just how difficult a heavier restriction would be for her field.
“It would also prevent us from using mifepristone for the treatment of early pregnancy loss, which is the most evidence-based method for medically managing miscarriage,” she said. “Some people want to restrict patients’ access to this medication as a way to restrict people’s access to safe abortion care. However, the implications of restricting mifepristone have much larger consequences because it would impact its use for miscarriage.”
