Updated on December 13, 2023.
The U.S. Supreme Court has agreed to take up the Biden administration's bid to maintain access to the widely used abortion pill mifepristone. In response to the Supreme Court's decision to hear the case, White House press secretary Karine Jean Pierre said the Biden administration will continue to stand behind the FDA's approval of mifepristone as safe and effective.
"No woman should be unable to access the health care that she needs," she said in a statement. "This should not happen in America, period."
Why access to the abortion pill is threatened
In November 2022, an anti-abortion group called the Alliance for Hippocratic Medicine initiated a lawsuit, arguing the FDA’s approval of mifepristone 23 years ago was rushed and violated federal standards. This came less than one year since many states effectively banned abortion in the wake of the June 2022 reversal of Roe v. Wade— the landmark ruling that made access to an abortion a federal right for Americans.
On April 7, 2022, a federal district court in Texas issued a decision, which blocked the long-standing approval of the drug. In response, the U.S. Department of Justice immediately appealed the decision.
The New Orleans-based Fifth U.S. Circuit Court of Appeals ruled the FDA’s approval of mifepristone could remain in effect, but imposed restrictions on how the pill may be accessed and when it may be taken.
In 2016, the FDA eased rules, extending the drug’s use from seven to 10 weeks of pregnancy. The FDA also allowed the pill to be dispensed by mail, without the need for an office visit. Although the appellate court ruling allowed the drug to remain available for the time being, the 2016 adjustments were rolled back, greatly limiting its access.
The ruling, however, has not taken effect due to an emergency order from the U.S. Supreme Court, following an emergency application filed by the Biden administration.
The Supreme Court paused the lower court ruling, preserving the widespread availability of the abortion pill without restrictions while the Biden administration’s appeal proceeds. Five of the nine justices agreed to grant the stay. Justices Clarence Thomas and Samuel Alito publicly dissented. It's unclear how other justices voted.
The decision by the U.S appeals court will not take effect until the Supreme Court reviews it. A decision is expected in June 2024.
What is a medical abortion?
A medical abortion uses medication—not surgery or a procedure—to end an early pregnancy. Commonly known as the “abortion pill,” the drug mifepristone is given along with another medication called misoprostol.
Unlike Plan B (the “morning-after pill”), which may be used to block fertilization or prevent a fertilized egg from implanting in the uterus, mifepristone works by blocking the hormone progesterone. This causes the lining of the uterus to break down, which ends a pregnancy. The second drug, misoprostol, is taken up to 48 hours later. It causes the uterus to empty its content like a heavy, crampy period.
Those who take the pills must follow up with their healthcare provider roughly seven to 14 days later to confirm the uterus is empty to avoid infection.
New restrictions would block access to the drug
Mifepristone may be given along with misoprostol to end a pregnancy up to 10 weeks gestation (49 days or less since the first day of a person’s last menstrual period).
Rolling back the use of the drug to just seven weeks gestation would have significant implications as many people do not realize they are pregnant by this point. A March 2022 study published in Contraception found that one in five people discover their pregnancy past seven weeks. The researchers noted that, in most cases, people who suspect they are pregnant take an at-home pregnancy test. Those that do find out that they are pregnant about one week earlier than those who go to a clinic, the study showed.
But young people, those who have never been pregnant before, and those with unplanned pregnancies were less likely to use these tests as a first step. Young people, in particular, reported issues accessing at-home pregnancy tests, including not being able to get to a store or not having enough money to buy one.
People of color, people living with food insecurity, and people with unplanned pregnancies were also more likely to learn that they are pregnant past seven weeks.
Those with irregular menstrual periods are also less likely to know they are pregnant by seven weeks gestation because they cannot reliably determine when to expect their next period. A November 2021 study published in Proceedings of the National Academy of Sciences (PNAS), involving more than 267,000 people, found that 22 percent experienced irregular periods. Those more likely to be affected were younger people aged 18 to 24, as well as those with polycystic ovary syndrome (PCOS), type 2 diabetes, and certain hormone disorders. People who gave birth within the past year, Hispanic and non-Hispanic Black people were also more likely to experience irregular menstrual cycles.
During the COVID pandemic, the FDA announced that health care providers could become certified to prescribe mifepristone by completing a Prescriber Agreement Form. Before the drug regimen could be prescribed, however, patients and their healthcare provider must review and sign a Patient Agreement Form, acknowledging that the risks of the treatment regimen have been explained and are understood. Similarly, pharmacies must also be certified to dispense the drugs by completing a Pharmacy Agreement Form.
At that time, the FDA allowed the pills to be sent through the mail following telehealth appointments. On January 3, the in-person doctor’s visit requirement to access a medical abortion were removed. Under the appellate court ruling, which has been temporarily paused by the Supreme Court, three visits would be required.
But is it effective—and safe?
The abortion pill is not new. The FDA first approved Mifeprex in 2000 and approved a generic version of the drugs in 2019. In 2020, medical abortion was used in 54 percent of all abortions in the United States, according to the Guttmacher Institute, a nonprofit focused on sexual and reproductive health and rights.
Surgical abortions may be quicker, result in less bleeding, and more immediately ensure that all fetal tissue is removed from the uterus, reducing the risk for infection. But some people may prefer to avoid an invasive surgical procedure and anesthesia. Risks of surgery also include possible vaginal or cervical lacerations, as well as injury to the uterus, bowel, or bladder. Taking medications in private at home may also offer a greater sense of control and comfort.
The Texas lawsuit now headed to the Supreme Court alleges that the FDA’s initial approval of mifepristone did not adequately review its safety risks. This comes despite multiple decisions and scientific reviews by regulators over the past 23 years. Since it was approved in 2000, mifepristone has been used by more than 5.6 million people, the FDA points out.
Medical abortions are highly effective, working between 95 and 99 percent of the time. A meta-analysis of 87 clinical trials also shows that medical abortion is safe. The review, which included more than 45,000 people, found that serious complications requiring hospitalization occurred in less than 0.3 percent of patients.
A 2019 analysis of FDA data conducted by the University of San Francisco Medical Center also found only 13 deaths possibly or probably related to medical abortion—a mortality rate of roughly 0.00035 percent.
Mifepristone is also used for the medical management of missed miscarriages—when the body doesn’t recognize the death of a fetus. It some cases, those who’ve experienced such a miscarriage may choose to avoid a dilation and curettage (D&C), a procedure that can be performed to remove tissue from inside the uterus and prevent infection.
It may also be used to manage endometriosis or Cushing syndrome, which occurs when the body’s levels of the hormone cortisol are too high over time.
The FDA cautions, however, that purchasing mifepristone online or outside the United States from a provider or pharmacy that is not certified is risky, noting that it does not have oversight of prescription medicines outside the U.S. drug supply chain.
Some people should not take the abortion pill. It may be dangerous for those who:
- Are more than 11 weeks pregnant
- Have an ectopic pregnancy (a pregnancy outside of the uterus)
- Have an adrenal gland condition
- Are undergoing long-term corticosteroid therapy
- Have had an allergic reaction to mifepristone, misoprostol or similar drugs
- Have bleeding problems or are taking medications to thin the blood
- Have a rare disorder called inherited porphyria
- Have an intrauterine device (IUD) in place
Within the first 24 hours of taking mifepristone and misoprostol, side effects may include nausea, cramping, spotting, headache, diarrhea, and dizziness. Symptoms that are more severe or do not resolve within 24 hours could be a sign of a more serious health concern. Complications are rare but may include severe bleeding and infection.
Those who experience the following symptoms after taking mifepristone and misoprostol should seek immediate medical attention:
- Heavy bleeding (enough to soak through two thick, full-size sanitary pads per hour for two consecutive hours)
- Abdominal pain or discomfort
- Fever of 100.4°F or higher that lasts for more than 4 hours
- Feeling sick, including weakness, nausea, vomiting, or diarrhea, with or without fever
These symptoms may be a sign of a serious infection or another problem, such as an ectopic pregnancy. If you are experiencing these warning signs and cannot immediately reach your healthcare provider, go to the nearest hospital emergency room.
