- The U.S. Supreme Court announced on Wednesday it would review a challenge by a lower court to restrict access to the abortion pill mifepristone nationwide.
- In August, a U.S. appeals court ruled to impose restrictions on mifepristone, challenging the safety of the evidence-based drug.
- The appeals court claims the FDA’s approval process for mifepristone is inadequate.
- Access to mifepristone remains unchanged until the court decides, likely in the summer of 2024.
The U.S. Supreme Court announced on Wednesday it would review a lower court decision that would restrict access to the abortion pill mifepristone nationwide — even in states where abortion is legal.
The announcement follows an August 16 ruling by the U.S. Court of Appeals for the 5th Circuit that challenged the safety of mifepristone.
The court’s move challenges the Food and Drug Administration’s authority over mifepristone, an evidence-based, safe treatment for medical abortion. The drug has been extensively reviewed, studied, and evaluated for
Restricting access to mifepristone would lead to bans on prescriptions via telemedicine and blocked shipments of the medication by mail, creating additional barriers in states where abortions are now illegal or highly restricted since Roe v. Wade was overturned last year.
But a mifepristone ban will not immediately take effect until the Supreme Court hears the case during the current term and makes a decision, likely by summer 2024, NPR reports.
“The most important thing to know about this ruling is that it does not change anything right now,” Dr. Sarah W. Prager, a professor in the Department of Obstetrics and Gynecology at the University of Washington School of Medicine, told Healthline in August.
“If, ultimately, mifepristone is disallowed from being prescribed normally or mailed, it will have significant negative impacts on the ability for people to access abortion.”
Mifepristone was approved by the
The oral pill is a synthetic steroid that blocks the pregnancy hormone progesterone.
When used in conjunction with misoprostol, mifepristone is considered a safe and effective way to end a pregnancy through 10 weeks gestation.
While some anti-abortion activists have claimed that adverse effects associated with mifepristone have led to hospitalizations, the overall mortality rate associated with medical abortions is incredibly low.
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In the study, 28 deaths were reported in these cases, but that included all deaths after people took the drug, including deaths related to homicide and drug intoxication. At least 10 of the 28 deaths were linked to homicide, suicide, or drug intoxication.
“Mifepristone is incredibly safe and effective as part of the standard regimen for medication abortion,” Prager said.
“We have several decades of data from dozens, if not hundreds, of studies, including thousands of pregnant people demonstrating the safety and efficacy of mifepristone and misoprostol for use in medication abortion.”
The New Orleans-based 5th Circuit’s ruling upholds an April 2023 decision by a Texas federal judge invalidating the FDA’s approval of mifepristone. Judge Matthew J. Kacsmaryk was appointed by former President Trump.
The three-judge panel’s 93-page ruling followed a 2022 lawsuit filed by the anti-abortion group The Alliance of Hippocratic Medicine, which aimed to remove mifepristone from the market entirely.
The ruling claims that the “FDA overlooked important safety risks in approving mifepristone and amending its restrictions… Medical Organizations and Doctors contend that FDA overlooked important safety risks in approving mifepristone and amending its restrictions. They assert that FDA’s actions were unlawful under the Administrative Procedure Act,” the 5th Circuit judges wrote.
The anti-abortion group Alliance Defending Freedom, which has been outspoken about its opinion on the FDA’s approval of mifepristone, praised the 5th Circuit in August.
“The 5th Circuit rightly required the FDA to do its job and restore crucial safeguards for women and girls, including ending illegal mail-order abortions.,” the group said in a release.
“This is a significant victory for the doctors and medical associations we represent and, more importantly, the health and safety of women.”
While the 5th Circuit ruling would override the authority of the FDA, it does not affect the FDA’s approval of mifepristone or the generic version of the drug.
Mifepristone’s availability remains unchanged until the Supreme Court decides on the case this summer.
If the 6–3 Conservative majority rules to restrict access to the medication, Prager explained that complications could arise for people seeking alternative ways to induce medical abortion.
“Misoprostol alone can also be used effectively for medication abortion, though typically more doses will be required, and the efficacy is not quite as good,” Prager said.
“Additionally, without mifepristone, people typically have more side effects. The real significance of making mifepristone unavailable is to make a medication abortion less effective, more painful, less predictable, and harder for pregnant people,” she added.
If medication abortion is no longer available by telehealth prescription or mail order, more people may have to receive procedure abortions, which will “clog up clinics and push gestational ages higher,” Prager said.
Others may not be able to “access abortion at all and be forced to continue pregnancies that are unwanted and/or dangerous to their health,” she noted.
Dr. Jamila Perritt, an OB-GYN in Washington, D.C., and president and CEO of Physicians for Reproductive Health, told Healthline the Supreme Court has an opportunity to rule in favor of scientific evidence and center the needs of our communities.
“Many people will need abortion care over their lifetimes, and today, the majority of abortions accessed are done using medication abortion,” Perritt said.
“Mifepristone is a safe and effective medication. There is no legitimate medical or scientific reason access to mifepristone should be limited. It is clear this case is about anti-abortion extremists’ desire to ban all abortion care in this country.”
Monica Cepak, interim CEO of Wisp, a group of sexual and reproductive healthcare professionals, told Healthline the court’s latest announcement is a step in the wrong direction for the future of reproductive healthcare.
“Reproductive healthcare is healthcare,” Cepak said. “Medication abortion [is] an important aspect of reproductive health. This is just another unfortunate example of the courts having unsolicited power over a woman’s body. We hope to see a day when autonomy over our bodies is no longer ruled by third-party votes.”
The U.S. Supreme Court decided on Wednesday it would review a challenge by a lower court to restrict access to the abortion pill mifepristone nationwide.
The availability of mifepristone remains unchanged until the court makes a decision, likely in the summer.
If the court upholds the 5th Circuit ruling, mifepristone would no longer be available via telehealth prescription or mail in states where abortion is banned or restricted.
“People who do not want to be pregnant will go to great lengths to achieve that, and closing off safe and effective means of achieving an abortion makes things more dangerous for pregnant people,” Prager said.
“The outcome of any and all restrictions to abortion is to make pregnancy less safe and to create a situation that worsens health for pregnant people.”