In June, the U.S. Supreme Court is expected to decide the fate of the abortion medication mifepristone — a decision that could undermine access to the medication at a time when major pharmacies and retailers have begun to offer the pill.
Abortion rights advocates, reproductive health clinicians, and others are bracing for a decision that could upend access to safe, legal self-managed abortions for most or all women in the nation.
There need to be at least two justices willing to join with the liberals on maintaining access to mifepristone. But the stakes are high with the precedent of a 6-3 Supreme Court decision to overturn Roe v. Wade on June 24, 2022, with the Dobbs v. Jackson Women’s Health Organization ruling.
Without some help from conservative justices, mifepristone may be taken off the shelves. It also is possible that a majority of justices will decide that the Food and Drug Administration (FDA) should end telemedicine prescriptions for mifepristone but allow for it to be administered at in-person clinics.
It is unclear if a court decision that restricts mifepristone’s access would affect the availability of the drug at local pharmacies. In March 2024, CVS and Walgreens officials announced they had received certification to dispense mifepristone under 2023 FDA guidelines and would sell the medication in some stores.1 These decisions may improve access to the safest and most effective medication abortion method, which accounts for 63% of abortions in the United States.2
Concerns about mifepristone’s safety, as alleged in the lawsuit that led to a lower court decision to take mifepristone off the shelves, are unfounded, according to research — including a new study on telehealth with mifepristone.3
“We found that safety of telehealth abortion care and effectiveness of telehealthcare were equivalent to safety and effectiveness rates when the medication is dispensed in person,” says Ushma Upadhyay, PhD, MPH, an associate professor in residence at the University of California, San Francisco. There is no reason to rescind the FDA approval of mifepristone, and the court decisions against the drug’s legalization were wrong, she says.
Most research has found mifepristone to be safe and effective. A handful of studies suggesting health problems from the medication were retracted due to serious problems with their data and unreported conflicts of interest. Those included studies that had been used in the Texas lawsuit against mifepristone’s FDA approval. (See more about the Texas lawsuit over mifepristone access in April 2023 and April 2024 issues of Contraceptive Technology Update.)
Upadhyay and colleagues studied the safety of the drug when administered via telehealth from three virtual clinics. They found that among 6,034 abortions, 97.7% were complete without a known intervention or ongoing pregnancy after the first treatment. In all, 99.8% of the abortions had no serious adverse events. The fraction of people with a serious event included 0.16% who had an ectopic pregnancy. About one out of 100 people had an emergency room visit, including those without a serious adverse event.3
The effect of rolling back the drug’s approval would be devastating for all people capable of pregnancy across the United States, Upadhyay says. It also could push abortion clinics well past their capacity as demand for in-person abortions would skyrocket. Telehealth abortion has helped abortion providers address surges in demand in states where telehealth abortion remains legal. “Telehealth is under REMS [Risk Evaluation and Mitigation Strategies], so distribution is governed by the FDA,” she explains.
Through REMS, the FDA requires prescribers and dispensers to be certified in the REMS and to agree to carry out activities designed to mitigate the drug’s risk. Reproductive health advocates have long claimed that REMS should not apply to mifepristone because it is safer than aspirin.
The FDA removed the in-person dispensing requirement on mifepristone in 2021, following studies that showed positive outcomes with telehealth medication abortion. After that change, virtual clinics could conduct real-time videoconferences with patients or provide asynchronous communication using secure text messaging. Both methods worked well, particularly in states that did not ban abortion.3
If the court partially rolls back the FDA’s decisions and allows the drug to remain on the shelves but under the same rules as when it was first approved in 2000, it would be damaging for millions of people who live in abortion-ban states. A partial rollback would end telehealth abortions, even in states supportive of abortion rights, Upadhyay adds.
Many have relied on self-managed medication abortions, obtaining the drugs through telehealth, since this option became available during the pandemic. (For more information, see the story in this issue on the safety of telehealth abortions.)
More than half of all abortions use mifepristone, Upadhyay notes. “Today, telehealth accounts for 16% of all abortions in the U.S., and that includes shield law abortions as well,” she says. “Telehealth has made a huge impact in terms of keeping in-person equipment times open for people traveling in from other states and who may need later abortion care and not qualify for medication abortion.”
Telehealth has opened access to abortion care in states where clinics have closed. It also has allowed providers and clinicians in one of the six states with shield laws to send abortion pills to people in abortion-ban states. “Doctors, nurse practitioners, and midwives are mailing them to people in abortion-ban states,” Upadhyay says.
The six states with state laws that protect providers who offer abortion care from civil lawsuits and criminal charges by authorities in abortion-ban states are New York, Colorado, Washington, Massachusetts, Vermont, and California.
Without telehealth mifepristone, many people who desire an abortion would end up obtaining it later in pregnancy. They would have to travel and raise funds to cover the exorbitant costs, and some would have to take 12-hour road trips to receive abortion services, Upadhyay says. “All of that would lead to people obtaining an abortion later in pregnancy,” she adds.
More than 700 pharmaceutical, biotech, and investment business leaders have condemned the April 7, 2023, decision to overturn the FDA’s 2000 approval of mifepristone. They wrote a one-page letter in April 2023, stating that District Judge Matthew Kacsmaryk’s decision undermined the bipartisan authority that Congress granted to the FDA and his decision constituted judicial activism and interference. The industry leaders also wrote that if the ruling stands, then courts could overturn drug approvals without regard for science or evidence. They called for the reversal of his decision.4
Some researchers and providers expressed concern for the physical and mental health of women who need to end their pregnancies. Abortion access is especially important to victims of sexual assault and rape, and the availability of mifepristone through telehealth has been important to these victims when they become pregnant and do not want to continue the pregnancy.
“If that [access] is stripped away, we’re worried we’ll see some devastating effects,” says Kelly Cue Davis, PhD, MS, a professor at Edson College of Nursing and Health Innovation at Arizona State University.
Some rape survivors in abortion-ban states have found workarounds to obtaining an abortion, particularly through telemedicine. But if that ends, it could be harmful to their physical and mental health.
“Being forced to give birth as a rape victim can prolong the agony,” Davis says. “One of the primary things we can try to do when working with rape victims who had bodily autonomy and agency taken away from them is to make sure they have a sense of control and agency. Being forced to give birth takes that away again; it’s another way their agency is being stripped from them.”
The Supreme Court’s decision to overturn Roe and permit states to ban and drastically restrict abortions has wreaked havoc on people capable of pregnancy and abortion providers nationwide. Those practicing in abortion-ban states have had to stop most or all abortion care or move out of state. OB/GYNs and other providers working in clinics that provide abortions have been stressed to meet increased demand in their states as huge numbers of women travel to them for abortion care they cannot receive at home.
Delayed Care Can Cause Moral Distress
OB/GYNs have seen many cases of delayed care in abortion-ban states. They have experienced the moral distress of having to wait until a patient was at risk of death or permanent impairment before they could intervene, says Erika L. Sabbath, ScD, co-director of the Center for Work, Health, and Well-Being at Harvard T.H. Chan School of Public Health.
Sabbath and colleagues assessed the personal effect of the Dobbs decision on OB/GYNs working in general obstetrics, maternal-fetal medicine, and complex family planning. These providers experienced restrictions on counseling patients about their pregnancy options and could not make referrals to abortion care. They also experienced moral distress, fear of violating the law, depression, anxiety, and the desire to leave their states.5
“They talked about the fear of being arrested in front of their kids and lying awake at night and wondering about and worrying about certain cases,” Sabbath explains. “They worried about reputational damage and having their names dragged through the mud.”
What struck Sabbath and colleagues was the widespread moral distress and the declines in standards of care. (For more information, see the story in this issue on OB/GYNs and the effects of Dobbs.)
“These doctors cared for their patients and their well-being, and they’re trying to do the best they can for their patients under the current legal circumstance,” Sabbath says.
Depending on what the Supreme Court decides, the situation could worsen for both providers and patients. Several different scenarios could occur. The best outcome would be if two conservative justices join the three liberals to leave the FDA alone in its decisions over mifepristone. Another possibility is the court will decide that the FDA was correct to approve mifepristone in 2000, but it was incorrect to expand access to it through later decisions, such as allowing distribution via telehealth. The worst outcome would be if a majority of the court joined a decision that says mifepristone research and findings were not reviewed well enough by the FDA and the agency would have to pull the drug off the shelves until additional research is available. This would put the drug back on the drawing board, and it would be up to the companies that own the drug to spend millions on further research.
This decision also would have major repercussions for all drugs approved by the FDA. Any well-funded group could judge-shop, as did the anti-abortion groups that brought the initial lawsuit, to take any other drug off the market. It is possible that potential competitors could fund such a lawsuit to protect their market share of a competing drug. It also is possible that a Supreme Court decision that attacks the abortion drug becomes limited to the abortion drug, just as the Texas law allowing citizens to sue anyone who aids and assists someone obtaining an abortion has so far only been passed to block abortions but not to block gun purchases or other activities.
“If the Supreme Court rules there was not enough evidence at the time the decision to approve mifepristone was made, then we’d need to conduct more research and apply for the same approvals that we know are scientifically justified,” Upadhyay says. “It [would] take some time — a couple of years — but I think it would be the right way to move forward.”
REFERENCES
- Belluck P. CVS and Walgreens will begin selling abortion pills this month. The New York Times. March 1, 2024. https://www.nytimes.com/2024/0...
- Ungar L. More than six in 10 US abortions in 2023 were done by medication — a significant jump since 2020. AP News. March 19, 2024. https://apnews.com/article/abo...
- Upadhyay UD, Koenig LR, Meckstroth K, et al. Effectiveness and safety of telehealth medication abortion in the USA. Nat Med 2024;Feb 15. doi: 10.1038/s41591-024-02834-w. [Online ahead of print].
- Suliman S, Banks A, Levin J, et al. In support of FDA’s authority to regulate medicines. April 2023. https://docsend.com/view/2ahvm...
- Sabbath EL, McKetchnie SM, Arora KS, Buchbinder M. US obstetrician-gynecologists’ perceived impacts of post-Dobbs v. Jackson state abortion bans. JAMA Netw Open 2024;7:e2352109.
In June, the U.S. Supreme Court is expected to decide the fate of the abortion medication mifepristone — a decision that could undermine access to the medication at a time when major pharmacies and retailers have begun to offer the pill. Abortion rights advocates, reproductive health clinicians, and others are bracing for a decision that could upend access to safe, legal self-managed abortions for most or all women in the nation.
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