Experts Offer Vital Insights on Mifepristone Safety, Efficacy, and Access

What you need to know about the mifepristone case coming to the Supreme Court, according to Rollins researchers

By Shelby Crosier

On March 26, the U.S. Supreme Court will hear oral arguments in a case that could limit access to mifepristone, a drug primarily used in medication abortion. This marks the first time that the court will weigh in on abortion since overturning Roe v. Wade in June 2022.

“We’ve seen past reproductive health policy change introduce confusion about what the current reality is,” says Whitney Rice, DrPH, director of The Center for Reproductive Health Research in the Southeast (RISE). “There’s a lot of conversation happening, and the fundamental evidence that we know about the safety and effectiveness of mifepristone is not always clear to the public. It could seem like this case is calling into question whether people can or should be accessing this safe method of abortion.”

Mifepristone is proven to be safe and effective. The upcoming hearing is not questioning the drug’s safety. Instead, the case is looking at how mifepristone is prescribed, which may have implications for access to the drug. We spoke with Rice and other researchers from RISE to learn more about the state of mifepristone access, the potential implications of the Supreme Court hearing and eventual decision, and what the public needs to know.

Mifepristone

Most abortions performed in the U.S. are medication abortions, including about 66% of abortions before nine weeks gestation. Typically, medication abortions use mifepristone in combination with another drug called misoprostol, a regimen that has been overwhelmingly shown to be safe and effective.

“In the U.S., the vast majority of medication abortions use a mifepristone and misoprostol protocol,” says Sara Redd, PhD, director of research translation at RISE. “Additionally, as of 2020, over 50% of non-hospital abortions are medication abortions, and that percentage is higher in Georgia.”

When the Food and Drug Administration (FDA) first approved mifepristone in 2000, it placed restrictions on its prescription and use to ensure safety. These restrictions are called the risk evaluation and mitigations strategy (REMS). In 2016, in response to new scientific evidence reaffirming the safety of mifepristone, the FDA lifted some of those restrictions.

One of the most significant changes was that mifepristone no longer had to be prescribed in person. This cleared the way for telemedicine abortion care, increasing abortion access for people across the country.

“We have a lot of research showing that you don't need to come into the clinic to be evaluated and receive the prescription in person for it to be a safe and effective process,” says Hayley McMahon, doctoral fellow at RISE.

Beyond telehealth abortion care being safe and effective, it is also beneficial to patients in many ways. Telehealth allows for increased privacy, flexibility in appointment times, and more access to appointments for those who live far from their nearest clinic, have limited transportation access, or experience other barriers getting to an in-person appointment. In 2021, the accessibility of medication abortion was further increased when the in-person dispensing requirement was removed from REMS, making it possible to mail mifepristone prescriptions directly to patients’ homes.

The Supreme Court Case

Arguments will be heard together for FDA v. Alliance for Hippocratic Medicine and Danco Laboratories, L.L.C. v. Alliance for Hippocratic Medicine, which challenge the 2016 and 2021 changes to mifepristone’s prescription and use guidelines. If the court rules to overturn these changes:

• Telemedicine could no longer be an option for prescribing mifepristone.
• Mifepristone could no longer be mailed to patients’ homes and would need to be picked up in person.
• Only doctors could be able to prescribe mifepristone, potentially removing the authority from pharmacists, nurse practitioners, and physician assistants.
• The gestational limit for mifepristone use could be lowered from 10 to seven weeks.
• The dosage of mifepristone and timing of the mifepristone and misoprostol regimen could change.

Although this decision would greatly limit access to medication abortion, it is important to note that the FDA’s initial 2000 approval of mifepristone is not in question in this case.

“The danger is less so that mifepristone would disappear, and more that we would likely see the in-person prescribing restriction come back,” says McMahon. “That would be really devastating, as telehealth is very important for a lot of folks to be able to access care.”

Implications for Health and Abortion Access

Because medication abortion is the most common type of abortion in the U.S., the majority of abortion seekers in the country would be affected by a decision that limits mifepristone access. Although the drug would still be available, those who live far from clinics, have limited transportation options, or deal with chronic health concerns that make it difficult to travel to appointments would have a much harder time getting the abortion care that they need. These concerns are especially relevant in states like Georgia.

“Changing people's ability to remotely receive care in our southeastern environment is particularly impactful, especially given the number of rural areas that are in our state,” says Rice. “In Georgia, we also disproportionately experience a number of health conditions that could make it more difficult for people to access in-person care, and we have a large population for whom work involves very labor intensive and time intensive activities that could make telemedicine a more accessible way to receive care.”

Additionally, abortion seekers would not be the only group affected by a decision that would make mifepristone less accessible. The drug is also used for a range of other purposes, including managing pregnancy loss, postpartum hemorrhaging, and treating uterine fibroids.

The Bottom Line

Mifepristone is safe and effective.

There is an overwhelming amount of scientific evidence showing that mifepristone is safe and effective. The studies being used to support the challenge in this case have been retracted by their publisher following more rigorous review.

Mifepristone is still available.

Although arguments will be heard on March 26, a decision in this case is not expected until the summer. In the meantime, there is no change to the accessibility of mifepristone.

“Nothing has changed yet,” says Redd. “The most important thing for me in advance of this case is reaffirming that abortion care with mifepristone is still available and that it's not going anywhere just yet.”