Access to Mifepristone Still in Legal Limbo
April 1, 2023
EXECUTIVE SUMMARY
A federal judge may block the use of the safe and effective abortion drug mifepristone after hearing a lawsuit by an anti-abortion organization.
- Twelve reproductive rights states sued the Food and Drug Administration, arguing the agency should remove special restrictions on mifepristone to improve accessibility.
- Misoprostol, the second drug used in medication abortion in the United States, can be used alone, although it is less effective than the two-drug regimen.
- Researchers and reproductive rights advocates expect to see more legal attacks on abortion and contraception access in the United States.
Women on social media shared stories and fear about losing access to the safe and effective abortion medication mifepristone in the weeks leading up to a federal judge’s decision on a lawsuit. An anti-abortion group claimed the Food and Drug Administration (FDA) had improperly approved mifepristone in 2000.
Twelve state attorneys general filed a lawsuit in late February 2023 that takes the opposite approach. They asked a different court to remove the special restrictions the FDA applies to mifepristone. They also asked the court to declare that the FDA’s approval of mifepristone is lawful and legal, saying the FDA should not remove mifepristone from the market.1
Anti-abortion group Alliance for Hippocratic Medicine filed a lawsuit in Amarillo, TX. It will be decided by U.S. District Judge Matthew Kacsmaryk, an appointee of former President Donald Trump. Kacsmaryk has expressed opinions based on his personal religious views and has issued rulings considered anti-birth control and anti-LGBTQ.2
Kacsmaryk is the same judge who ruled in late 2022 in Deanda v. Becerra that the Title X Family Planning Program violates parental rights and state and federal law by mandating providers protect minor clients’ confidentiality when they obtain contraception. His decision could block access to affordable contraception for millions of adolescents.3
The ruling had not been announced as of press time, but access to the safe drug still is in jeopardy in many states that ban abortion.
The federal legal challenges may not be over. This reality places women’s lives in danger during miscarriage, and it makes mifepristone difficult to obtain in abortion-ban states.
Mifepristone has been used safely worldwide for more than 30 years. It is used for more than half of all abortions in the United States. Still, some reproductive health leaders have feared Kacsmaryk would baselessly decide against the drug.
The decision could end production and legal distribution of mifepristone in every state, including California, New York, and other states that have passed state laws protecting women’s right to abortion care.2
The judge’s decision does not mean every person will have easy access to mifepristone. Anti-abortion groups likely will not stop with the one lawsuit.
“I think the attacks on medication abortion will continue,” says Ushma Upadhyay, PhD, MPH, a professor at the University of California, San Francisco. “Medication abortion will continue to be a target for anti-abortion politics. I’ve been studying abortion safety for over 10 years, and [mifepristone] has a 99% [safety] rating, so there was no basis for that lawsuit. It was not rooted in any evidence.”
Even if mifepristone is unavailable, abortion clinics and OB/GYNs could prescribe misoprostol, the second abortion pill. But that drug is less effective at ending a pregnancy, can cause more side effects, and cannot be prescribed for an abortion in states that ban all abortions.
Misoprostol an Option, but Less Effective
The results of a recent study revealed misoprostol is less effective than mifepristone and carries a greater complication rate, says Rebecca Gomperts, MD, PhD, founder of Aid Access in Vienna, Austria. Aid Access provides medication abortion pills to women worldwide, including those who live in countries or states that ban or restrict access. Gomperts co-authored the study on misoprostol.4
“We’ve seen that 88% or 87% have a complete abortion without surgical intervention when using misoprostol, and that’s too low,” Gomperts says. “Where half of women use medication abortion, there would be so many who would need a surgical intervention.”
The evidence of mifepristone’s safety is well-researched. To claim the drug is not safe is a purely political ploy, Gomperts notes. “There is no drug that is safer than mifepristone,” she says. “It’s the misoprostol alone that causes bleeding, and mifepristone is much safer than Viagra; it’s an essential medicine of the World Health Organization.”
According to anecdotal reports, women in Texas and other border states are using misoprostol alone when they cannot access mifepristone from an out-of-state abortion clinic or pharmacy. It is not a good alternative to a regimen that includes both mifepristone and misoprostol, but it is an option if a woman cannot access a physician or clinic that performs procedural abortions or prescribes both mifepristone and misoprostol.
“If there’s nothing else, go to misoprostol alone,” Gomperts explains. “But its complication rate is higher, especially in states like Texas where hospitals do not want to provide normal miscarriage care. If women are presenting to them with bleeding, they won’t give them the medical care they need.”
When providers cannot prescribe mifepristone followed by misoprostol, the maternal mortality risk is higher. “They’ll have incomplete abortions and miscarriages treated improperly because mifepristone is used for miscarriages alone,” Gomperts says.
Gomperts and colleagues’ research offers an alternative for people who still want a medication abortion or who face too many obstacles to drive to a state with legal abortion clinics.
“Misoprostol is a great option. We have a growing body of evidence [supporting its use], and this study adds to that,” says Dana M. Johnson, lead study author and PhD candidate at the LBJ School of Public Affairs at the University of Texas at Austin. For many people around the world, misoprostol is the only pill available for medication abortion, she notes.
A decision to not block mifepristone would be a victory for reproductive rights in line with science. “It’s always reassuring when the court rules in line with science,” Johnson says. (For more information, see the story in this issue on misoprostol.)
Even with misoprostol as a back-up plan, the prospect of losing one of the safest and most effective reproductive health medications was enough to cause OB/GYNs and scientists to check the news all day on Feb. 24, which was when the judge could have blocked mifepristone pending a final decision.
Loss Could Harm Women’s Health
Losing mifepristone would harm women’s health. “People have fewer painful side effects when using mifepristone, which is really, really effective,” Johnson says. “Imagining a world without mifepristone, which is backed by science, is terrifying and hard to comprehend. I’m also terrified when any method of abortion is banned. It falls on communities of color the most, and communities of low-income and young people and those who were historically cut out from abortion access, in general.”
Because of relentless legal challenges, the fight is ongoing to make medication abortion more accessible, especially for vulnerable women in states that have banned mail order medication abortion and/or all abortions.
“State-level attacks will continue in some states, including Texas, which has tried to restrict medication abortion in various ways,” Johnson says. “Our job as researchers is to continue to study the effectiveness of things we know.”
Kacsmaryk’s 2022 decision to block people younger than 18 years of age from obtaining birth control at Title X clinics is part of a pattern of judge-shopping by anti-abortion groups and other extremists, Johnson notes. “They strategically file certain cases in certain judgeships so certain judges will see them,” she explains.3
Often, women denied access to reproductive health medication in their own states will seek access via telemedicine from online and international sources.
Aid Access, the online telemedicine service for self-managed medication abortion, saw a spike in requests for medication abortion pills in the two months following the U.S. Supreme Court’s 2022 decision to overturn Roe v. Wade.5 The five states that recorded the greatest increases per week in seeking medication abortion were Louisiana, Mississippi, Arkansas, Alabama, and Oklahoma. The requests tripled or nearly tripled in those five states, all of which enacted abortion bans.4
Aid Access will continue to provide abortion medication via telemedicine to any people in the world and in the United States, regardless of their nation’s or state’s abortion laws, Gomperts says.
“We have upscaled, and there is a team reviewing health requests and doctors reviewing health requests,” she says. “We make sure we can help everybody.”
Also, people can order the abortion pills in advance, so they do not have to wait for weeks to receive pills by mail when they need them.
“We offer advance provision because it’s very important people have medication at hand when it’s difficult to get,” Gomperts says. “If people have it in their medicine cabinet, like any other medication, then there’s no waiting time.”
People also can use the medication as an extended emergency contraception, Gomperts adds.
REFERENCES
- Belluck P. 12 states sue F.D.A., seeking removal of special restrictions on abortion pill. The New York Times. Feb. 24, 2023.
- Weiss H. The most common abortion method is in danger in every state. Time. Feb. 15, 2023.
- Johnson D, Lindberg L. Birth control access is under threat after Texas judge’s ruling against Title X. Teen Vogue. Jan. 31, 2023.
- Johnson DM, Michels-Gualtieri M, Gomperts R, Aiken ARA. Safety and effectiveness of self-managed abortion using misoprostol alone acquired from an online telemedicine service in the United States. Perspect Sex Reprod Health 2023;Feb 6. doi: 10.1363/psrh.12219. [Online ahead of print].
- Aiken ARA, Starling JE, Scott JG, Gomperts R. Requests for self-managed medication abortion provided using online telemedicine in 30 US states before and after the Dobbs v Jackson Women’s Health Organization decision. JAMA 2022;328:1768-1770.
A federal judge may block the use of the safe and effective abortion drug mifepristone after hearing a lawsuit by an anti-abortion organization. The group claimed the FDA had improperly approved mifepristone in 2000.
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