The Good, The Bad And The Ugly Of The Mifepristone Case In Texas
An anti-abortion, Christian org is suing the FDA to revoke a medication in the ‘abortion pill’ regimen. Meet two vital women researching self-managed care.
The “abortion pill” is actually a misnomer.
What is taken is actually two distinct medications — mifepristone and misoprostol — which together have been delivering safe and efficient (up to 87% even at 11 weeks) abortions for more than 20 years.
For a pregnancy to grow, it needs the hormone progesterone. Mifepristone, a synthetic steroid, blocks the body’s production of progesterone and halts gestation in its tracks. Misoprostol then deals with the aftermath, causing cervical softening, dilation, and uterine contractions, flushing out any tissue associated with the pregnancy.
To be clear, complications from pregnancy are a hundred times higher than those from abortion.
Or, put another way, you are 14x less likely to die from an induced abortion than having a live birth.
This is what makes the current case trying to ban mifepristone so maddening. Filed by a slew of anti-abortion organizations with Christian doctrine — led by Alliance for Hippocratic Medicine — the defendants are asking Judge Kacsmaryk of Amarillo, Texas (a Trump nomination of course) to revoke the FDA’s approval of mifepristone. (Multiple attempts to reach The Alliance Defending Freedom, who filed the case in November 2022, went unanswered.)
The case cites a slew of erroneous claims, accusing the FDA of failing to protect women and girls, “choosing politics over science,” using “accelerated drug approval authority” and disregarding “substantial evidence that chemical abortion drugs cause more complications than even surgical abortions.”
All this when medication abortions have proved to be the gold standard in safety and now account — for the first time in history — for more than half of all abortions in America.
And while this case is laughably flawed — much ink has been spilled decrying its legitimacy—but the sobering truth is, the truth doesn’t matter. Kacsmaryk could very well rescind a drug that provides safe, meaningful abortion access to millions, wherein the case would likely head to the Fifth Circuit Court of Appeals, a notoriously conservative and precedent-flouting court that sits in judgment on cases brought in Texas.
And they too could choose to uphold a prohibition of mifepristone.
“I think there’s a reason why we haven’t seen Texas voters go to the poll on this — what is done legislatively here is not, in general, representative of public opinion,” says Abigail Aiken, lead researcher of Project Sana at the University of Texas.
Project Sana studies the “who, what, and why” of self-managed medication abortion in the US, examining how policy decisions at the state and federal level impact demand for the abortion pill — especially through online telemedicine.
“I think there’s a small minority that’s very vocal and very well organized that’s kinda driving this kind of policy change,” she told me.
And Aiken is no stranger to vocal and small minorities wielding power over abortion. Reared in Northern Ireland where abortion was illegal and criminalized and raised under the shadow of Catholicism — Aiken told The New Yorker about her mother’s warning — “Do not get pregnant, that is one thing I cannot help you with” — she transmuted her fear into seminal research on self-managed abortion.
Aiken’s 2017 study on self-managed abortion with Rebecca Gomperts — the Dutch doctor behind Women on Web and Aid Access (more on that in a minute) — is largely credited with influencing Irish parliament to legalize abortion for women within the first twelve weeks of pregnancy.
“This work that began in the Irish context quickly became applicable here in the United States, and particularly in Texas where I live,” Aiken said.
“In some ways it does feel like watching Northern Ireland happen again in front of my eyes. Sometimes it’s not the most comfortable place to do this work, but it does feel like an important place to do it.”
Project Sana has traced the abortion pill access arc since the dawn of COVID, beginning with Governor Abbot’s near ban on surgical abortion — he deemed it a “non-essential medical procedure.” In that time Aiken saw a doubling of requests for the abortion pill.
“One major theme of this research in terms of policy impact is that every time you see an attempt to outlaw or severely restrict abortion, you don’t see abortion disappear because these laws don’t do anything to address the need for abortion.”
In fact, Aiken says, it’s quite the opposite. “The states with the most severe abortion restrictions are the ones with the highest requests for self-managed abortion using pills.”
And worse yet is the hypocrisy. Removing mifepristone from self-managed care will compound potential complications, hampering an already overburdened system riddled with barriers and doctors struggling to keep up.
Aiken says the effectiveness of self-managed abortion — that means the number of abortions completed using the pills alone with no extra help from a physician to empty the uterus — is on par with the clinic setting.
If mifepristone is banned, the country will be forced to pivot to a “misoprostol-only protocol” (the second drug in the two-step “abortion pill” process).
“If your whole thing is about safety and effectiveness, you’re doing nothing to increase that,” she says.
Project Sana’s latest paper in Perspectives not only outlines the encouraging efficacy rates of misoprostol, but its low cost (especially compared to mifepristone) and its availability in a variety of healthcare settings, especially pharmacies, “the most frequently visited healthcare setting in the US.”
Misoprostol is used in a host of non-abortion related settings, from the treatment of stomach ulcers and rheumatoid arthritis to the management of postpartum hemorrhage.
The research also points out that the dispensing of misoprostol is not restricted by the FDA’s Risk Evaluation and Mitigation Strategy (REMS) classification, which will increase access to telehealth in states where telehealth provision of medication abortion is possible.
In short, Misoprostol provides a silver lining in a dark cloud, but Aiken reminds us that because misoprostol is simply less effective than the two-step protocol, there will inevitably be more incomplete abortions, more complications, and a further hampering of our already-burdened physicians and healthcare system.
“These days, people are oftentimes hearing about self-management for the first time, but I always want to make sure people can understand and appreciate that this is not new,” says Aiken.
“Since there have been people, there’s been self-managed abortion. But what it means to self-manage is really what has changed. It’s been a big spectrum of different things — botanicals or herbs, self-harm. But it is increasingly likely to be abortion pills because of changes in access to that technology.”
For those who happen to live in states like California, New York, or Oregon, you can get the abortion pill via mail from a US-based provider. But for the slew of other states with near-bans or confusing restrictions — and with abortion legislation rapidly evolving, leaving millions in fear and at odds with their own bodies — there’s Aid Access.
Rebecca Gomperts first launched Women on Waves in 1999, an “abortion boat” providing legal abortions in international waters. In 2002, Women on Waves expanded its reach online to become Women on Web — an international telemedicine non-profit. 2018 saw the launch of its US-focused arm, Aid Access.
Currently, Aid Access is the only online telemedicine service providing the abortion pill to all 50 states — even where it’s technically illegal to do so. Aid Access is operating in a gray area that has left them, for now, largely untouchable by US legislation. All the doctors and medical staff are outside the country, and the pills are shipped from a pharmacy in India.
James Bopp, the general counsel of the National Right to Life Committee, told NBC there’s little his organization or allies can do against a group based outside the U.S. without control of the presidency or a new federal law. “The reality is state laws have limited extraterritorial effects,” he said.
More complicated still is the fact that Attorney General Merrick Garland has said states cannot enforce bans on abortion pills because the FDA approved the regimen, which preempts (overrules) state action.
There’s no current law in Texas that criminalizes a person for self-managing their abortion,” says Aiken.
“This isn’t to say you might not be surveilled, prosecuted, or harassed for doing it. There is still legal risk, which is why I don’t think we’re gonna see many other organizations like Aid Access spring up in response to increased demand, but it’s hard for legislators to make laws stick outside of their jurisdiction.”
For Dana Johnson, another researcher at Project Sana, her concerns are manifold around the fight to maintain the two-step abortion pill protocol.
“There’s always a way that people will weaponize aspects of our criminal legal system, the fact that this was filed in Amarillo is a really important reflection on Texas, but also on our democracy,” Johnson tells me.
People weren’t able to access abortion even before this lawsuit, she laments, citing all kinds of barriers from economics to racism. “It is so expensive, the Hyde Amendment still exists, restricting Medicaid funding for abortion — people are still unduly criminalized because of who they are and what they look like.”
Aiken urges us to consider how we talk about the right to abortion as well because technically, we’ve never had that right.
“The way that Roe was construed, it’s the right to choose abortion, it’s not the right to abortion. It’s an important distinction because it doesn’t guarantee any specific method and it doesn’t guarantee you access. And for so many people it has never been a choice — so is it even really a right if you can’t exercise it?”
But mutual aid has proven a powerful counterbalance to this historical lack. Johnson points to the irony that some of the most restrictive states, like Texas, in turn, offer some of the most progressive and far-reaching solutions — work that the government should be doing, but isn’t.
“People are like, ‘oh, it’s Texas,’ they’re always doing crazy stuff there,” says Johnson. “This attitude is hurtful because I think Texas is home to some of the most ingenious abortion access organizing — historically abortion funds have covered hundreds and hundreds and hundreds of miles to get people the care that they need.
“Repro kits, emergency contraception, sex-ed in a state that is huge and has very little Medicaid funding and very little sex education that is valid and gender inclusive and accurate. These grassroots organizations are providing social services and healthcare to an entire state. So, yeah, as a Texan, I’m incredibly proud of the organizers in it.”
We’re still waiting to hear what Judge Kacsmaryk decides — and if his decision will meaningfully affect the nation’s access to the abortion pill, but regardless of this particular case’s outcome, the relentless attack on reproductive rights is now part and parcel of our political landscape for the foreseeable future.
Johnson says that family — given and chosen alike — remains a vital lynchpin in protecting access. “As we go into a world where bans feel ever present, we need to think about how to help each other and actually get people the care they need.”
