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      ‘A gamechanger’: this simple device could help fight the war on abortion rights in the US

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      Joan Fleischman has always had people flying in from across the world to her private abortion practice in Manhattan. In the two decades her clinic has been open, she has seen clients from far-flung places, such as Ireland, the Bahamas and Mexico, who couldn’t get abortions in their home countries. In the last year, that changed. Since the US federal right to abortion was overturned in June 2022, she is now more likely to see patients flying in from her own country.Often they are from Texas, sometimes Ohio, or Florida. Some with links to the city, others with none.After years of providing abortion care, Fleischman, 60, still finds these trips shocking. “Usually if somebody needs unusual medical care, they are willing to fly around the world for it – like for advanced neurosurgery or something. It’s always struck me as incredible that people are flying to me for the most simple procedure.”There’s a reason people fly to see Fleischman. She provides abortions through manual uterine aspiration – using a small, hand-held device to remove pregnancy tissue. The device is gentle enough that the tissue often comes out almost completely intact. It is also a quick and discreet procedure where a patient might be in and out of the door in less than an hour.Fleischman is co-founder of the MYA Network, a network of primary care clinics and clinicians in 16 states. They believe the tool could be radical in the hands of more primary care clinicians – clinicians they are amping up to train.The time to do that, they say, is now. The future of mifepristone, a major abortion pill used in more than half the abortions in the US, is in question due to a lawsuit brought by anti-abortion groups seeking to overturn the FDA’s approval of the drug. It could be determined by the same supreme court that ruled last year to overturn Roe v Wade. Manual aspiration is not new: it is used by many big abortion clinics across the US. But those are are notoriously over-stretched. In 2020, before Roe v Wade was overturned, 38% of reproductive-aged women lived in counties with no abortion provider at all.Especially given the threat to mifepristone, the MYA Network believes that primary care clinicians, who are vastly more common than abortion providers, are well-placed to help.But while more than 73% of primary care doctors believe abortion care to be within their scope of practice, a tiny fraction – less than 10% – of primary care doctors actually provide it.The network is planning to unveil an online curriculum and in-person trainings for the procedure, which many of the clinicians and institutions in the network have already been doing in their own states.“The number of clinicians who could be trained would be limitless,” says Michele Gomez, one of the doctors in the MYA network of clinicians.“There are so many clinicians out there who want to do something to help but just don’t know how, and this information and support could be a gamechanger.”As a young woman, Joan Fleischman often felt compromised. She frequently traveled overseas as a teenager to do basic aid work with a volunteer group, and would feel fear and humiliation from the unwanted sexual attention she would receive. That was the beginning of her understanding, as she describes it, of the constant vulnerability women walk around with.By the age of 18, Fleischman had her first abortion – an experience she describes as routine, mundane even. The pregnancy came as she started her first year at the University of Chicago, and was the least of her concerns. “It was a no brainer. I was like, ‘Pregnant? Nope, I’m going to be a doctor.’ So I went to Planned Parenthood and took care of it,” says Fleischman.It wasn’t until she started providing abortions that she even thought about the experience again.Fleischman was in her 30s, living in New York and already trained as a family practice doctor, when she saw an advertisement offering to teach doctors how to do surgical abortions.“I realized that after all these years in training, I’d never got to even see an abortion. I had saved lives, helped people at the height of the Aids crisis. I had delivered babies. These are things a family doctor does,” she says. “I was like, ‘why? That’s ridiculous.’ That’s where the passion started.”Fleischman took up more training, learning to perform abortions at a Planned Parenthood, in 1995.Planned Parenthood – as Fleischman pointed out herself – is the place where people “go to get it done”. It is a vital lifeline for many people, providing hundreds of thousands of abortions every year, many to low-income and uninsured clients.But the efficiency of their service contrasted with Fleischman’s training as a family doctor – which emphasizes the importance of the doctor-patient relationship. She was used to that relationship entailing a level of intimacy – her work involved home visits with patients, and entering lifelong relationships with them and their families.Fleischman recalls her Planned Parenthood training:“Women went station to station. They got their blood drawn, and then they sat in a little waiting room with other people. They got their ultrasound; they sat in another little waiting room, always with paper gowns on. They had been fasting for the whole night before. They saw a counsellor. Then they were in a bigger waiting room. And then they got called by name, to come in for their procedure. The surgeon went from room to room to room, doing 50-60 abortions a day.”She wanted to personalize the experience. For patients to be able to come in with their partners, to be talked through their options and their concerns, fully. “I just felt so disconnected. It seemed to me that the doctor was really a technician emptying uteruses,” she continues.“I was like, ‘I want to create a different model. I want people to have a different experience going through this’.”As the US is learning, ethical quandaries always arise when abortion is banned: what to do for the woman who turns up septic after a failed, self managed abortion? How to deal with life-threatening pregnancies that require intervention but also require an abortion? What about cases of rape, incest or pregnant children?Essentially: how much pain is the state willing to impose on people when it restricts reproductive freedom?In Bangladesh, a sort of answer to some of these questions came following the 1971 civil war, during which soldiers abducted Hindu and Bihari Muslim women and set up rape camps. Pregnancy as a result of rape skyrocketed; in the following years, suicide and maternal mortality also shot up. Abortions, of course, did not stop happening. In 1978, while abortion remained illegal, an estimated 800,000 abortions took place in the country, resulting in around 8,000 deaths.“Menstrual regulation”, as it came to be known – using the same manual aspiration technique that Fleischman now uses – became a sort of legal loophole, allowing safe abortions for early pregnancies.By 1974, menstrual regulation was legal and by 1979, Bangladesh started providing the procedure through its national family planning program.Now, one might walk through a busy street in Bangladesh and find a sign advertising menstrual regulation in a country where, at least officially, abortion is only allowed in life-threatening situations. A woman simply comes in and explains she has missed her period. She doesn’t take a pregnancy test before the procedure, and nobody asks her to. As long as she sees the clinician before 12 weeks, they will “restore her period” for her.“It’s just a clever policy, a wink and a nod – everybody knows what’s going on. It’s kind of a recognition that women need this care,” says Bill Powell, a senior medical scientist at IPAS, an international organization that trains medical professionals across the world to use manual aspiration.It also gives doctors discretion without explicitly violating the law. “They say: ‘I know if I don’t provide this care, this woman is going to go off and do something that is unsafe, and she’ll be back to my facility ill, needing emergency care, so therefore, I am saving her life by providing this procedure’,” Powell explains.Fleischman, who worked in Bangladesh in her youth, and her colleagues in the MYA network are adamant they are only proposing manual aspiration be used legally in the US – for abortion care where it is legal, and miscarriage management where it is not. But its use in ordinary medical settings could still provide a radical opportunity in the US, she says, by expanding the number of clinicians who can easily perform the procedure up until 12 weeks.Others have touted this idea, in a slightly different way: anyone can learn to use a manual aspiration device, and manage their own abortions, some activists argue. All they need to learn to do is to insert a cannula, which is like a large straw, through the natural opening of the cervix, and then attach the aspiration device. The device is like a syringe, which creates a vacuum. Once the pressure is released, the contents of the uterus are gently removed. The self-management option has other advantages – like cutting out the middle man in a climate where doctors are increasingly scared to provide abortion care, and equipping people with self knowledge when the future of access to abortion is unclear.Fleischman understands the necessity of self-managed abortion, especially in places where the procedure is illegal. But she believes that after receiving care, people should always be able to follow up with a clinician who knows their case if anything goes wrong, or even if it doesn’t. It dismays her that people are living in a climate in the US where they might not have that option; where people might be too scared to look for help; and where they may suffer with complications alone in the rare instances when something does go wrong.In states where abortion is legal, manual aspiration provides the opportunity to treat abortion like mainstream medicine, rather than something that’s siloed into abortion clinics, which are visible, small in number and under constant threat.The case brought by anti-abortion groups against the FDA’s approval of mifepristone – which is one of two abortion drugs used in more than half of all abortions in the US – will almost certainly be decided by the supreme court. The uncertainly over its future, Fleischman argues, could make the expanded use of manual aspiration critical to preserving abortion and miscarriage care.Some providers may switch to abortions using only the second drug, misoprostol. But misoprostol-only abortions are slightly less effective, and more often require care for incomplete abortions. That could result in straining already stretched abortion clinics, which will likely have more people knocking at their doors for both surgical abortions and follow-up care.With manual aspiration on the other hand, doctors can be mostly certain that the procedure is complete before the patient leaves the state.And in states with bans, clinicians could be trained to use the device to treat miscarriages. “It’s useful even where you are not allowed to provide induced abortion care … [to treat] miscarriage, or spontaneous abortion,” explains Ian Bennett, a family planning doctor who is part of the MYA network and a professor at the University of Washington.Bennett trains several dozen students a year in manual aspiration, teaching them the procedure as part of their regular medical training, and says students are actively seeking out this instruction in the new, post-Roe environment.Students “are selecting programmes where abortion care is integrated into their training, even over some that might be more prestigious,” he says.Clinicians in areas that border states with bans, which have seen big increases in demand for abortion services as a result, are also a target for training, as are “red parts of blue states”, explains Gomez. Clinicians in states where abortion is legal, who want to do something to fight the war on abortion could easily do so by integrating abortion into their practices, Fleischman and her colleagues say.“It’s done in a couple of minutes,” explains Fleischman.“When it’s done, you know that it’s done. There’s very few bleeding issues. You walk into an office, and an hour later, it’s resolved. I have people flying in and out of Dubai for this procedure. They schedule the appointment, they come in, and they depart that afternoon,” she continues.“There’s absolutely no reason this shouldn’t just be part of regular medicine.” More

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      To protect abortion access, the FDA should decline to enforce a mifepristone ban | David S Cohen, Greer Donley and Rachel Rebouché

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      On Friday, the nation faced dueling decisions from federal judges regarding the first drug in a medication abortion: mifepristone. A judge in Texas ruled that the Food and Drug Administration (FDA) likely improperly approved the drug, putting mifepristone’s approval on hold while the case plays out (though this order won’t take effect until late Friday this week). Minutes later, a judge in Washington state ruled that the FDA could not change the status quo regarding mifepristone’s availability.In response to these two cases and two other less-publicized cases involving the FDA and medication abortion, the agency needs to chart a course consistent with its mission to protect patient health and to follow the evidence. As the Biden administration has stated, protecting medication abortion is a public health imperative now that states can ban all abortion outright. If the agency does not respond to these conflicting rulings in a manner tailored to provide the greatest access possible to medication abortion, it will be telling of Biden’s commitment to reproductive justice.Though the case in Texas has garnered enormous attention, it is not the only case thrusting the FDA into the center of the abortion debate. The others have the opposite goal of improving access to the drug. The litigation in Washington state, not widely discussed until Friday, centered around the FDA’s special and onerous regulation of medication abortion. Eighteen state attorneys general sued the FDA arguing that the agency’s overregulation is not justified by the statute or the drug’s safety and must be lifted. If successful on appeal, this would ensure mifepristone is treated like other prescription drugs – prescribed through any provider and accessible at any pharmacy.Plaintiffs in two other cases are pushing even further, trying to use the FDA’s special regulation of mifepristone to argue that a state cannot ban or overregulate the drug. These lawsuits, filed respectively by the generic manufacturer of mifepristone in West Virginia and a physician in North Carolina, might restore access to medication abortion across the country. The plaintiffs argue that federal approval of mifepristone trumps state abortion laws, essentially forcing all states to allow medication abortion as regulated by the FDA.The FDA is caught in the crosshairs. Though the agency prides itself on scientific independence and seeks to avoid the appearance of partisanship, any reaction the agency has to these cases – even a decision not to act – will appear political to one side. Nonetheless, the FDA must push forward to ensure access to this critical drug.Starting with the two cases just decided, the agency can comply with both by announcing that it will exercise enforcement discretion. Enforcement discretion allows the agency to provide safe harbor for technical violations of law. So even if mifepristone becomes an unapproved drug per the Texas order, the agency could announce that it would not pursue action against the entities that market or dispense the drug to maintain the status quo as required by the Washington case.This would not require the agency to “ignore” the Texas order, as some have suggested. Rather, enforcement discretion is a normal part of the FDA’s operation and only relevant if the drug becomes unapproved as ordered. The FDA could exercise this discretion without being ordered to by the Washington court, but the Washington case provides enormous political cover for the agency to use this discretion.Repercussions for patient and public health could result from the FDA failing to clearly exercise its enforcement discretion. Clinicians may turn to a different medication abortion regimen that does not include mifepristone and is outside of current FDA regulation. Though alternative regimens will be vital to maintaining abortion access if mifepristone becomes inaccessible, they are slightly less effective and, more importantly, will upend what has been the uniform, established protocol for a medication abortion in the United States for over two decades. Relatedly, confusion is sure to reign after the Texas decision unless the FDA speaks in a clear and timely voice. Already, certain abortion providers have indicated that they will continue to dispense mifepristone regardless of the order in Texas unless the FDA tells them they cannot.As requested by plaintiffs in the Washington case, the FDA could also start the process to remove the unnecessary barriers to accessing mifepristone, which every relevant medical organization agrees are not medically necessary. These barriers make abortion less accessible without any benefit for patient safety. Though the FDA has repealed parts of these unduly restrictive rules over the last decade, the FDA should abandon the remaining restrictions, which are also contradicted by the best evidence. These policies do not make the agency seem evenhanded; they make it seem unscientific. The agency should not wait for the Washington court to order this – it should start the process now.In the pre-emption cases, the FDA could help the effort to restore access to early abortion in states with abortion bans by embracing the theory that the federal agency’s regulation of medication abortion trumps state law. The Department of Justice has already signaled its agreement, but the FDA has been silent. The FDA has spent decades assessing the risks and benefits of medication abortion, examining and re-examining the evidence even decades after its approval in 2000. States should not be able to override that authority and create a public health crisis by banning a safe and effective medication.The agency, however, has appeared unwilling to remove the remaining unnecessary barriers to mifepristone or support pre-emption at this juncture. Indeed, it has said nothing about pre-emption and is opposing the attorneys general in the Washington case – a fact that may surprise people who think the Biden administration is doing all it can to support abortion access. Given the current public health crisis, the FDA must be bolder in its support of reproductive healthcare.Try as it might, the FDA cannot escape the abortion debate. Instead of trying to play both sides, the agency must act now by following the science and protecting the public’s health to the best of its ability. Protecting access to safe abortion is the way to do that.
      David S Cohen, a law professor at Drexel University, is a co-author of Obstacle Course: The Everyday Struggle to Get an Abortion in America, a board member of the Abortion Care Network and a consulting attorney with the Women’s Law Project
      Greer Donley is a law professor at the University of Pittsburgh and a board member of the Women’s Law Project
      Rachel Rebouché is the dean of the Temple University Beasley School of Law and a faculty fellow at the Center for Public Health Law Research More

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      Fate of US abortion drug hangs in balance ahead of Friday deadline

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      FDA authorization for a key abortion drug could be nullified after Friday, unless an appeals court acts on a Biden administration request to block last week’s ruling suspending approval of the drug.The drug, mifepristone, is used in more than half of all the abortions in the US. The ruling, issued by a federal judge in Texas, applies across the country.Writing that the ruling would “inflict grave harm on women, the medical system, and the public” if it went into effect, the Department of Justice on Monday requested the fifth US circuit court of appeals temporarily block Judge Matthew Kacsmaryk’s ruling while the appeals process plays out.The issue may ultimately fall into the hands of the US supreme court and its conservative supermajority, which eradicated abortion rights last year by overturning Roe v Wade.Kacsmaryk stayed his decision for seven days to allow the Biden administration time to appeal. Shortly after the ruling from Texas, Obama-appointed Washington district judge Thomas Rice issued a contradictory ruling that directs the FDA to keep the drug available in 17 states.The dueling opinions set the stage for the supreme court to possibly intervene.“On one hand, you have a ruling that says to defer to the expertise of the FDA and keep the status quo while another says to second-guess the FDA with junk science,” says David S Cohen, law professor at Drexel University, who focuses on reproductive rights.“When you have different rulings from different federal courts it is more likely for the US supreme court to get involved.”The New Orleans-based appellate court is one of the most conservative in the US. Republican appointees comprise three-quarters of its bench, with six judges nominated by former President Donald Trump. The court has routinely ruled against the Biden administration and on behalf of Texas’s abortion laws.If the appeals court declines to put a hold on Kacsmaryk’s ruling, then the Biden administration would likely appeal to the high court.“It’s possible that the mifepristone issue makes its way to the [Supreme] Court this week, either because the Fifth Circuit refuses to even temporarily pause Kacsmaryk’s ruling, or because it takes too long to do anything,” writes Steve Vladeck, a constitutional law professor at The University of Texas.In his ruling, Kacsmaryk echoed the arguments of the anti-abortion groups that brought the case, writing that the FDA disregarded science that the drug causes harm, despite repeated studies finding it extremely safe. Legal experts say that the decision – the first time the judiciary has intervened to overturn FDA approval of a drug – could create a precedent that throws the entire drug approvals system into disarray.More than 250 pharmaceutical and biomedical companies who strongly denounced Kacsmaryk’s ruling in an open letter and warned that it could upend the FDA approval process as well as the entire US healthcare system.“Judicial activism will not stop here,” they cautioned. “If courts can overturn drug approvals without regard for science and evidence, or for the complexity required to fully vet the safety and efficacy of new drugs, any medicine is at risk for the same outcome as mifepristone.”Mifepristone is used for abortion, miscarriage management and other medical care. If access to the drug is upended, abortion providers have said they will continue to prescribe the second of the two-drug protocol for abortions. However, that drug, misoprostol, has been found to be somewhat less effective and associated with more painful side effects than the combination of pills.With the mifepristone in doubt, the Biden administration asked Rice, the district judge in Washington, for clarification on how to proceed if the Texas ruling goes into effect, given that his decision orders the government to take no action that would hinder its availability.Legal experts have argued that the FDA does not need to enforce Kacsmaryk’s ruling, even if it goes into effect.The ruling does not formally compel the FDA to seize the pills and take them off the market, Cohen says, and leaves the door open for the Biden administration to apply what’s called “enforcement discretion”, which would entail issuing guidance protecting the distribution of mifepristone. In the past, the FDA has granted drug manufacturers this type of safe harbor even in the absence of agency authorization, including for infant formula.“The ruling does not force the FDA to do anything,” says Cohen. “It’s up to the FDA to determine what to do next. They can use enforcement discretion to protect access to mifepristone. We shouldn’t read into Kacsmaryk’s ruling as having more power than it does – it is limited – and there’s a huge amount of authority the FDA can retain.” More

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      US appeals Texas judge’s ruling to suspend abortion pill approval

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      The US government on Monday appealed a Texas judge’s decision to suspend the Food and Drug Administration’s 23-year-old approval of a key abortion drug, saying the ruling endangered women’s health by blocking access to a pill long deemed safe.In a filing with the 5th US circuit court of appeals, the Department of Justice (DoJ) called judge Matthew Kacsmaryk’s decision on the drug mifepristone “especially unwarranted” because it would undermine the FDA’s scientific judgment and harm women for whom the drug is medically necessary.The DoJ also said the anti-abortion groups that sought to overturn the FDA’s approval had no right to sue in the first place, saying they could not show they were harmed and had left the approval unchallenged for years.Kacsmaryk’s decision “upended decades of reliance by blocking FDA’s approval of mifepristone and depriving patients of access to this safe and effective treatment, based on the court’s own misguided assessment of the drug’s safety,” the department said.Lawyers for the anti-abortion groups did not immediately respond to requests for comment.Kacsmaryk, a district judge appointed by former Republican president Donald Trump, had ruled on Friday that the FDA exceeded its authority by ignoring mifepristone’s risks and relying on “plainly unsound reasoning” when approving it.The judge, who works in Amarillo, Texas, stayed his ruling for seven days to allow the Biden administration time to appeal.In Monday’s filing, the justice department asked that Kacsmaryk’s stay remain in place until all appeals, including if necessary to the US supreme court, are resolved.Mifepristone is part of a two-drug regimen, also including misoprostol, for medication abortions in the first 10 weeks of pregnancy. The drugs account for more than half of all US abortions.Kacsmaryk ruled just 18 minutes before a federal judge in Washington state issued a contradictory ruling that directed the FDA to keep the drug available in 17 states.In a Monday filing in that case, the justice department asked the judge there to clarify what should happen if Kacsmaryk’s order took effect.The conflicting rulings could foreshadow a resolution by the supreme court, which last June overturned the 1973 Roe v Wade decision, eliminating a constitutional right to abortion.The supreme court has a 6-3 conservative majority. The New Orleans-based fifth circuit also has a conservative reputation, with three-quarters of its active judges appointed by Republican presidents.“This administration stands by the FDA and is prepared for this legal fight, and we will continue our work to protect reproductive rights,” White House spokesperson Karine Jean-Pierre said.Monday’s appeal came in a case brought by anti-abortion groups led by the Alliance for Hippocratic Medicine, which was formed last August.They accused the FDA of failing to consider during its approval process for mifepristone the drug’s safety when used by girls under age 18.The plaintiffs sought a sympathetic court by suing in Amarillo, where Kacsmaryk is the only federal district judge.Kacsmaryk had written critically about Roe v Wade, and the former Christian legal activist’s courtroom is a popular destination for conservatives challenging Biden policies.Twelve US states ban abortion, while 14 others ban it at some point after six to 22 weeks of pregnancy, according to the nonprofit Guttmacher Institute, which supports abortion rights. More

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      Wyoming becomes first US state to outlaw use of abortion pills

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      Wyoming has become the first US state to outlaw the use or prescription of medication abortion pills after the governor, Mark Gordon, signed into law a bill that was passed by the state’s Republican-controlled legislature earlier this month.The crux of the two-page Wyoming bill is a provision making it illegal to “prescribe, dispense, distribute, sell or use any drug for the purpose of procuring or performing an abortion”.So-called “morning-after” pills, prescription contraceptive medication used after sex but before a pregnancy can be confirmed, are exempted from the ban.The measure also includes an exemption for any treatment necessary to protect a woman “from an imminent peril that substantially endangers her life or health”, as well as any treatment of a “natural miscarriage according to currently accepted medical guidelines”.Violation of the ban is to be treated as a criminal misdemeanor, punishable by up to six months in jail and a fine of up to $9,000.The measure stipulates that a woman “upon whom a chemical abortion is performed or attempted shall not be criminally prosecuted”.In a statement, Wyoming ACLU advocacy director Antonio Serrano criticised the governor’s decision to sign the law.“A person’s health, not politics, should guide important medical decisions – including the decision to have an abortion,” Serrano said.The governor said he was also allowing enactment, without his signature, of a separate bill passed by state lawmakers to prohibit conventional abortion procedures except when necessary to protect the health and life of the mother, or in case of rape or incest. Exception is also permitted to end a pregnancy if doctors determine there to be a lethal abnormality of the foetus.Wyoming’s new law comes as a rightwing push to crack down on medication abortions gathers momentum, with a federal judge in Texas currently considering a nationwide ban on the abortion pill mifepristone in response to a lawsuit by anti-abortion groups.A two pill combination of mifepristone and another drug is the most common form of abortion in the US.Medication abortions were the preferred method for ending pregnancy in the US even before the supreme court overturned Roe v Wade, the ruling that protected the right to abortion for nearly five decades.Since that decision last June, abortion restrictions have been up to states and the landscape has shifted quickly. Thirteen states are now enforcing bans on abortion at any point in pregnancy, and one more, Georgia, bans it once cardiac activity can be detected, or at about six weeks’ gestation.Courts have put on hold enforcement of abortion bans or deep restrictions in Arizona, Indiana, Montana, Ohio, South Carolina, Utah and Wyoming. Idaho courts have forced the state to allow abortions during medical emergencies.Reuters and Associated Press contributed to this report More

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      The right is stealthily working to remove Americans’ access to abortion medication | Moira Donegan

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      This week a Republican-appointed federal judge weighed whether to grant an injunction that could remove mifepristone, the drug used in most American abortions, from the market nationwide. And the hearing almost happened in secret.US district court judge Matthew Kacsmaryk had initially planned to keep Wednesday’s hearing in the case – in which a group of rightwing anti-abortion groups are suing the FDA to reverse its 20-year-old approval of mifepristone – quiet. In a conference call with lawyers for the anti-choice groups and the Department of Justice, Kacsmaryk asked attorneys not to disclose the existence of the hearing (“This is not a gag order,” he said repeatedly), and said that the event would only be made public late on Tuesday to minimize popular awareness. “It may even be after business hours.” The judge’s courtroom in Amarillo, Texas, is hours away from any major city. It was only because of a press leak that the hearing was known to the public at all.It was just one of many of the alarming irregularities in the lawsuit, in which Kacsmaryk seems poised to grant the plaintiffs’ wish and issue an injunction that will radically reduce access to abortion nationwide.For one thing, the plaintiffs’ standing is exceptionally shaky: it’s not clear why the collection of abortion opponents – including one doctor, George Delgado, whose attempt to design an abortion-reversal clinical trial sent 25% of the test subjects to the hospital – have standing to sue the FDA. It’s especially unclear why they have standing to sue in Amarillo; the federal judicial district has become a popular venue for rightwing litigation in part because Kacsmaryk, an exceptionally conservative jurist willing to publish poorly reasoned, policy-driven opinions, is the only federal judge there.For another thing, the plaintiffs’ requests are exceptionally far-reaching. The anti-abortion groups want Kacsmaryk to declare the FDA’s approval of mifepristone illegal, even though the drug has been available in the US, and proven to be safe, for more than 20 years, and even though a judicial reversal of FDA approval for a medication would be highly unusual and only dubiously legal. At the hearing on Wednesday, lawyers for the plaintiffs acknowledged that there was no precedent for the court to order the suspension of a long-approved medication. If Kacsmaryk approves the injunction – and all indications are that he will – the drug could become inaccessible nationwide, even in Democratic-controlled states where abortion is legal.For another thing, the plaintiffs’ claims are so profoundly divorced from fact that it is difficult to believe that they are being made in good faith. The anti-abortion groups – including the doctor whose study sent women to the hospital – say that they are challenging the drug because they believe, falsely, that mifepristone is unsafe. Lawyers from the Alliance Defending Freedom, the rightwing legal outfit that is representing the plaintiffs and which is designated as a hate group by the Southern Poverty Law Center, pursued this idea on Wednesday in court. “How many more women have to die?” attorney Erik Baptist asked.In fact, no one dies from mifepristone. One of the most aggressively studied and tested drugs in the world since its creation in France in 1987, mifepristone, which blocks the pregnancy hormone progesterone and stops a pregnancy from progressing, has been found effective and overwhelmingly safe; it has a lower rate of serious complications than Tylenol. One study found that “significant adverse outcomes” occurred in less than 1% (0.65%) of mifepristone patients; the most common of these was continued pregnancy.What women do die from – died from in massive numbers before Roe, and will die from again, if medication abortion becomes unavailable – is illegal surgical abortions.Since Dobbs, the abortion rights movement has correctly been aiming to de-stigmatize illegal, self-managed abortions, encouraging women to stock up on the pills in advance so that they have them if they need them. The idea was that women shouldn’t be scared to use the pills: mifepristone, taken together with the contraction-inducing drug misoprostol, is so overwhelmingly safe and effective that women who could access the pills could confidently and secretly manage their own abortions, even in ban states. But if medication abortion becomes inaccessible, women may attempt more dangerous methods to self-induce. This is the real reason anti-abortion groups are targeting mifepristone: not because it endangers women, but because it keeps them safe.The injunction doesn’t necessarily have to end medication abortion in America as we know it. For one thing, there are already groups, both foreign and domestic, that are mailing abortion medication, including mifepristone, to all 50 states, regardless of local law. Women’s solidarity, inventiveness and determination will always outmatch punitive anti-abortion regimes. For another, an established misoprostol-only protocol for abortion has already been proven effective.Some abortion providers have already signaled their intention to switch to misoprostol-only; the drug is available over the counter in Mexico. But though they are effective, misoprostol-only abortions are also significantly more painful than those conducted with mifepristone. For the anti-abortion groups in court, that’s likely part of the point.
      Moira Donegan is a Guardian US columnist More