More stories

  • in

    North Dakota governor signs law banning nearly all abortions

    North Dakota on Monday adopted one of the strictest anti-abortion laws in the US as the Republican governor Doug Burgum signed legislation banning the procedure throughout pregnancy, with slim exceptions up to six weeks’ gestation.In those early weeks, abortion would be allowed only in cases of rape, incest or medical emergency, such as ectopic pregnancy.“This bill clarifies and refines existing state law … and reaffirms North Dakota as a pro-life state,” Burgum said in a statement.Last year’s US supreme court ruling overturning the 1973 Roe v Wade decision that legalized abortion nationwide has triggered multiple state laws banning or restricting the procedure. Many were met with legal challenges. Currently, bans on abortion at all stages of pregnancy are in place in at least 13 states and on hold in others because of court injunctions. On the other side, Democratic governors in at least 20 states this year launched a network intended to strengthen abortion access in the wake of the supreme court decision that eliminated women’s constitutional right to end a pregnancy and shifted regulatory powers over the procedure to state governments.The North Dakota law is designed to take effect immediately, but last month the state supreme court ruled a previous ban is to remain blocked while a lawsuit over its constitutionality proceeds. Last week, lawmakers said they intended to pass the latest bill as a message to the state’s high court signaling that the people of North Dakota want to restrict abortion.Supporters have said the measure signed Monday protects all human life, while opponents contend it will have dire consequences.North Dakota no longer has any abortion clinics. Last summer, the state’s only facility, the Red River Women’s Clinic, shut its doors in Fargo and moved operations a short distance across the border to Moorhead, Minnesota, where abortion remains legal. The clinic’s owner is still pursuing a lawsuit challenging the constitutionality of North Dakota’s previous abortion ban.It’s expected that this new ban will also be the subject of legal challenges.Republican Senator Janne Myrdal, of Edinburg, sponsored the latest state legislation.“North Dakota has always been pro-life and believed in valuing the moms and children both,” Myrdal said in an interview. “We’re pretty happy and grateful that the governor stands with that value.”Liz Conmy, a Democratic representative, voted against the bill and said she had hoped Burgum would not sign it.“I don’t think women in North Dakota are going to accept this and there will be action in the future to get our rights back,” Conmy said. “Our legislature is overwhelmingly pro-pregnancy, but I think women in the state would like to make their own decisions.” More

  • in

    Republican Graham loses cool over abortion after supreme court pill ruling

    Republican frustration with the supreme court decision which on Friday blocked restrictions on a widely used abortion pill spilled into public on Sunday, as the South Carolina senator Lindsey Graham lost his cool in a television interview when challenged on his flip-flopping position.Graham, who last September proposed a national 15-week abortion ban only a month after insisting it was an issue for states to decide, became angry on CNN’s State of the Union, deflecting questions with false claims Democrats wanted a law allowing abortions until birth on demand.The flustered senator accused his interviewer, Dana Bash, of covering for opponents he said wanted to see “barbaric” late-term abortions “out of line with the rest of the civilised world” and commonplace, he said, only in China and North Korea.“No, no, no, you [in the] media keep covering for these guys,” Graham shouted. “They introduced legislation that allowed abortion on demand with taxpayer funds to the moment of birth, that’s the law they want to pass and nobody in your business will talk about it.”Bash replied she was covering for nobody and had frequently challenged Democrats on the issue.The official position of the Democratic party is to codify federal protections for abortion, guaranteed by the Roe v Wade decision of 1973 until overturned by the supreme court last year, that permitted the procedure until “fetal viability”, generally accepted to be at about 24 weeks’ gestation.The spectacle of Graham’s anger underscored how Republicans are struggling to find a cohesive response to Friday’s ruling over the abortion pill mifepristone and on abortion in general.Many analysts and party members believe the issue cost votes in last year’s midterms, following the supreme court Dobbs v Jackson ruling that overturned Roe v Wade.Moves by several Republican-led states to tighten abortion restrictions, including the signing by the Florida governor, Ron DeSantis, of the nation’s most extreme ban, at six weeks, have prompted voter backlash. Polling shows three in five Americans approve of abortion access in most or all cases.On ABC’s This Week, the South Carolina Republican congresswoman Nancy Mace said the court was right to block restrictions last month placed on mifepristone by a Texas judge appointed by Donald Trump.“This was a hand-picked case with a hand-picked judge to get this outcome,” she said. “And when you look at the ruling in Texas, in part at least, it used a law that the supreme court in 1983 said was unconstitutional.“So the basis for his ruling, I argue, was debunked and it should not have been.”Mace, who has spoken of being raped as a teenager, said the approach of her party to the wider issue was too rigid, and colleagues needed to show more sympathy and compassion for victims of rape who found it difficult or impossible to obtain an abortion.“I want us to find some middle ground,” she said. “As a Republican and conservative, a constitutional conservative who’s pro-life, I saw what happened after Roe v Wade [fell] … I saw the sentiment change dramatically.“As Republicans, we need to read the room because the vast majority of folks are not in the extremes. We just saw a fetal heartbeat bill signed in the dead of night in Florida. In my home state a very small group of state legislators filed a bill that would execute women who have abortions and gave more rights to rapists than women who have been raped.“That is the wrong message heading into 2024. We’re going to lose huge if we continue down this path of extremities. It hurt us in the midterms. We actually lost seats. We’ve buried our heads in the sand. We want to go to the extreme corners of this issue, but that’s not where the vast majority of Americans are right now.”Amy Klobuchar, a Democratic senator for Minnesota and a leading voice for abortion rights, also hailed the mifepristone decision.“Senator Graham knows where the American people are on this,” she told CNN. “They are with Democratic leaders, and the people of this country believe that the women of this country should be able to make their own decisions about their healthcare and not politicians.”Klobuchar also attacked the legal arguments advanced by those seeking to ban mifepristone, which in part relied on the 150-year-old Comstock Act prohibiting the mailing of contraceptives, “lewd” writings and any “instrument, substance, drug, medicine, or thing” that could be used in an abortion.The law has not been enforced since the 1930s, according to NPR.“It was literally passed in 1873,” Klobuchar said. “That is 10 years before the Yellowstone prequel, at a time when we were treated for pneumonia through bloodletting, back in the age of the Pony Express.“The American people do not want to go backwards. And what I heard today is that Republican leaders in Washington aren’t backing down on their opposition to reproductive freedom. They are doubling down.” More

  • in

    US supreme court blocks ruling limiting access to abortion pill

    The supreme court decided on Friday to temporarily block a lower court ruling that had placed significant restrictions on the abortion drug mifepristone.The justices granted emergency requests by the justice department and the pill’s manufacturer, Danco Laboratories, to halt a preliminary injunction issued by a federal judge in Texas. The judge’s order would significantly limit the availability of the medication as litigation proceeds in a challenge by anti-abortion groups.The decision offered a victory to the Biden administration as it defends access to the drug in the latest fierce legal battle over reproductive rights in the US. The president praised the decision and said he continues to stand by the FDA’s approval of the pill.“As a result of the supreme court’s stay, mifepristone remains available and approved for safe and effective use while we continue this fight in the courts,” Biden said in a statement. “The stakes could not be higher for women across America. I will continue to fight politically driven attacks on women’s health.”The court’s ruling means that access to mifepristone will remain unchanged at least into next year as appeals play out and patients can still get medication abortions with the drug in states where it was previously available.Reproductive rights groups celebrated the ruling, while cautioning it does not necessarily herald the final outcome of the case. “This is very welcome news, but it’s frightening to think that Americans came within hours of losing access to a medication that is used in most abortions in this country and has been used for decades by millions of people to safely end a pregnancy or treat a miscarriage,” said Jennifer Dalven, director of the Reproductive Freedom Project at the American Civil Liberties Union. “Make no mistake, we aren’t out of the woods by any means. This case, which should have been laughed out of court from the very start, will continue on.”The decision came in the most pivotal abortion rights case to make its way through the courts since Roe v Wade was overturned last year. More than half of abortions in the US are completed using pills.The case was brought by a conservative Christian legal group arguing the Food and Drug Administration improperly approved mifepristone more than 23 years ago.The Biden administration vigorously defended the FDA against the charge, emphasizing its rigorous safety reviews of the drug and the potential for regulatory chaos if plaintiffs and judges not versed in scientific and medical arguments begin to undermine the agency’s decision-making.Conservative justices Clarence Thomas and Samuel Alito dissented, with Alito writing that the Biden administration and Danco “are not entitled to a stay because they have not shown that they are likely to suffer irreparable harm in the interim”.The order granting the stay was unsigned, so it is not known how each of the other seven justices voted.The case has moved quickly through the courts in recent weeks, as contradicting rulings have thrown the future of the drug into question.In early April, a federal judge in Texas, Matthew Kacsmaryk, first ruled in the lawsuit brought by a coalition of anti-abortion groups to suspend the FDA’s 23-year-old authorization of mifepristone entirely, writing that the agency wrongly approved the drug. After a challenge by the Biden administration in the fifth circuit court of appeals, a divided three-judge panel said the drug’s approval could stand, but imposed restrictions on it, limiting its use to seven weeks of pregnancy instead of the current 10-week limit, and banning delivery of the pill by mail.The Biden administration then asked the supreme court to intervene before the restrictions went into effect. Alito twice stayed the lower court ruling, keeping access to mifepristone unaltered while the court deliberated.Complicating matters, another federal judge issued a ruling directly contradicting Kacsmaryk’s, ordering the FDA to refrain from making any changes to the availability of mifepristone in 18 jurisdictions.That judge – Judge Thomas O Rice, in Washington – reaffirmed that order after the fifth circuit’s ruling.Both the Biden administration and pharmaceutical companies have warned of regulatory chaos around drug approvals, should the supreme court allow the restrictions on mifepristone to go into effect.“If this ruling were to stand, then there will be virtually no prescription, approved by the FDA, that would be safe from these kinds of political, ideological attacks,” president Biden said in a written statement after the Kacsmaryk’s decision in early April.The US vice-president, Kamala Harris, echoed the point in a statement responding to the appellate decision: “If this decision stands, no medication – from chemotherapy drugs, to asthma medicine, to blood pressure pills, to insulin – would be safe from attacks.” More

  • in

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

    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

  • in

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

    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

  • in

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

    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