Roe v Wade
Subterms
More stories
- in US Politics
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 US Politics
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
- in US Politics
US appeals Texas judge’s ruling to suspend abortion pill approval
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
- in US Politics
Wyoming becomes first US state to outlaw use of abortion pills
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
- in US Politics
The right is stealthily working to remove Americans’ access to abortion medication | Moira Donegan
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 - in US Politics
Republicans push wave of bills that would bring homicide charges for abortion
Republicans push wave of bills that would bring homicide charges for abortionProliferation of bills in Texas, Kentucky and elsewhere ‘exposes fundamental lie of anti-abortion movement’, experts sayFor decades, the mainstream anti-abortion movement promised that it did not believe women who have abortions should be criminally charged. But now, Republican lawmakers in several US states have introduced legislation proposing homicide and other criminal charges for those seeking abortion care.‘Sanctuary cities for the unborn’: how a US pastor is pushing for a national abortion banRead moreThe bills have been introduced in states such as Texas, Kentucky, South Carolina, Oklahoma and Arkansas. Some explicitly target medication abortion and self-managed abortion; some look to remove provisions in the law which previously protected pregnant people from criminalization; and others look to establish the fetus as a person from the point of conception.It is highly unlikely that all of these bills will pass. But their proliferation marks a distinct departure from the language of existing bans and abortion restrictions, which typically exempt people seeking abortion care from criminalization.“This exposes a fundamental lie of the anti-abortion movement, that they oppose the criminalization of the pregnant person,” said Dana Sussman, the acting executive director of Pregnancy Justice. “They are no longer hiding behind that rhetoric.”Some members of the anti-abortion movement have made it clear the bills do not align with their views, continuing to insist that abortion providers, rather than pregnant people themselves, should be targeted by criminal abortion laws.“[We] oppose penalties for mothers, who are a second victim of a predatory abortion industry,” said Kristi Hamrick, the chief media and policy strategist for Students for Life of America. “We want to see a billion-dollar industry set up to profit by preying on women and the preborn held accountable. The pro-life movement as a whole has been very clear on this.”A spokesperson for Susan B Anthony Pro-Life America echoed the same sentiment: that the organization unequivocally rejects prosecution of the pregnant person.The bills are likely to be controversial as they proceed, even within conservative circles: Republicans have frequently hit walls when trying to pass anti-abortion legislation, with lawmakers at odds over exactly how far bans should go.The reproductive justice organization If/When/How points out these bills are an indication of the different wings and splinter groups in the anti-abortion movement, increasingly evident since the Dobbs decision last year that overturned Roe v Wade.“What we’re seeing, post-Dobbs, is a splintering in tactics that abortion opponents are using, and emboldening on the part of more hardline” factions within the movement, said Farah Diaz-Tello, senior counsel and legal director at If/When/How.“That has always been an undercurrent” in the movement, Diaz-Tello added. “As we see other abortion opponents declaring their opposition to criminalization of people who end their pregnancies, this is the opportunity for them to really step up and put those principles into action.”The bills being introduced in Arkansas, Texas, Kentucky and South Carolina look to establish that life begins at conception. Each of these bills explicitly references homicide charges for abortion. Homicide is punishable by the death penalty in all of those states.Bills in Oklahoma, South Carolina and Texas also explicitly target medication abortion, which so far has fallen into a legal grey zone in much of the country.A bill in Alabama has also been announced, although not yet been introduced, by Republican representative Ernest Yarbrough, that would establish fetal personhood from conception and repeal a section of Alabama’s abortion ban that expressly prevents homicide charges for abortion. The state’s current law makes abortion a class A felony, on the same level as homicide, but exempts women seeking abortions from being held criminally or civilly liable.Laws that establish fetal personhood also bring the risk of opening pregnant people up to battery and assault charges for endangering a fetus. Such charges have already been documented in hundreds of cases, using criminal laws championed in recent decades by the anti-abortion movement that recognize fetuses as potential victims.“It never starts or stops with abortion,” said Sussman of the far-reaching effects of fetal personhood laws.“That means that not getting prenatal care, not taking pre-natal vitamins, working a job that is physically demanding – all of those things could impose some risk to the fetus – and that could be a child neglect or child abuse case.”Such laws have been used to target pregnant people who have taken prescribed medication, taken illegal drugs or drunk alcohol while pregnant, even when there has been no adverse outcome on the fetus.Some of the bills, such as the one in Arkansas, allow a partner to file an unlawful death lawsuit against a pregnant person who has had an abortion.“The ways in which pregnant people could become a mere vessel for an entity that has separate and unique rights is becoming closer and closer to reality. And there are ways in which this could be used that we haven’t even contemplated yet,” said Sussman.TopicsUS newsAbortionLaw (US)Reproductive rightsRoe v WadeUS politicsnewsReuse this content More
