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Post by Webster on Mar 26, 2024 14:33:34 GMT -5
(The Guardian) A key moment in the conservative challenge to mifepristone occurred last year, when a federal appeals court issued a ruling to restrict access to the drug. The Guardian’s Melissa Segura reports on the connections between one of the judges who issued that decision, and a group opposing the drug: When the former president Donald Trump appointed the Texas attorney James Ho to the fifth circuit court of appeals in 2017, lawyers at the prominent law firm Gibson Dunn – where Ho worked before his appointment – had a problem: how to replace the politically connected Ho. Turns out, they didn’t even need to change the home address for his replacement. Ho’s wife, Allyson, moved into her husband’s position and his old office.
Meet the Hos.
Few people outside of legal circles have heard of the Hos, yet the couple is tied to the case before the US supreme court that will determine women’s access to mifepristone, a drug commonly used in medication abortions. The court hears arguments in the case on Tuesday.
Ho served on the three-judge panel last summer that ruled to restrict access to mifepristone. The legal group behind the mifepristone case, Alliance Defending Freedom, made at least six payments from 2018 through 2022 to his wife, Allyson, a powerhouse federal appellate lawyer who has argued in front of the supreme court and has deep connections to the conservative legal movement that has led the attack on the right to abortion in the US.
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Post by Webster on Mar 26, 2024 14:34:41 GMT -5
(The Guardian) Supreme court begins hearing conservative challenge to medication abortionThe supreme court has kicked off oral arguments as it weighs a conservative group’s attempt to restrict access to the abortion medication mifepristone. Ruling against mifepristone would 'inflict grave harm on women across the nation' - Biden administration lawyerIn her opening statement, the US solicitor general, Elizabeth Prelogar, asked the supreme court to keep mifepristone available. A ruling in favor of conservative groups challenging the medication “would severely disrupt the federal system for developing and approving drugs, harming the agency and the pharmaceutical industry. It would also inflict grave harm on women across the nation,” Prelogar said. She continued: Rolling back FDA changes would unnecessarily restrict access to mifepristone with no safety justification. Some women could be forced to undergo more invasive surgical abortions, others might not be able to access the drug at all. And all of this could happen at the request of plaintiffs who have no certain injury of their own. The court should reject that profoundly inequitable result.
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Post by Webster on Mar 26, 2024 14:37:30 GMT -5
(The Guardian) The oral arguments began with a debate on whether the doctors have standing, or the right to bring the case in the first place. Anti-abortion doctors claim they will suffer harm if they have to treat women who experience complications from mifepristone, an argument the Biden administration, which appealed the case to the court, has rejected as too speculative, especially given mifepristone’s proven safety record. The supreme court has historically rejected standing arguments based on such potential harm, which the solicitor general, Elizabeth Prelogar, said rested on a “long chain of remote contingencies”. But conservative justices Clarence Thomas and Samuel Alito, both abortion opponents, seemed skeptical of Prelogar’s arguments against standing, with Thomas even suggesting that theories of standing should be reconsidered if they don’t allow the case to move forward. “Is there anybody who can sue and get a judicial ruling on whether what FDA did was lawful?” Alito asked. “Shouldn’t somebody be able to challenge that in court?”
The liberal justice Sonia Sotomayor posed a hypothetical about mifepristone’s safety to Elizabeth Prelogar, the US solicitor general who is defending the government’s handling of the drug. “Even if there is some increase in emergency room visits, the question of when that rises to a sufficient safety risk is up to the” US Food and Drug Administration (FDA), Sotomayor said. “That’s right,” Prelogar replied, and noted that the FDA studied the drug’s safety during the Covid-19 pandemic, when it was even easier to get, and noticed no change in adverse reactions: I also want to emphasize, Justice Sotomayor, that the studies were far from the only evidence FDA consulted at the time it acted in 2021. It had real world experience during the Covid-19 pandemic, a period of time when the in-person dispensing requirement was not enforced. And FDA started by looking at, as a comparative analysis, the two periods of time when you had in-person dispensing and when you didn’t, and saw that there was no relevant increase in serious adverse events or difference between those two timeframes.That’s significant because a federal appeals court last summer ruled against FDA decisions in 2016 and 2021 that made mifepristone easier to access. Those are now being challenged by the government in this hearing.
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Post by Webster on Mar 26, 2024 14:38:15 GMT -5
(The Guardian) The conservative justice Samuel Alito also asked about the role of the Comstock Act, a 19th-century anti-obscenity law that bans the mailing of all abortion-related materials. He suggested that the FDA should have considered the Comstock Act when it changed the rules around the availability of mifepristone, which can now be sent in the mail. Before the overturning of Roe v Wade, the Comstock Act was long regarded as a relic that no longer applied in the modern world. The Biden administration has issued guidance declaring that the Comstock Act only applies in situations where people intend to break the law. However, since Roe fell, anti-abortion activists have tried to argue that Comstock is good law and should block the mailing of at least abortion pills. If the federal government enforced the Comstock Act, it would result in a de facto nationwide abortion ban, because abortion clinics rely so heavily on receiving equipment and other materials through the mail to perform abortions.
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Post by Webster on Mar 26, 2024 14:42:01 GMT -5
(The Guardian) Ruling in favor of abortion foes would threaten 'virtually every drug approval', attorney for mifepristone maker warnsUp now before the supreme court is Jessica Ellsworth, an attorney for Danco Laboratories, which manufactures mifepristone. She warned the justices that if they allowed anti-abortion doctors’ challenge to mifepristone to stand, it could have unpredictable ripple effects across the pharmaceutical industry: Respondents’ view of the Food Drug and Cosmetic Act is so inflexible it would upend not just mifepristone, but virtually every drug approval … FDA has made for decades.Ellsworth argued that “respondents lack standing under every prong of the analysis”, and added that the FDA “exhaustively” studied the drug to ensure it’s safe.
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Post by Webster on Mar 26, 2024 14:42:48 GMT -5
(The Guardian) Justice Samuel Alito’s question about complications from mifepristone goes to the heart of why the medical and pharmaceutical industry considers it so scary for judges to decide questions of science. Alito asked whether the Food and Drug Administration (FDA) shouldn’t have provided a more extensive explanation of why telehealth prescribing of mifepristone could lead to an increase in emergency room visits. “The increase in ER visits is just of no consequence? It doesn’t even merit some comment?” Alito asked Elizabeth Prelogar, the US solicitor general. Defending the FDA, Prelogar said: “It fully explained its decision-making and I think it falls well within the realm of reasonableness.” To researchers, the FDA comment in question made an obvious point: an increase in emergency room visits does not denote greater risk for adverse events. An emergency room visit is a proxy measure – in other words, it might indicate the possibility of adverse events, but it may also indicate only an increase in women seeking reassurance, particularly in connection with a drug like mifepristone, which induces bleeding. This is exactly the kind of complicated parsing of science that the FDA considers every day when looking at studies on the safety and efficacy of drugs.
Now arguing before the court is Erin Hawley, who represents the anti-abortion Alliance for Hippocratic Medicine. In her opening arguments to the justices, she characterized mifepristone as posing risks that the FDA has not done enough to manage. “The lower court’s decision merely restored longstanding and crucial protections under which millions of women used abortion drugs,” she said, referring to earlier rulings in the case. “That respondent doctors will be forced to manage abortion drug harm is not a bug in FDA system, but part of its very design.”
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Post by Webster on Mar 26, 2024 14:43:43 GMT -5
(The Guardian) Justice Ketanji Brown Jackson gave Danco’s lawyer Jessica Ellsworth some air to explain why pharmaceutical companies have lined up in opposition to undermining the FDA’s authority. “Do you have concerns about judges parsing medical and scientific studies?” Jackson asked. Ellsworth, the lawyer for the manufacturer of mifepristone, said pharmaceutical companies have “significant concerns” and rely on the “FDA’s gold standard review process”. “The reality is … you have a district court that, among other things, relied on one study that was an analysis of anonymous blog posts,” said Ellsworth. Other studies “have since been retracted for lack of scientific rigor and misleading data”. Precisely because judges are not experts in statistics and the methodologies used for studies in clinical trials – that is why FDA has many hundreds of pages of analysis in the record of what the scientific data showed, and courts are just not in a position to parse and second-guess” that, she said.
The arguments have repeatedly returned to the question of emergency abortions and the role of a federal law known as the Emergency Medical Treatment and Active Labor Act, or Emtala, which broadly requires hospitals to stabilize patients who are facing medical emergencies rather than turning them away. Erin Hawley, a lawyer representing the Alliance for Hippocratic Medicine, has said that in emergency situations, the anti-abortion doctors she represents do not have the time or ability to turn down cases that involve complications from abortions -even though working on such a case could run counter to their objections to abortion. (More than 100 studies have concluded that mifepristone is a safe and effective way to end a pregnancy.) Solicitor general Elizabeth Prelogar, however, has contended that hospitals prepare and protect doctors from being forced to work on cases to which they object. “The federal government has never taken the position that Emtala would override an individual doctor’s conscience objections,” she said. As for Emtala, the court will turn to that law next month, when the justices consider if it requires doctors to perform emergency abortions. Oral arguments are set for 24 April.
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Post by Webster on Mar 26, 2024 14:44:32 GMT -5
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Post by Webster on Mar 26, 2024 14:45:14 GMT -5
(The Guardian) The just-concluded supreme court arguments over mifepristone were a deep dive into the technicalities of how the US government approves and regulates medication. The Guardian’s Carter Sherman has taken a close look at what the case entails, and when the nation’s highest court may rule: Less than two years after it overturned Roe v Wade and ended the national right to abortion, the US supreme court is back on the frontlines of the American abortion wars.
On Tuesday, the court will hear oral arguments in one of the most highly watched cases of the session, which could dramatically curtail access to mifepristone, a drug typically used in medication abortions. The court is reviewing decisions made by the Food and Drug Administration (FDA) to loosen restrictions on the drug, such as allowing non-physicians to prescribe it, as well as letting providers prescribe it through telehealth rather than in-person appointments.
Any decision to restrict mifepristone will affect everyone in the US, not only those who live in the 16 states that have banned nearly all abortions. This case could also have wide-ranging consequences for the FDA’s future decision-making. A decision from the nation’s highest court in the case will probably arrive by summer 2024.
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Post by Webster on Mar 27, 2024 13:31:26 GMT -5
(The Guardian) In surprise victory, Democrat wins state House seat in deep red Alabama after campaign focused on reproductive rightsLast night, Democrats in Alabama did something they do not often do in the deeply conservative state: win a seat in the state house of representatives back from the GOP. And how they did it may be a sign of what we can expect to work with voters nationwide as Joe Biden stumps for a second term while trying to gain complete control of Congress in November. In the case of Alabama, the Democrat Marilyn Lands campaigned on repealing Alabama’s strict abortion ban and fully restoring access to in vitro fertilization, the fertility treatment that the Alabama supreme court briefly outlawed last month. Lands lost the race for the seat in the swing district just two years ago, but in last night’s special election triumphed with a more than 25% margin over the Republican candidate. Why does this all matter? For Democrats, it’s the latest sign that voters remain uncomfortable with the implications of the supreme court’s 2022 decision overturning Roe v Wade, and those objections can be harnessed to make inroads even in the most inhospitable terrain, like Alabama. Whether Biden and his allies can repeat the act just over seven months from now is an open question. Democrats and Biden campaign cheer surprise special election victory in AlabamaJust how did Marilyn Lands end up ousting Republicans from a suburban state house seat in northern Alabama? The Associated Press reports that the licensed counselor’s pitch to voters included the following demands: “Our legislature must repeal Alabama’s no-exceptions abortion ban, fully restore access to IVF, and protect the right to contraception.” Voters liked what they heard, and so did the Democratic party at large. Here’s what chair Jaime Harrison had to say about Lands’s victory: Today’s election – one of the first since the devastating decision by the Alabama supreme court that stopped IVF care – was a referendum on Maga Republicans’ out-of-touch extremism on reproductive rights. Marilyn Lands’ victory demonstrates that voters aren’t going to sit idly by while Maga Republicans lay the groundwork for a national abortion ban.And Julie Chavez Rodriguez, manager of Joe Biden’s re-election campaign: Last month, Alabamans lost access to fertility treatments because of Donald Trump. Tonight, the voters in Alabama’s 10th house district elected a pro-choice champion in Marilyn Lands, sending Trump and extreme Maga Republicans a clear message: they know exactly who’s to blame for restricting their ability to decide how and when to build their families and they’re ready to fight back. Trump overturned Roe vWade, paving the way for attacks on women’s freedoms like we saw in Alabama – now he’s running to ban abortion and gut access to IVF nationwide. Tonight’s results should serve as a major warning sign for Trump: voters will not stand for his attacks on reproductive healthcare. This November will be no different.
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Post by Webster on Mar 27, 2024 13:34:47 GMT -5
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Post by Webster on Mar 27, 2024 13:35:43 GMT -5
(The Guardian) Reproductive rights were also on the minds of the supreme court justices yesterday, when they considered a challenge by a conservative group to abortion medication mifepristone. But while many of the justices who heard the case voted to overturn Roe v Wade, the Guardian’s Carter Sherman and Jessica Glenza report they don’t appear inclined to take similar action against medication abortion: A US supreme court hearing that held the potential to reshape abortion access and the US Food and Drug Administration’s authority did not go well for anti-abortion doctors behind the case, legal experts said on Tuesday.
The consensus is a positive sign for abortion-rights advocates, who feared the case would curtail access to medication abortions, which now account for the majority of all abortions nationally.
“It’s very possible that they will just toss the lawsuit out because the anti-abortion doctors didn’t have legal standing to sue,” said Lawrence Gostin, a professor at Georgetown Law School and an expert in global public health law, said about the justices. “In my view, the lawsuit was absurd on its face and deserves to be thrown out because these anti-abortion doctors had very little injury,” Gostin added.
The case deals with FDA regulation of the drug mifepristone, one-half of a two-drug regimen used to terminate an early pregnancy. A group representing the doctors, called the Alliance for Hippocratic Medicine, has sought to roll back FDA decisions that expanded mifepristone access, such as allowing doctors to prescribe it via telehealth.
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Post by Webster on Apr 2, 2024 15:34:59 GMT -5
(The Guardian) Democrats look to turn up heat on GOP after Florida court authorizes six-week abortion banDemocrats have not had much luck in Florida lately, where its status as a swing state has been eroded by years of Republican victories. And the GOP once again got their way yesterday when a court allowed a six-week abortion ban signed by governor Ron DeSantis to take effect in 30 days. But voters in many states, even those otherwise hostile to Democrats, have signaled that they are not on board with efforts to tighten access to the procedure, and today, Joe Biden’s campaign and its allies are seizing on the Florida ruling to argue it is a sign of what Donald Trump would do if returned to the White House and perhaps regain some momentum in Florida. At 10am ET, Hakeem Jeffries, the Democratic House minority leader, Xavier Becerra, the health and human services secretary, and other lawmakers will hold a hearing in Broward county on threats to productive freedom, while the Biden-Harris campaign is convening a call between reporters and North Carolina governor Roy Cooper to elaborate on the message. Biden condemns Florida court's 'extreme decision' that will allow six-week abortion ban to take effectJoe Biden decried yesterday’s Florida court ruling that sets the stage for the state’s six-week abortion ban to take effect, calling it “outrageous” and warning women’s health will suffer. “Yesterday’s extreme decision puts desperately needed medical care even further out of reach for millions of women in Florida and across the South,” Biden said. “The Court not only upheld Florida’s current ban on women being able to make their own reproductive choices, it will likely trigger Governor DeSantis’ even more extreme law that would prevent women from accessing care before many even know they are pregnant. It is outrageous.” He continued: Florida’s bans – like those put forward by Republican elected officials across the country – are putting the health and lives of millions of women at risk. These extreme laws take away women’s freedom to make their own health care decisions and threaten physicians with jail time simply for providing the medical care that they were trained to provide.
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Post by Webster on Apr 2, 2024 15:39:51 GMT -5
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Post by Webster on Apr 2, 2024 15:47:47 GMT -5
(The Guardian) Democratic senator announces plan to repeal 19th century law that could stop abortion nationwideDemocratic senator Tina Smith announced she is leading an effort to repeal the Comstock Act, a federal anti-obscenity law passed in 1873 that abortion rights supporters fear could be used to ban the procedure nationwide. While the Biden administration considers the act irrelevant, it remains in force and includes language that could criminalize the mailing of abortion medication such as mifepristone, or drugs used in surgical abortion. The concern is that a future president who opposes abortion, like Donald Trump, could decide to enforce the statute to criminalize abortion even in states that allowed the procedure to continue after Roe v Wade was overturned. “Legislation to repeal Comstock could take many forms, and we need to do it the right way. That’s why I’ve begun reaching out to my colleagues in the House of Representatives and the Senate to build support and see what legislation to repeal the Comstock Act might look like,” wrote Smith, who represents Minnesota, in the New York Times. “Anti-abortion extremists will continue to exploit any avenue they can find to get the national ban they champion, and I want to make sure my bill shuts down every one of those avenues. Once the Supreme Court has had its say (and many legal analysts speculate that the mifepristone case heard last week should be thrown out on procedural grounds, and may well be), I’ll be ready to have mine.”
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