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.
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.
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?”
Ruling against mifepristone would 'inflict grave harm on women across the nation' - Biden administration lawyer
In 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.
Supreme court begins hearing conservative challenge to medication abortion
The supreme court has kicked off oral arguments as it weighs a conservative group’s attempt to restrict access to the abortion medication mifepristone.
Arguments are expected to take an hour. We’ll be covering them live.
As we await the start of the supreme court’s oral arguments in the conservative challenge to abortion medication mifepristone, here’s the Guardian’s Carter Sherman with a rundown of what we can expect in today’s hearing:
Abortion is back at the US supreme court, with arguments on Tuesday in the first major case on the issue since a 6-3 majority ruled in 2022to overturn Roe v Wade and endthe national right to abortion– a decision that unleashed abortion bans throughout the country as well asa political backlash that Democrats hope will serve them in the coming presidential election.
At issue in the case is the future of mifepristone, adrug typically used in US medication abortions. The rightwing groups that brought the case are seeking to roll back measures taken by the Food and Drug Administration (FDA) to expand the drug’s availability in recent years.
A decision in their favor would apply nationwide, including in states that protect abortion access, and would likelymake the drug more difficult to acquire. The loosening of restrictions on mifepristone have helped mitigate the impact of post-Roe abortion bans; if those restrictions are reimposed, abortion rights groups anticipate it will become significantly more difficult to access abortions in the US.
“More than 60% of abortions in the US are medication abortions, so that would impact a substantial number of people, whether you live in a protective state or a restricted state,” said Nicole Huberfeld, a health law professor at Boston University’s School of Public Health.
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.
A speaker who said they are with Alliance for Defending Freedom is speaking to a collection of antiabortion activists holding signs that say “FDA do your job” pic.twitter.com/d9p3Xc15tE
Ruling tightening mifepristone access could upend US pharmaceutical industry
It’s not just access to medication abortion that could be upended by a supreme court ruling tightening access to mifepristone. As the Guardian’s Jessica Glenza reports, the conservative challengers to the drug have targeted decisions made by the US Food and Drug Administration (FDA) to make it easier to prescribe.
But if the supreme court agrees with their complaint, it opens up the possibility of a wave of challenges to other medications that treat a range of issues. Doctors and pharmaceutical companies have become so concerned about the case that they have filed briefs defending the FDA against the conservative challenge.
Here’s more on why the stakes in the case are so high:
A supreme court case about one little pill – mifepristone – has the medical and pharmaceutical world on edge. The pill, at the heart of a case that will be argued on Tuesday, is part of a two-drug regimen used to treat miscarriage and end early pregnancies.
Despite a more than 20-year track record of safe real-world use, backed up by more than 100 peer-reviewed studies, a group of anti-abortion doctors is seeking to roll back US Food and Drug Administration (FDA) decisions that changed and relaxed some prescribing rules.
If the doctors succeed, despite contested and in some cases now-retracted evidence of harm, the case could reshape abortion access in the US and have enormous and unpredictable consequences for how drugs are prescribed, regulated and developed.
A ruling in favor of anti-abortion doctors could threaten everything from trust in medicine to specific drugs to the US’s position as the world’s foremost drug innovator.
“I am terrified,” said Juan Hincapie-Castillo, a drug policy researcher, licensed pharmacist and assistant professor of epidemiology at the University of North Carolina. “This case is shifting the whole paradigm of how things could go moving forward”.
Mifepristone was approved by the FDA in 2000 with stringent requirements for how it should be prescribed: only up to seven weeks gestation, dispensed in-person with mandatory follow-up appointments, and with enhanced risk-reporting requirements for doctors. Along with misoprostol, the second drug in the regimen, it is, in effect, designed to induce the equivalent of a miscarriage at home.
After more than 20 years and scientific articles spanning 26 countries, the scientific consensus is that the “abortion pill” has a remarkable track record of safety and effectiveness that, in the media, is often compared to that of Tylenol or Viagra.
But following the fall of Roe v Wade in 2022, anti-abortion doctors initiated a lawsuit against the FDA in Amarillo, Texas, arguing that the drug’s approval should be withdrawn. The Trump-appointed judge Matthew Kacsmaryk ruled in favor of the doctors. Were his decision not appealed, it would have resulted in a de facto nationwide ban on medication abortion.
Supreme court to weigh conservative challenge to key abortion pill mifepristone
Good morning, US politics blog readers. Nearly two years after overturning Roe v Wade and allowing states to ban abortion, the supreme court will today at 10am ET hear arguments in a case that could limit the availability of the abortion pill mifepristone. It’s the first time the justices will address reproductive rights since the Dobbs decision in 2022, and will be argued before a court that is ideologically quite similar to the one that decided that case. Conservative justices, including the same five who voted to strike down Roe, dominate the court with a six-seat majority, while liberals hold a three-seat minority.
The arguments come as evidence emerges that usage of abortion medication has soared among Americans. A decision limiting access to mifepristone could also cause tumult in the presidential race, and is sure to be seized on by Joe Biden to argue that it’s a sign of what Donald Trump would do if put back in the White House. Trump did, after all, appoint three justices to the court and tip it decisively to the conservatives – all of whom voted to overturn Roe.
Here’s what else is going on today:
Joe Biden has been briefed on the collapse of the Francis Scott Key Bridge in Baltimore. We have a live blog covering the latest news on the disaster, and you can find it here.
Is the GOP surrendering in their push to impeach Biden? Reports have emerged that the Republican architect of the attempt to bring charges against the president now says he’ll settle for a criminal referral to the justice department.
The White House press briefing will take place on Air Force One as Biden heads to campaign in North Carolina, sometime after 1pm.
