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Mifepristone ruling – latest: Supreme Court decision keeps medical abortion pill approval in place

The nation’s highest court will weigh in on a challenge to the FDA’s approval of the drug

Alex Woodward
Saturday 22 April 2023 15:19 BST
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(AFP via Getty Images)

The US Supreme Court has kept the government’s approval of a widely used abortion drug in place, while one of the biggest battles over abortion rights since the end of Roe v Wadecontinues in federal courts.

Justices on the nation’s highest court have paused a lower court ruling that challenge the government’s 23-year-old approval of mifepristone, part of a two-drug protocol for medication abortion, the most common form of abortion in the US.

Following an appeal from the Biden administration and drugmakers, the court paused a federal judge’s ruling that would strip the US Food and Drug Administration’s approval of mifepristone, which was first approved by the government agency in 2000.

A ruling to strike down the FDA’s approval of the drug would have drastically impacted access to abortion and miscarriage care for millions of Americans across the country, including in states where it is legally protected.

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Texas judge behind abortion drug ruling didn’t disclose radio interviews where he said being gay was ‘a lifestyle’

The federal judge who suspended the US Food and Drug Administration’s approval of the abortion pill mifepristone failed to disclose two interviews where he discussed contraception and gay rights, CNN reported.

Matthew Kacsmaryk, a judge on the US District Court for the Northern District of Texas, made the remarks in two interviews with the Chosen Generation, a show that bills itself as having a “biblical constitutional worldview.”

The report follows revelations that Mr Kacsmaryk also failed to disclose to members of Congress that he authored an article attacking abortion rights and transgender healthcare in a right-wing legal journal.

Texas abortion judge didn’t disclose interviews calling being gay ‘a lifestyle’

The judge who blocked the FDA’s authorisation of mifepristone says he did not recall the interivew

Alex Woodward21 April 2023 15:30
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Ohio lawmaker shuts down anti-abortion activist who attacked mother of 10-year-old rape victim

An Ohio state representative had sharp words for an anti-abortion advocate who made false claims about the now-infamous case of a 10-year-old from the state who had to travel to Indiana to receive an abortion after being raped because of Ohio’s near-total ban on the procedure.

Watch the exchange:

Ohio rep shuts down anti-abortion campaigner who attacked child rape victim’s OB-GYN

Child had to travel to Indiana for an abortion because of her home state’s near-total ban

Alex Woodward21 April 2023 16:00
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The first-ever testimony to Congress showing how to use abortion pills

Last year, as members of Congress held committee hearings about the aftermath of a decision to strike down Roe v Wade, several witnesses gave powerful testimony about their abortion experiences and the often complicated healthcare systems they had to navigate.

Renee Bracey Sherman, the founder of We Testify, which highlights stories from people who have had abortions, explained the regimen for medication abortion – the two-drug protocol that is overwhelmingly the most common form of abortion care.

It appeared to be the first time ever that a witness in Congress explained how to take abortion drugs.

Watch her testimony:

Witness tells Congress how to self-manage abortion with pills in powerful testimony

Renee Bracey Sherman’s powerful, personal testimony appears to be the first ever in the US Capitol explaining how to use abortion pills outside of a traditional medical setting

Alex Woodward21 April 2023 16:30
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What is the Comstock Act and why is it involved in this case?

A puritanical Civil War-era federal law that sought to ban the mailing of “lewd” or “obscene” material is referenced in an anti-abortion activist group’s legal challenge to mifepristone that is now in front of the US Supreme Court.

The law has been repeatedly undermined by other laws and in the courts but it remains on the books, exploited by anti-abortion activists who are now using the law to argue why it is technically illegal to mail abortion drugs.

The US Department of Justice disputes that argument. Pharmacists or other providers who mail mifepristone have no idea whether it will be used illegally, and the medicine is also used in miscarriage care. Mifepristone was approved for use 23 years ago, and can be taken up to 10 weeks of pregancy, when the vast majority of abortions are performed. The drug is used similarly in dozens of countries.

But US District Judge Matthew Kacsmaryk argued that the Comstock Act forbids mailing abortion drugs. A three-judge panel at a federal appeals court also appeared to agree.

Mary Ziegler, a law professor at the University of California, Davis and an expert on reproductive health law, said anti-abortion activists have intentionally relied on the law as part of a broader strategy to criminalise abortion care,

“Because if you can prosecute anyone for putting anything in the mail related to abortion, there is no abortion in the United States that takes place without something put in the mail,” she told NPR. “There are no abortion providers making DIY drugs and medical devices.”

(AP)
Alex Woodward21 April 2023 17:00
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How the Supreme Court could act, according to an expert

Steve Vladeck, a University of Texas School of Law professor and keen observer of the nation’s high court, suggests a handful of scenarios from an imminent decision from the justices in the mifepristone case:

The court would either continue pausing a federal judge’s decision to block the FDA’s approval of the drug or allow the ruling to stand while the case continues to play out in the appeals court. The Supreme Court could also issue a mixed ruling, or issue no ruling at all. The justices might also kick the can down the road a second time, though that is unlikely.

Anything but the first option could have major impacts to mifepristone access, and providers and clinics are bracing for a scenario where they no longer will be able to acquire the drug.

“One way or the other, I expect that we get something from the full Court today — although *when* and *what* is anyone’s guess,” Vladeck said.

Alex Woodward21 April 2023 17:34
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The states stockpiling mifepristone

Several Democratic-led states are boosting their supplies of mifepristone and protecting providers from criminal prosecution ahead of potential threats to the abortion drug’s access.

California has secured an “emergency” stockpile of misoprostol, which is used in medication abortion procedures along with mifepristone. Abortion providers across the US are also considering misoprostol-only abortion care if mifepristone’s access is limited.

Massachusetts Governor Maura Healy directed the University of Massachusetts and providers to buy $15,000 doses of mifepristone.

New York Governor Kathy Hochul said the state has a five-year supply of misoprostol on hand.

Oregon Governor Tina Kotek announced on Thursday that the state is working with Oregon Health and Science Universityto secure 22,500 doses of mifepristone, a three-year supply.

Washington Governor Jay Inslee also said the state purchased a three-year supply of mifepristone through the state’s Department of Corrections, which has a pharmacy license.

Alex Woodward21 April 2023 18:00
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What is mifepristone? And why does it matter if the FDA’s approval is revoked?

A ruling to strip a commonly used abortion drug of its FDA’s approval could mean that its availability would violate the Food, Drug and Cosmetic Act. It is unclear if federal authorities would enforce the law against the drug if the court revokes its approval, but threatening access to mifepristone – especially in states that are hostile to abortion care – could jeopardise abortion access for millions of Americans.

The drug was first approved by the FDA 2000. Subsequent changes have allowed the drug to be used up to 10 weeks of pregnancy, a period when a vast majority of abortions in the US are performed.

A federal appeals court has blocked those changes, along with newer guidelines that allow the drug to be prescribed via telehealth appointments. The appeals court ruling also would mean the drug could only be used up to seven weeks, when most people are learning they are pregnant.

A previous ruling from a federal judge in Texas would not only roll back those changes but revoke the FDA’s approval entirely.

The Supreme Court has blocked those decisions, at least for now, while the legal challenges play out.

We should know by the end of the day what will happen next.

Alex Woodward21 April 2023 18:30
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Matthew Kacsmaryk, the Trump-appointed judge who could threaten access to mifepristone

A decision from a single judge with a history of anti-abortion activism could determine reproductive healthcare decisions for millions of Americans, not just in states where abortion already faces severe restrictions but in states where access to care is legally protected.

Who is Trump-appointed judge Matthew Kacsmaryk trying to ban abortion drug?

The controversial federal judge in Texas has presided over several cases with far-reaching national implications

Alex Woodward21 April 2023 19:10
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What has the White House said about the case?

When the Supreme Court temporarily paused a lower court decision on mifepristone, White House press secretary Karine Jean-Pierre issued a statement stressing that “mifepristone remains available and approved for safe and effective use.”

President Joe Biden’s administration will “continue to stand by FDA’s evidence-based approval of mifepristone, and we will continue to support the FDA’s independent, expert authority to review, approve, and regulate a wide range of prescription drugs,” she added. “The stakes of this fight could not be higher in the face of ongoing attacks on women’s health, and we will continue to fight to restore the protections of Roe v Wade.”

In an earlier statement condemning Judge Kacsmaryk’s initial ruling, the president said that 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.” “The prescription medication in question in this case is used for medication abortion, and medication abortion accounts for over half the abortions in America,” he added. “The lawsuit, and this ruling, is another unprecedented step in taking away basic freedoms from women and putting their health at risk. ... It is the next big step toward the national ban on abortion that Republican elected officials have vowed to make law in America.” He also renewed his call for members of Congress to codify abortion rights protections affirmed by Roe v Wade into law.

Vice President Kamala Harris also criticised the appeals court ruling that backed parts of Judge Kacsmaryk’s decision.

“The Fifth Circuit’s decision – just like the district court’s – second-guesses the agency’s medical experts,” she said in a statement. “If this decision stands, no medication – from chemotherapy drugs, to asthma medicine, to blood pressure pills, to insulin – would be safe from attacks.” She added: “There is a reproductive health care crisis in America. Our Administration will continue fighting to protect women’s health and the right to make decisions about one’s own body.”

(REUTERS)
Alex Woodward21 April 2023 19:45
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The judge who wants to block mifepristone removed his name from an anti-abortion article before his Senate confirmation

The federal judge who wants to revoke the FDA’s approval of mifepristone withdrew his name from a legal journal article about abortion that was drafted in the middle of his Senate confirmation process – something he failed to disclose to lawmakers who interviewed him.

Judge in mifepristone case failed to disclose writing anti-abortion article

US District Judge Matthew Kacsmaryk reportedly failed to disclose to lawmakers that he wrote an article defending religious objections to abortion access and gender-affirming care

Alex Woodward21 April 2023 20:37

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