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
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Your support makes all the difference.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.
How did mifepristone end up in front of the Supreme Court?
Here is a brief timeline of the latest case, which was filed a few months after the US Supreme Court struck down the constitutional right to abortion care last summer:
- In November, the right-wing legal group Alliance Defending Freedom filed a lawsuit in US District Court in Amarillo, Texas on behalf of a group of anti-abortion activists incorporated as the Alliance for Hippocratic Medicine, which was organised that same month with an address in Amarillo.
- The Alliance Defending Freedom also led the challenge at the Supreme Court that ultimately struck down Roe v Wade.
- US District Judge Matthew Kacsmaryk – a former anti-abortion lawyer who was appointed to the federal judiciary by Donald Trump – held a hearing in the case on 15 March in Amarillo.
- Earlier this month, Judge Kacsmaryk issued a ruling to suspend the FDA’s approval of mifepristone. His order was set to take effect a week later, pending a decision from on appeal. But in a separate ruling in Washington state, a federal judge ruled that the FDA cannot change the status quo when it comes to mifepristone’s approval, setting up potentially duelling decisions over the drug.
- Abortion rights advocates, providers, major medical groups and legal analysts condemned the ruling, and the US Department of Justice and Danco Laboratories, which manufactures mifepristone, filed an appeal.
- That appeal landed at the US Court of Appeals for the Fifth Circuit, which has jurisdiction over the Amarillo court.
- A three-judge panel on the Fifth Circuit blocked a part of the judge’s ruling, but struck against mail-in prescriptions and rules that expanded the drug’s approval for use up to 10 weeks of pregnancy.
- The Supreme Court has blocked the Texas ruling while it considers the case.
Just in: Judge at centre of mifepristone case concealed the sources of millions of dollars in stock holdings
The federal judge whose nationwide ruling could block the government’s approval of a widely used abortion drug appears to have redacted critical information from his financial disclosure forms, hiding millions of dollars in his personal fortune.
In 2020 and 2021 annual disclosures reviewed by CNN, US District Judge Matthew Kacsmaryk wrote that he held between $5m and $25m in “common stock” of a company.
But the name of the company is redacted. Federal law only allows redactions of information that could “endanger” a judge or their family member.
The redacted holding accounted for at least 85 per cent of Mr Kacsmaryk’s total reported wealth in 2021, CNN found.
Maya Oppenheim, The Independent’s women’s correspondent, underscores what is at stake with the Supreme Court’s imminent decision in the mifepristone case and the potential outcomes in federal courts:
Having a medical abortion involves taking two tablets, with mifepristone being the first of these. Millions around the world have taken the drug to terminate a pregnancy over recent decades - myself included. I took mifepristone last year and wrote about my nightmare struggle to get an abortion here in the UK. Mifepristone is one of the most scrupulously studied drugs in the world. The UK’s largest study into abortions previously found that at-home early medical abortions pose no greater risk and allow women to have the procedure much earlier on in their pregnancy. Medical abortions constitute more than half of all abortions in America. Nevertheless, Axios has found almost half of US states have either totally banned or restricted access to abortion pills.
Moreover, later on in the legal process, if Kacsmaryk’s ruling comes into force, abortion providers will only be able to conduct surgical abortions or medical abortions which only use the second abortion drug misoprostol. Despite the fact abortions carried out by such means still work, they inflict more pain and take more time. Moreover, while surgical abortions are wholly safe, they are more dangerous than medical abortions. Ultimately, they are a totally different entity to medical abortions as they involve going into theatre for surgery – thus they are far more expensive to conduct, as well taking far longer, and being far more painful.
Read more below:
The Handmaid’s Tale could become reality in the US at midnight tonight | Voices
Millions around the world have taken mifepristone to terminate a pregnancy – myself included
Why this isn’t a ‘typical’ Supreme Court decision
The US Supreme Court did not take on the case of Alliance for Hippocratic Medicine v the FDA in the same way that other major cases before the court have appeared. There were no oral arguments in front of the court, where lawyers from both parties would make their case in front of the nine-member panel, which would then spend weeks or months considering the case and writing opinions and dissents.
Instead, the case before the court is a decision on an appeal from a lower court.
A federal court judge in Texas issued a ruling that revokes the FDA’s approval of mifepristone. That decision was appealed, and a federal appeals court kept some parts of the ruling and stripped away others. The Biden administration and Justice Department filed an emergency appeal to halt that decision with the Supreme Court.
So far, the Supreme Court has paused the lower court’s ruling while the court determines what to do next. That pause was set to expire at midnight tonight.
So what happens now? The Supreme Court’s decision on whether to keep that pause in place is expected some time before the court’s current pause expires.
Can the FDA just ignore the ruling?
That’s what several members of Congress have argued, though President Joe Biden’s administration and abortion rights advocates have stressed that the case must play out in court and affirm the FDA’s ability to make such decisions.
Democratic senator Ron Wyden, the chair of the Senate Finance Committee, which oversees the FDA, has repeatedly argued that the administration ignore a ruling that undermines the FDA’s regulatory powers.
US Rep Alexandria Ocasio-Cortez has argued that an increasingly partisan-driven federal judiciary weaponised by right-wing activist groups has undermined its legitimacy in making such decisions.
Republican US Rep Nancy Mace also has suggested that a ruling that revokes the FDA’s approval of the drug should be ignored or tossed out.
What happens if mifepristone is not available?
Abortion providers and civil rights groups have warned of grave consequences to the loss of widely used abortion drugs from the market.
Providers could turn to a misoprostol-only medication abortion regimen, though that would be considered an “off-label” pharmaceutical use for the drug in the US. Misoprostol is currently approved by the FDA for the prevention and treatment of gastric ulcers but also is administered for other obstetric or gynecologic care.
Several Democratic-led states are stocking up on mifepristone and proposing legal protections for pharmacists and providers who dispense the drug.
A ruling that undermines the FDA’s drug approval process could also open the door for other activist-driven legal battles over other drugs, potentially inviting other destabilising lawsuits to Covid-19 vaccines, contraception, HIV medication, gender-affirming care, and other life-saving drugs.
The Biden administration will “continue to fight” for abortion rights regardless of the court’s decision, White House press secretary Karine Jean-Pierre told reporters on 19 April.
Breaking: Supreme Court preserves abortion drug approval as case continues
The US Supreme Court has preserved access to a widely used abortion drug while legal challenges against mifepristone’s government approval continue.
The decision from the nation’s high court on 21 April preserves the US Food and Drug Administration’s approval of the drug, which is used in more than half of all abortions in the US, after a federal judge in Texas struck it down in a ruling that would have profound and potentially dangerous consequences for millions of Americans.
Mifepristone will remain legal and accessible, with the FDA’s approval intact.
Stay tuned with The Independent
Joe Biden issues statement after Supreme Court decision
President Joe Biden said the Supreme Court’s decision blocks a ruling that “would have undermined FDA’s medical judgment and put women’s health at risk.”
“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,” he added.
“I continue to stand by FDA’s evidence-based approval of mifepristone, and my administration will continue to defend FDA’s independent, expert authority to review, approve, and regulate a wide range of prescription drugs,” the president continued.
“The stakes could not be higher for women across America,” he said. “I will continue to fight politically-driven attacks on women’s health. But let’s be clear – the American people must continue to use their vote as their voice, and elect a Congress who will pass a law restoring the protections of Roe v Wade.”
Major US abortion rights groups welcome Supreme Court decision but warn ‘we’re not out of the woods yet'
Mifepristone will remain legal and accessible, with the FDA’s approval intact. The case now returns to the Fifth Circuit Court of Appeals in Louisiana, where both parties will have a chance to file briefs. The case will be argued before a three-judge panel on 17 May.
“The Supreme Court’s decision is a huge relief, but we’re not out of the woods yet,” said Nancy Northup, president and CEO of the Center for Reproductive Rights.
“The lower court ruling out of Texas has zero basis in fact or law – and yet it has sowed chaos, confusion and panic for patients and providers across the country, including those in states with strong protections for abortion rights,” she added. “That crisis was not resolved today.”
Jennifer Dalven, director of the ACLU Reproductive Freedom Project, also welcomed the Supreme Court’s decision, adding that “it is 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.”
“Patients shouldn’t have to monitor Twitter to see whether they can get the care they need,” she added.
Anti-abortion legal group leading mifepristone lawsuit vows to continue challenge
The senior counsel for the Alliance Defending Freedom, the legal group leading the challenge to mifepristone on behalf of a group incorporated as the Alliance for Hippocratic Medicine, issued a statement acknowledging the Supreme Court’s decision.
“As is common practice, the Supreme Court has decided to maintain the status quo that existed prior to our lawsuit while our challenge to the FDA’s illegal approval of chemical abortion drugs and its removal of critical safeguards for those drugs moves forward,” Erik Baptist said.
The right-wing legal group also led the challenge at the Supreme Court that ultimately struck down Roe v Wade last year in the high court’s conservative supermajority decision in Dobbs v Jackson Women’s Health Organization, which revoked a constitutional right to abortion care.
“The FDA must answer for the damage it has caused to the health of countless women and girls and the rule of law by failing to study how dangerous the chemical abortion drug regimen is and unlawfully removing every meaningful safeguard, even allowing for mail-order abortions,” Mr Baptist addded. “We look forward to a final outcome in this case that will hold the FDA accountable.”
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