An abortion pill approved in the US more than 20 years ago could now be pulled.
US district judge Matthew J Kacsmaryk has signed an injunction directing the Food and Drug Administration (FDA) to halt the approval of mifepristone while a lawsuit by a conservative Christian group challenging its safety continues.
The outcome could halt half the legal abortions carried out across the country, including in states led by Democrats where abortion rights are protected.
This comes nearly a year after the Supreme Court overturned Roe v Wade – which had previously given women rights to terminate a pregnancy.
What is mifepristone?
The drug was first approved by the FDA in September 2000 for medical termination up to seven weeks into pregnancy, extended to 10 weeks in 2016.
The FDA has said mifepristone is safe to use as “directed and consistent with the Mifepristone Risk Evaluation and Mitigation Strategy (REMS)” programme, and that the pill was approved based on a comprehensive review of scientific evidence.
It is one of two drugs used for medication abortion in the US, along with misoprostol, which is also used to treat other medical conditions. The two are often combined.
Clinics and doctors have said that if mifepristone were to be pulled from the market, they would switch to using misoprostol only.
The single drug approach has a lower rate of effectiveness in ending pregnancies, but is used across the country where mifepristone may be unavailable or illegal.
Who is the judge involved?
Mr Kacsmaryk, 45, was nominated by Donald Trump in 2017 and his confirmation took place in 2019.
Known for his conservative views, senate Democrats and a number of LGBTQ advocacy groups opposed his nomination due to his comments and views on LGBTQ rights and women’s rights to contraception.
He previously worked for First Liberty Institute, a conservative legal group that has backed many religious-based challenges through federal courts, including the Supreme Court.
In December 2022, he prevented clinics from providing contraception to minors without parental consent.
Earlier this year, in comments to The Washington Post, his sister Jennifer Griffith spoke about her brother and his anti-abortion views.
“He’s very passionate about the fact that you can’t preach pro-life and do nothing,” she was quoted as saying.
How can one judge in Texas change national policy?
The injunction the court has ordered is nationwide – effectively the court says if a federal policy or law is in question in Texas it is in question across the US.
Nationwide injunctions are rare but have precedents. Donald Trump’s travel ban on people from mainly Muslim countries in early 2017 was held up for months by several judges using similar orders.
The whole area is the subject to legal debate over the power held by judges. Parties in cases have also been accused of ‘forum shopping’ or seeking out a judge or local administration that will be sympathetic to their case.
What was the challenge?
On Friday, Mr Kacsmaryk signed an injunction directing the FDA to halt mifepristone’s approval, giving the government seven days to appeal the ruling.
Since the Texas lawsuit was filed by Alliance Defending Freedom, representing four anti-abortion groups and four anti-abortion doctors, in November, legal experts have warned of questionable arguments and inaccuracies in the Christian group’s filing – which alleges the FDA’s approval of the drug was flawed and not adequately reviewed for its safety risks.
Mr Kacsmaryk agreed with the complainants on all their major points, including that the FDA did not properly review mifepristone’s safety.
“The court does not second-guess FDA’s decision-making lightly,” the judge wrote in a 67-page order.
He added: “But here, FDA acquiesced on its legitimate safety concerns – in violation of its statutory duty – based on plainly unsound reasoning and studies that did not support its conclusions.”
‘Benefits outweigh any risks’
In the lawsuit, the Alliance for Hippocratic Medicine, which heads the anti-abortion groups, alleges that medication abortion has “potentially serious and life-threatening effects”.
However, studies have shown this is not the case; doctors have found 0.4% risk of major complications associated to the pill and a 99.6% chance of a successful termination.
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The FDA has argued that the “benefits of mifepristone outweigh any risks”.
If the order is approved, it would also dismantle a number of recent FDA actions intended to ease access to the drug.
‘Taking away basic freedoms from women’
In response to the order, President Joe Biden said: “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.”
Mr Biden said the lawsuit and the ruling is “another unprecedented step in taking away basic freedoms from women and putting their health at risk.
“This does not just affect women in Texas – if it stands, it would prevent women in every state from accessing the medication, regardless of whether abortion is legal in a state.”
Mr Biden said the ruling could be the “next big step” towards a national ban on abortion that many Republican elected officials have vowed to make a law in the US.
President Biden also said his administration will “fight” the ruling and said an appeal has been filed.
Roe v Wade
The pills have become increasingly significant in the fight over abortion access since Roe v Wade was overturned in June 2022.
The ruling trigged a wave of changes across the country, with clinics closing and abortion bans closing in.
Many states have since passed near-total bans on abortion with very limited exceptions.
As of January 2023, there were 12 states enforcing a near-total ban on abortion – with the ban being challenged in five states.
The 12 states are:
• South Dakota
• West Virginia