Last Friday, a federal judge in Texas suspended the approval of a widely used abortion medication in the United States.
The drug, called mifepristone, is one of two drugs frequently used for medication abortions that has repeatedly been proven to be safe and effective. Currently, it accounts for more than half of all US abortions.
Trump-appointed US District Judge Matthew Kacsmaryk issued a preliminary injunction which directs the Food and Drug Administration (FDA) to put a hold on the approval of mifepristone while a lawsuit challenging the safety and approval of the drug is underway.
Kacsmaryk said the FDA – the agency that approves the safety of food products and drugs in the US, exceeded its authority by ignoring mifepristone’s risks and relying on “plainly unsound reasoning” when approving it more than 20 years ago.
Mifepristone is part of a two-drug regimen — Mifepristone stops a pregnancy, while a second drug, misoprostol, empties the uterus. It is used as a medication abortion in the first ten weeks of pregnancy.
Mifepristone’s safety and effectiveness is supported by mainstream medical bodies including the World Health Organisation (WHO) and the American College of Obstetrics and Gynaecologists (ACOG).
The ruling by Judge Kacsmaryk is said to be the most significant anti-abortion move since Roe V Wade was overturned less than a year ago.
Advocates and progressive states have been bracing for significant fallout from the decision and further risks to women, with many states reacting swiftly, including by stockpiling the drug to make sure it’s available.
Below, we share more on the reaction to the ruling and what’s being done to counter it.
Initial Reaction to the Ruling
President Joe Biden responded to the decision on Friday, saying his administration would fight Kacsmaryk’s ruling.
“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,” he said in a statement.
“Let’s be clear – the only way to stop those who are committed to taking away women’s rights and freedoms in every state is to elect a Congress who will pass a law restoring Roe versus Wade.”
Vice-president Kamala Harris said the decision “threatens the rights of women nationwide to make decisions about their healthcare and the ability to access medication prescribed to them by their doctors”.
The attorney general, Merrick Garland described the decision as one that “overturns the FDA’s expert judgment, rendered over two decades ago, that mifepristone is safe and effective.”
“The justice department strongly disagrees with the decision of the district court for the northern district of Texas in Alliance for Hippocratic Medicine v FDA and will be appealing the court’s decision and seeking a stay pending appeal,” he said.
Who is pushing the case against mifepristone
In November 2022, Arizona-based Christian conservative legal advocacy group, Alliance Defending Freedom (ADF) bought a lawsuit against the FDA arguing that the government body exceeded its regulatory authority when it approved mifepristone in September 2000.
The plaintiffs wanted the approvals of chemical abortion drugs withdrawn and for them to be completely removed from the list of approved drugs.
They presented a series of points that they said put pregnant women and girls at risk, including the FDA’s decision to extend the gestational age up to which mifepristone may be prescribed, and its decision to remove the mandatory in-person dispensing over the drugs during the pandemic.
They said the FDA “failed to acknowledge and address the federal laws that prohibit the distribution of chemical abortion drugs by postal mail”, inciting a 19th-century law that made sending “obscene, lewd or lascivicious” items through the mail illegal.
“Simply put, FDA stonewalled judicial review – until now,” Kacsmaryk wrote in his ruling.
Judge Kacsmaryk, a devout Christian, based in Amarillo, Texas and has worked for the First Liberty Institute, a conservative Christian organisation whose work focuses on litigating against LGBTQ+ and abortion rights.
Kacsmaryk has written critically about Roe v Wade, writing in 2015 for Public Discourse, a conservative legal journal, that the seven justices had “found an unwritten ‘fundamental right’ to abortion hiding in the due process clause of the Fourteenth Amendment and the shadowy ‘penumbras’ of the Bill of Rights, a celestial phenomenon invisible to the non-lawyer eye.”
US Government’s appeal
On Monday this week, the US government appealed Kacsmaryk’s decision, saying the ruling endangered women’s health by blocking access to mifepristone.
The Department of Justice called the decision “especially unwarranted” since it undermines the FDA’s scientific judgment and harms women for whom the drug is medically required.
The appeal called Kacsmaryk’s decision one that “upended decades of reliance by blocking FDA’s approval of mifepristone and depriving patients of access to this safe and effective treatment, based on the court’s own misguided assessment of the drug’s safety.”
The appeal also criticised the anti-abortion groups that sought to overturn the FDA’s approval, saying they had no right to sue in the first place, since “the plaintiffs present no evidence that they will be injured at all, much less irreparably harmed, by maintaining the status quo they left unchallenged for years.”
White House spokesperson, Karine Jean-Pierre said Biden’s administration “stands by the FDA and is prepared for this legal fight, and we will continue our work to protect reproductive rights.”
The conflicting case
Less than half an hour after Kacsmaryk made his decision on Friday, a federal judge in Washington state ordered the FDA not to take any action that would affect mifepristone’s availability, directing the FDA to keep the drug available in 17 states, thereby contradicting Kacsmaryk’s ruling.
The Department of Justice has asked U.S. District Judge Thomas O. Rice to clarify what needs to happen as this legal standoff unfolds. Lawyers from the Biden administration have asked for a decision to be made by 13 April.
Rice, an Obama-appointed judge, ordered the FDA to preserve “the status quo” in his 31-page decision and said “Based on the public health and administrative considerations at issue in this case… the public interest favors a preliminary injunction.”
States stock up
The Democratic governor of Washington state, Jay Inslee announced he has purchased a three-year supply of the leading abortion medication.
Inslee said he ordered the department of corrections to obtain 30,000 doses of the generic version of mifepristone. The shipment arrived late last month.
“This Texas lawsuit is a clear and present danger to patients and providers all across the country,” Inslee said in a statement. “Washington will not sit by idly and risk the devastating consequences of inaction.”
California Governor Gavin Newsom said his state has secured up to two million pills of misoprostol.
Massachusetts Governor Maura Healey announced her state had ordered roughly 15,000 doses of mifepristone.
“A judge has made a politically motivated decision to override doctors, patients and medical experts and block access to critical medications,” Healey said .
“Today, we collectively are saying loud and clear: not on our watch.”
According to the non-profit Guttmacher Institute, a total of twelve states in the US currently ban abortion, while 14 others ban it after six to 22 weeks of pregnancy.
Currently, mifepristone remains available to the public in the US. Earlier this week, hundreds of pharmaceutical executives called for the reversal of Kacsmaryk’s ruling, calling it a “decision to disregard science”.