A Trump-appointed judge in Texas is expected to ban abortion pills as early as Wednesday.
Judge Matthew Kacsmaryk of the U.S. District Court for the Northern District of Texas will consider rescinding the Food and Drug Administration (FDA) approval of mifepristone, marketed as Mifeprex, which would end its use in all the country.
Mifepristone is half of the two-drug cocktail – along with misoprostol – that allows a woman to terminate her pregnancy in the comfort of her own home.
The pills rose to prominence following the US Supreme Court’s decision to overturn Roe v Wade last summer. For women in the 24 states where abortion is either illegal or strictly regulated, this may be their only recourse.
The majority of abortions in the United States are performed with this drug. The drugs recently became available in pharmacies across the United States thanks to a new prescription from the Biden administration, even in states where abortion is banned.
Mifepristone, unlike its counterpart misoprostol, is only approved for abortion care. It was approved in 2000. About half of abortions are performed using the two-pill system
The case in question is the Hippocratic Medicine Alliance v. the US FDA, first filed late last year challenging the FDA’s 2000 approval of Mifeprex.
It was filed by the anti-abortion group Alliance Defending Freedom (ADF).
The group argues that the drug’s approval is overridden by the Comstock Act of 1873 – which prohibits the sale of immoral or indecent products by mail.
They argue that the law should make it illegal to mail the drug, and that FDA approval to do so should be removed.
Judge Kacsmaryk, who was nominated by President Trump and then confirmed by a 52-49 Senate vote in 2019, is known as an anti-abortion advocate and is expected to rule in favor of the group.
The decision would have profound implications for American women, even in states where abortion remains legal.
A decision to revoke FDA approval would almost certainly be appealed immediately by abortion rights activists.
But, the Fifth Circuit Court of Appeals that would weigh the case is also very politically conservative.
Judge Matthew Kacsmaryk (pictured) is a Texas federal judge who will rule on the mifepristone case. He was nominated by former President Donald Trump and sat in his role in 2019
Medical abortions make up the majority of abortions performed today due to the 2021 Supreme Court ruling in the Dobbs v. Jackson case that revoked federal protections for the procedure.
The drug has received FDA approval for more than two decades, following rigorous rounds of safety and efficacy testing and 12 years of safe use in France.
The ADF, on behalf of the Hippocratic Medicine Alliance and anti-abortion health care providers, says, “The FDA failed American women and girls when it chose politics over science and approved chemical abortion drugs for use in the United States.
“To date, the FDA’s review, approval, and deregulation of chemical abortifacient drugs spans three decades, correlates to four U.S. presidential elections, and encompasses six separate agency actions. Plaintiffs challenge those six actions of the FDA and ask the Court to declare them illegal, reverse them and set them aside.
They allege the FDA abused its authority by approving mifepristone on the fast track.
This is reserved for new drugs that would benefit patients with serious or life-threatening conditions more than what is currently available on the market.
They said the approval pathway used by the FDA required it to consider pregnancy a “disease”, for which the drug would provide “significant therapeutic benefit”.
“But pregnancy is not a disease,” the plaintiffs state in their complaint.
Mifepristone, when used in combination with misoprostol, a medicine for stomach ulcers, has been shown to be safe and effective in terminating a pregnancy within about 10 weeks of a woman’s last menstrual period.
If the Texas judge were to rule in favor of the preservatives, the FDA would have to act. According to Rachel Rebouché, a reproductive rights expert at Temple University, the FDA could work to reapprove the drug, but it could take years.
Professor Rebouché told DailyMail.com: “The biggest problem is that it’s always a federal court that tells a federal agency, that is the drug safety and efficacy expert, that 23 years ago he did not properly approve a drug.
“We haven’t really seen that when a court steps in to try to reverse-engineer a drug approval process decades after the drug hit the market. We certainly haven’t seen it for a drug as safe as mifepristone.
The Conservatives’ argument that mifepristone is unsafe goes against the advice of obstetricians and gynecologists as well as the wider scientific community.
A 2012 meta-analysis of 87 clinical trials published in the journal Contraception asserted that medical abortion is generally safe.
In the study, serious complications such as severe vaginal bleeding, pelvic pain or infection requiring hospitalization occurred in less than 0.3% of patients.
Studies show that mifepristone is safer and sends fewer people to the emergency room than Tylenol and Viagra.
The FDA, in response, said of a ruling in favor of anti-abortion plaintiffs: ‘It would upset the status quo and the trusted interests of patients and doctors who rely on mifepristone, as well as companies involved in distribution of mifepristone. The balance of actions and the public interest therefore also strongly favor the dismissal of the plaintiffs’ motion.
The agency added that by reversing the 2000 approval, the court would set a dangerous precedent.
The agency said: “More generally, if long-standing FDA drug approvals were so easily enforced, even decades after they were issued, pharmaceutical companies could not confidently rely on FDA decisions. FDA approval to develop the pharmaceutical infrastructure that Americans depend on to treat a variety of health conditions.
“A preliminary injunction would interfere with Congress’s decision to give the FDA responsibility for ensuring drug safety and efficacy. In performing this role, the FDA applies its technical expertise to make complex scientific decisions about drug safety and effectiveness, and those decisions are entitled to substantial deference.