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 withdrawing the Food and Drug Administration’s (FDA) approval of mifepristone, marketed as Mifeprex, which would restrict its use nationwide. discontinued.
Mifepristone is half of the two-drug cocktail – along with misoprostol – that allows a woman to terminate her pregnancy in the comfort of their own home.
The pills gained prominence in the wake of the U.S. Supreme Court’s decision to overturn Roe v Wade last summer. For women in the 24 states where abortion is illegal or severely restricted.
A majority of U.S. abortions are performed with this drug. The drugs have recently become available at pharmacies across the US through a new order from the Biden administration — even in states where abortion is banned.
Mifepristone, unlike its misoprostol counterpart, is only approved for abortion care and for some miscarriages. It was approved in 2000. About half of abortions are performed using the two-pill system
He is expected to rule in favor of the anti-abortion group Alliance Defending Freedom that brought the case.
The ruling would have far-reaching implications for American women, even in states where abortion remains legal.
An attempt to withdraw FDA approval would almost certainly be immediately challenged by abortion rights activists, although the Fifth Circuit Court of Appeals that would hear the case is also deeply politically conservative.
Medication-induced abortions make up the bulk of abortions performed today due to the 2021 Supreme Court decision in Dobbs v. Jackson, which revoked a federal guarantee for the procedure.
The future of access to abortion in the US hinges on the thinking of Judge Matthew Kacsmaryk of the United States District Court for the Northern District of Texas, who scheduled the hearing for Wednesday after trying to evade the press.
The case in question is the Alliance for Hippocratic Medicine versus the US FDA, submitted for the first time at the end of last year to challenge the FDA’s approval of Mifeprex in 2000, which was the result of rigorous rounds of safety and efficacy testing and 12 years of proven safe use abroad in France.
The conservative anti-abortion group Alliance Defending Freedom, which sued the plaintiffs, is expected to do well in Judge Kacsmaryk’s court.
Kacsmaryk was appointed to the bench by former President Donald Trump in 2019 and has a judicial record that aligns with conservative Christian ideology.
The ADF, on the part of the Alliance for Hippocratic Medicine and Anti-Abortion Care Providers, argues that: “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 abortion drugs has spanned three decades, correlated with four US presidential elections, and included six separate agency actions. Plaintiffs are challenging these six FDA actions and are asking the court to declare them illegal, set them aside and strike them down.”
They allege that the FDA has abused its authority by approving mifepristone, marketed as Mifeprex, on the accelerated approval path reserved for new drugs that would benefit patients with serious or life-threatening illnesses beyond what is currently on the market. is available.
They said the approval process used by the FDA required pregnancy to be considered a “disease,” for which the drug would provide “meaningful therapeutic benefit.”
“But pregnancy is not a disease,” the claimants state in their complaint.
Mifepristone, when used in combination with misoprostol, the anti-ulcer drug, has been shown to be safe and effective in terminating a pregnancy within approximately 10 weeks (clinical guidelines allow use up to 11 weeks) after a woman’s last menstrual period.
The conservatives’ argument that mifepristone is not safe goes against the guidelines of obstetricians and gynecologists, as well as the wider scientific community.
A 2012 meta-analysis of 87 clinical trials published in journal Birth control confirmed that medication abortion is generally safe, with serious complications such as severe vaginal bleeding, pelvic pain or infection requiring hospitalization occurring in less than 0.3 percent of patients.
In fact, studies show that mifepristone is safer and safer sends fewer people to the emergency department than Tylenol and Viagra.
It took the FDA four years from the drug’s first submission to approve Mifeprex. The trial was unhurried and included years of clinical data pointing to its safety and efficacy.
The FDA responded to that said of a ruling in favor of the anti-abortion plaintiffs: “It would upend the status quo and dependency interests of patients and physicians dependent on mifepristone, as well as companies involved in the distribution of mifepristone. The balance of fairness and the public interest therefore also argue strongly for rejection of the claimant’s request.’
The agency added that the court would set a dangerous precedent by overturning the 2000 approval.
The agency said: “More broadly, if long-standing FDA drug approvals were so easily enforced, even decades after they are issued, pharmaceutical companies would not be able to confidently rely on FDA approval decisions to develop pharmaceutical drug infrastructure. on which Americans depend for a variety of health problems.”
A preliminary injunction would override Congress’s decision to give the FDA the responsibility to ensure the safety and efficacy of drugs. In fulfilling this role, the FDA applies its technical expertise to make complex scientific determinations about the safety and efficacy of drugs, and these determinations are entitled to substantial respect.’
Even facing a possible loss of approval, women will find other ways to access the drugs.
Women are turning to the FDA-approved abortion drugs manufactured and shipped from abroad through the Aid Access organization, even though the legal situation is murky and potentially risky. Aid Access claims it will continue to send abortion-inducing drugs to women in all US states, including those that have banned the procedure.