A Trump-appointed judge in Texas is expected to ban abortion pills as early as Wednesday.
Judge Matthew Kacsmaryk of the US District Court for the Northern District of Texas will consider reversing the Food and Drug Administration’s (FDA) approval of mifepristone, marketed as Mifeprex, which would halt its use nationwide.
Mifepristone is one-half of the two-drug cocktail — along with misoprostol — that allows a woman to terminate their pregnancy in the comfort of their own home.
The pills rose to prominence in the wake of 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 severely restricted.
A majority of US abortions are carried out with this medication. The drugs recently became available at pharmacies across the US through a new Biden Administration order — even in states where abortion is banned.
Mifepristone, unlike its counterpart misoprostol, is only approved for abortion healthcare, as well as, for some miscarriages. It was approved in 2000. Roughly one-half of abortions are completed 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.
A move to revoke FDA approval would almost certainly be appealed immediately by abortion rights activists, though the appeals court at the fifth circuit that would weigh the case is also very politically conservative.
Medication-induced abortions make up the majority share of abortions carried out today due to the Supreme Court’s 2021 decision in Dobbs v. Jackson that revoked a federal guarantee to the procedure.
The future of abortion access 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 vs the US FDA, first filed late last year to challenge the FDA’s approval of Mifeprex in 2000, which was a result of stringent rounds of safety and efficacy tests and 12 years of proven safe use abroad in France.
The conservative anti-abortion group Alliance Defending Freedom, which filed the suit for the plaintiffs, is expected to fare well in Judge Kacsmaryk’s court.
Kacsmaryk was appointed to the bench by former President Donald Trump in 2019 and has a judicial track record that aligns with conservative Christian ideology.
The ADF, on the part of the Alliance for Hippocratic Medicine and anti-abortion healthcare providers, argue that: ‘The FDA failed America’s 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 U.S. presidential elections, and encompassed six discrete agency actions. Plaintiffs challenge these six FDA actions and ask that the Court hold them unlawful, set them aside, and vacate them.’
They allege that the FDA abused its authority by approving mifepristone, marketed as Mifeprex, on the accelerated approval pathway reserved for new drugs that would benefit patients with serious or life-threatening illnesses more than what is currently available on the market.
They said that the approval pathway used by the FDA required it to consider pregnancy an ‘illness,’ for which the drug would provide ‘meaningful therapeutic benefit.’
‘But pregnancy is not an illness,’ the plaintiffs state in their complaint.
Mifepristone, when used in combination with the stomach ulcer drug misoprostol has been shown to be safe and effective at terminating a pregnancy within about 10 weeks (clinical guidance allows use up to 11 weeks) of the woman’s last period.
The conservatives’ argument that mifepristone is not safe flies in the face of guidance from obstetricians and gynecologists as well as the wider scientific community.
A 2012 meta-analysis of 87 clinical trials published in journal Contraception affirmed 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 mifepristone is safer and sends fewer people to the emergency department than Tylenol and Viagra.
It took the FDA four years from initial drug submission to approve Mifeprex. The process was not rushed and included years of clinical data pointing to its safety and efficacy.
The FDA, in response, said of a ruling in favor of the anti-abortion plaintiffs: ‘It would upend the status quo and the reliance interests of patients and doctors who depend on mifepristone, as well as businesses involved with mifepristone distribution. The balance of the equities and the public interest thus also strongly favor denial of Plaintiffs’ motion.’
The agency added that in overturning the 2000 approval, the court would set a dangerous precedent.
The agency said: ‘More generally, if longstanding FDA drug approvals were so easily enjoined, even decades after being issued, pharmaceutical companies would be unable to confidently rely on FDA approval decisions to develop the pharmaceutical-drug infrastructure that Americans depend on to treat a variety of health conditions.’
‘A preliminary injunction would interfere with Congress’s decision to entrust FDA with responsibility to ensure the safety and efficacy of drugs. In discharging this role, FDA applies its technical expertise to make complex scientific determinations about drugs’ safety and efficacy, and these determinations are entitled to substantial deference.’
Even in the face of a possible loss of approval, women will find other ways to access the drugs.
Women are turning to the FDA-approved abortion drugs produced and shipped from overseas through the organization Aid Access, though the legal situation is murky and potentially risky. Aid Access maintains that it will continue to mail out abortion-inducing medication to women in all U.S. states, including those that have banned the procedure.