A Trump-appointed judge in Texas is expected to ban abortion pills starting Wednesday.
Judge Matthew Kacsmaryk of the US District Court for the Northern District of Texas will consider revoking the Food and Drug Administration (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 her pregnancy in the comfort of her 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 illegal or severely restricted.
Most abortions in the United States are performed with this medication. The drugs recently became available in US pharmacies through a new order from the Biden Administration, even in states where abortion is prohibited.
Mifepristone, unlike its counterpart misoprostol, is only approved for medical abortion care, as well as some miscarriages. It was approved in 2000. Approximately half of abortions are completed using the two-pill system.
The case in question is the Alliance for Hippocratic Medicine vs. the US FDA, first introduced late last year to challenge the FDA’s approval of Mifeprex in 2000.
It was introduced by the anti-abortion group Alliance Defending Freedom (ADF).
The group argues that the drug’s approval is nullified by the Comstock Act of 1873, which prohibits the sale of immoral or indecent products through the mail.
They argue that the law should make it illegal to send the drug through the mail, and the FDA’s approval to do so should be withdrawn.
Judge Kacsmaryk, who was appointed by President Trump and later confirmed by a 2019 52-49 Senate vote, is known as an anti-abortion advocate and is expected to rule in favor of the group.
The ruling would have far-reaching implications for American women, even in states where abortion remains legal.
A move to revoke the FDA’s approval would surely be immediately appealed by abortion rights activists.
But, the fifth circuit court of appeals that would hear the case is also very politically conservative.
Judge Matthew Kacsmaryk (pictured) is a federal judge in Texas who will rule on the mifepristone case. He was appointed by former President Donald Trump and took office in 2019.
Medically induced abortions make up the majority of abortions performed today due to the 2021 Supreme Court decision in Dobbs v Jackson that struck down federal protections for the procedure.
The drug has had FDA approval for more than two decades, which came after stringent rounds of safety and efficacy testing and 12 years of safe use in France.
The ADF, on behalf of the Alliance for Hippocratic Medicine and anti-abortion health care providers, argue that: ‘The FDA failed American women and girls when it chose politics over science and approved chemical abortion drugs for their use in the United States.
‘To date, the FDA’s review, approval, and deregulation of chemical abortion drugs has spanned three decades, correlated to four US presidential elections, and spanned six discrete agency actions. The plaintiffs are challenging these six FDA actions and request that the Court declare them unlawful, quash and quash them.’
They allege that the FDA abused its authority by approving mifepristone under the accelerated approval 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 say in their complaint.
Mifepristone, when used in combination with the stomach ulcer drug misoprostol, has been shown to be safe and effective in terminating a pregnancy within 10 weeks of a woman’s last period.
The conservative argument that mifepristone is unsafe runs counter to the guidance of obstetricians and gynecologists, as well as the scientific community at large.
A 2012 meta-analysis of 87 clinical trials published in the journal Contraception stated that medical abortion is generally safe.
In the study, serious complications, such as heavy vaginal bleeding, pelvic pain or infection requiring hospitalization, occurred in less than 0.3 percent of patients.
Studies show that mifepristone is safer and send fewer people to the emergency department than Tylenol and Viagra.
The FDA, in response, saying of a ruling in favor of the anti-abortion plaintiffs: ‘It would upend the status quo and the trusted interests of patients and doctors who depend on mifepristone, as well as the companies involved in the distribution of mifepristone. The balance of actions and the public interest also strongly favor the denial of Plaintiffs’ motion.’
The agency added that by revoking the 2000 approval, the court would set a dangerous precedent.
The agency said: “More broadly, if long-standing FDA drug approvals were so easily enforced, even decades after they were issued, pharmaceutical companies could not confidently rely on FDA approval decisions to build the drug infrastructure Americans depend on to treat a variety of health conditions.’
‘A preliminary injunction would interfere with a decision by Congress to charge the FDA with responsibility for ensuring the safety and efficacy of drugs. In performing this role, the FDA applies its technical expertise to make complex scientific determinations about the safety and efficacy of drugs, and these determinations deserve considerable deference.’
