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 reversing the Food and Drug Administration’s (FDA) approval of mifepristone, which is being marketed as Mifeprex, which would halt its use statewide.
Mifepristone is half of the two-drug cocktail — along with misoprostol — that allows a woman to end her pregnancy in the comfort of her own home.
The pills gained traction after the US Supreme Court ruled last summer to overturn Roe v. Wade. For women in the 24 states where abortion is either illegal or severely restricted, this may be their only refuge.
A majority of US abortions are performed with this drug. The drugs recently became available in pharmacies across the US — even in states where abortion is banned — under a new Biden administration order.
Mifepristone, unlike its counterpart misoprostol, is only approved for abortion. It was approved in 2000. About half of abortions are performed using the two-pill system
Abortion rights advocates rallied Wednesday during the hearing outside the J Marvin Jones Federal Building and Courthouse in Amarillo, Texas
The case in question is the Alliance for Hippocratic Medicines v. the US FDA, which was first filed late last year to challenge the FDA’s approval of Mifeprex in 2000.
It was submitted by the anti-abortion group Alliance Defending Freedom (ADF).
The group argues that the drug was not properly tested for safety when it was approved 23 years ago.
The ADF also argues that the drug’s approval is nullified by the Comstock Act of 1873 – which bans the sale of immoral or indecent products through the mail.
They argue that the law should make it illegal to ship the drug through the mail and the FDA’s authorization to do so should be removed.
Judge Kacsmaryk, who was appointed by President Trump and confirmed in the Senate by a 52-49 vote in 2019, is known as a pro-abortion advocate and is expected to rule in favor of the group.
The ruling would have far-reaching consequences for American women, even in states where abortion remains legal.
A motion to revoke FDA approval would almost certainly be immediately challenged by abortion rights activists.
But the Fifth Circuit Court of Appeals, which would consider the case, is also politically very 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
Because of the Supreme Court’s 2021 decision in Dobbs v. Jackson, which removed federal protection for the procedure, drug-induced abortions account for the majority of abortions performed today.
The drug has been FDA approved for over two decades following rigorous rounds of safety and efficacy testing and 12 years of safe use in France.
The ADF on the Alliance for Hippocratic Medicine side and anti-abortion health care providers argue, “The FDA failed America’s women and girls when it put politics ahead of 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 has included six individual regulatory actions. The plaintiffs challenged those six FDA actions and are asking that the court declare, vacate, and set aside them illegal.’
Organizers of the women’s march said they intend to hold a “kangaroo court” outside the courthouse in Amarillo, Texas, where protesters will be dressed in costume to indicate the case is based on fraudulent claims
They allege that the FDA abused its authority by allowing mifepristone through the expedited route.
This is 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 the FDA’s approval pathway required it to consider pregnancy a “disease” for which the drug would provide “significant therapeutic benefit.”
“But pregnancy is not an illness,” the plaintiffs state in their lawsuit.
Mifepristone, when used in combination with the stomach ulcer drug misoprostol, has been shown to be safe and effective in terminating a pregnancy within about 10 weeks of the woman’s last menstrual period.
If the Texas judge rules in favor of the conservatives, 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 that could take years.
Professor Rebouché told : “The bigger problem is that it’s still a federal court telling a federal agency, the expert on drug safety and efficacy, that it incorrectly approved a drug 23 years ago.
“We have never seen a court step in to try and reverse a drug approval process decades after the drug was on the market. We certainly haven’t seen it for a drug as safe as mifepristone.’
Conservatives’ argument that mifepristone is unsafe goes against the advice of obstetricians and gynecologists, as well as the broader scientific community.
A 2012 meta-analysis of 87 clinical trials published in the journal Contraception confirmed that medical abortions are generally safe.
In the study, less than 0.3 percent of patients experienced serious complications, such as severe vaginal bleeding, pelvic pain, or infections that required hospitalization.
Studies show that mifepristone is safer and sends fewer people to the emergency room than Tylenol and Viagra.
Abortion rights advocates gather in front of the Texas courthouse on Wednesday
The FDA then said of an anti-abortion ruling: “It would upend the status quo and the legitimate interests of patients and physicians who rely on mifepristone, as well as companies involved in the distribution of mifepristone.” The consideration of equity and the public interest therefore also speak strongly for the rejection of the plaintiffs’ application.’
The agency added that by overturning the 2000 permit, the court would set a dangerous precedent.
The agency said, “More generally, if long-standing FDA drug approvals were issued so easily, drug companies could not confidently rely on FDA approval decisions, even decades after they were granted, to develop the drug infrastructure Americans depend on to a variety of health conditions.’
“An injunction would interfere with Congress’ decision to give the FDA responsibility for ensuring 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 deserve significant recognition.’