A federal judge in Texas will decide whether the abortion pill, mifepristone, should be restricted or taken off the market.
U.S. District Judge Matthew Kacsmaryk, who heard arguments from both sides during a hearing in Amarillo on Wednesday, told lawyers he would issue a ruling “as soon as possible,” the Associated Press reported.
The hearing is part of a civil lawsuit filed in November against the U.S. Food and Drug Administration and the U.S. Department of Health and Human Services by the Alliance for Hippocratic Medicine, a coalition of pro-life medical groups and physicians that “upholds and promotes the fundamental principles of Hippocratic medicine,” according to its website. (pdf)
“Today we asked the court to put the health and wellbeing of women and girls first by undoing the harms that the FDA [U.S. Food and Drug Administration] has caused by illegally approving dangerous chemical abortion drugs and removing necessary protections,” Alliance Defending Freedom (ADF) Senior Counsel Erik Baptist said in a statement on Wednesday following the hearing. ADF represents the plaintiffs, Alliance for Hippocratic Medicine, in the case.
The plaintiffs’ lawyers had filed a motion seeking a preliminary injunction to remove mifepristone from the market, arguing the drug is unsafe and that it was improperly approved more than 20 years ago.
Justice Department Lawyer Julie Strauss Harris for the FDA asked the court to deny the motion claiming the drug is safe and taking it off the market would cause harm to patients who rely on the drug, NPR reported.
About the Drug
In 2000, the FDA approved the chemical abortion pill for ending pregnancies at up to seven weeks gestation or less. In 2016, the FDA extended the use in pregnancies at up to 10 weeks gestation.
Since the U.S. Supreme Court overturned its 1973 Roe v. Wade decision, the abortion drug has been increasingly prescribed and has become the most common method of abortion in the United States.
A policy implemented by the Biden administration allows the drugs to be distributed by mail.
Last month, Attorney General Ken Paxton joined a Missouri-led multistate coalition warning pharmacies, including CVS, Walgreens, and others, not to send abortion-inducing drugs via mail.
“Many people are not aware that federal law expressly prohibits using the mail to send or receive any drug that will ‘be used or applied for producing abortion,'” the letter reads, adding that doing so is a federal crime. (pdf)
How the Drug Works
First, the woman takes mifepristone orally. The drug cuts off the supply of progesterone to the uterus. Progesterone is necessary for the baby to continue developing and growing.
Next, 24–48 hours later, the woman is instructed to take a second drug, misoprostol, to induce labor and delivery of the baby.
Between January and October 2022, there were 17,203 abortions recorded by Texas Health and Human Services.
Of those, 11,719 were chemical abortions.
Each side had two hours to present their arguments during Wednesday’s hearing.
Lawyers for the Alliance for Hippocratic Medicine argued that the FDA had overlooked the harmful complications of chemical abortion drugs.
“The [FDA] ignored the potential impacts of the hormone-blocking regimen on the developing bodies of adolescent girls in violation of the Pediatric Research and Equity Act (PREA),” according to court documents. “And the FDA disregarded the substantial evidence that chemical abortion drugs cause more complications than even surgical abortions.”
One study found that more than 35 percent of women who took the chemical abortion drugs visited the ER within 30 days, according to ADF.
The FDA has also reduced the number of required in-person office visits for chemical abortion from three to one, expanded who can prescribe and administer the drugs, and eliminated the requirement for abortionists to report non-fatal complications, the documents state.
ADF lawyers argued that the FDA did not have the authority to grant the drugs’ approval.
It did so based on a regulation that authorizes the “FDA to grant ‘accelerated approval’ of ‘certain new drug products that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit to patients over existing treatments,” according to the documents.
“The plain text is clear it applies to illnesses,” Baptist for ADF argued. “Mifepristone is used to end pregnancies, and pregnancy isn’t an illness.”
Government lawyers said the terms of mifepristone’s use were replaced more than 10 years ago by subsequent FDA programs created by Congress, making the argument irrelevant.
“An injunction here would interfere with the interests of every state in the country,” Straus Harris said.
At one point during the hearing, the judge said that the ADF lawyers’ outline for the order of their arguments “tracks the elements for an injunction nicely.”
“Any relief you grant must be complete” and apply nationwide, Baptist said. “The harms of these abortion drugs know no bounds.”
If the judge rules in favor of the Alliance for Hippocratic Medicine, the Justice Department would file an appeal and likely seek an emergency stay while the case proceeds.
Kacsmaryk was appointed as a U.S. district judge of the Northern District of Texas by former President Donald Trump in 2019.