Update: The judge made his ruling Friday evening and invalidated the FDA approval though the judge stayed his own order for seven days to allow the FDA to appeal. A second federal judge in Washington ordered the FDA to make no changes to the availability of mifepristone. This story appears as originally written below.
A federal district judge in Texas is expected to rule in the coming weeks on whether the abortion drug mifepristone can remain on the market.
The case, Alliance for Hippocratic Medicine v. FDA, was brought to the Amarillo-based federal district court, abortion advocates have said, because the sole federal judge there has ties to Christian-based organizations and has said before that he supports state bans on birth control. The U.S. Supreme Court ruled that states could not ban birth control between married couples in 1965. Seven years later, the court ruled that unmarried individuals also had the right to obtain birth control.
The U.S. District Court Judge in Amarillo, Matthew Kacsmaryk, is an appointee of former President Donald Trump.
Kacsmaryk heard testimony in March and is currently deliberating the case. If the plaintiff’s prevail, the FDA is widely expected to appeal, but the appeal will go to the Fifth Circuit Court of Appeals in Texas, which tends to rule conservatively. When Texas Governor Greg Abbott banned abortion at the beginning of the COVID-19 pandemic, abortion providers sued. The initial court ruling placed a stay on Abbott’s temporary ban but the state then appealed the decision to the Fifth Circuit Court of Appeals, which put Abbott’s ban back into effect.
If the FDA loses in both courts, it would then likely appeal to the U.S. Supreme Court, which overturned Roe v. Wade last year.
Jennifer Dalven, director of the American Civil Liberties Union Reproductive Freedom Project, said through a press conference that if Kacsmaryk rules in favor of the plaintiffs, not only will mifepristone be potentially removed from the market, including in states where abortion is legal like New Mexico, but that this could have wide sweeping impacts for other medicines. She said it would set a precedent in which any group that disagrees with a a medically-approved drug or vaccine that could seek court intervention to remove or prevent it from reaching the public.
The trend toward abortion medication has been on the increase in the U.S. over the 23-year period since the FDA first approved mifepristone for the market in 2000. The Alliance for Hippocratic Medicine argues in its case that the FDA did not study the drug properly before releasing it to the public and, therefore, they claim it should be removed from the market and studied more comprehensively.
Dalven called the lawsuit “baseless” and “unprecedented.” She cited The New York Times, which looked into the issue a few days ago. The Times found that 101 mifepristone studies conducted over 30 years in 26 countries found that the drug is 99 percent effective and safe. The studies varied in sample size, with at least one which studied as many as 19,000 abortion patients.
“It’s safer than Tylenol and Viagra,” Dalven said.
But because of the heated political climate around abortion, the FDA placed barriers around mifepristone when it approved the drug for the market in 2000. Those barriers remained in place for more than 20 years after approval for use.
In addition to the studies,mifepristone is approved by several medical associations including the American College of Obstetrics and Gynecology.
During the COVID-19 pandemic, the ACLU fought to remove the FDA restrictions to mifepristone, which required a pregnant individual to receive the medication at an abortion clinic, instead of through the normal prescription process of picking it up from a local pharmacy. This rule created a barrier in particular for low income and rural individuals who would have to travel hundreds of miles to reach a clinic that provides abortions. Once a person picked up the medication at a clinic, they could leave the clinic to take the medication where they felt most comfortable, including at home.
The court fight to remove those restrictions lasted most of the first two years of the pandemic. The ACLU argued that, during the pandemic, the in-person clinic pickup requirement endangered individuals by forcing them to travel. Not until a year after President Joe Biden took office did the FDA establish a new set of rule-making that ended the requirement.
According to the Pew Research Center, 2020 was the first year that abortion medication accounted for more than half of all U.S. abortions. The FDA approves use of medication abortion up to 10 weeks of gestation.
Dr. Bhavik Kumar, Medical Director for Primary and Transgender Care at Planned Parenthood Gulf Coast in Texas, said during the press conference that, if mifepristone is removed from the market, one protocol could be the use of misoprostol only to continue medication abortion. Currently, mifepristone is part of a two-step regimen. Mifepristone blocks the hormones that support a pregnancy. Misoprostol empties out the uterus.
But Dalven said the immediate impact, if Kacsmaryk rules in favor of the plaintiffs, will be “significant chaos.”
“There’s going to be a lot of uncertainty and fear among providers and patients,” Dalven said.
Kumar said there will likely be other unintended consequences, such as how the ruling will impact supply chains and force more patients to obtain surgical abortion, which is more costly.
Governor Michelle Lujan Grisham, who signed on Wednesday the second of two major pieces of state legislation into law protecting abortion access and gender-affirming healthcare, joined an alliance of 20 governors representing abortion safe-haven states last month.
Maddy Hayden, Lujan Grisham’s spokesperson, said the governor is in conversation within the alliance and elsewhere about this new strategy by anti-abortion groups to restrict abortion access.
“The governor is absolutely involved in planning conversations at the state and national level, including within the recently assembled Reproductive Freedom Alliance to prepare for any impacts caused by the court’s decision,” Hayden said.
But, Dalven said the ruling will be nationwide, and thereby will impact states such as New Mexico, which has no barriers to abortion.
“It’s not at all clear that states will have the capacity to protect this drug,” Dalven said.