Access to the abortion drug mifepristone is at risk because of a lawsuit by the legal advocacy group Alliance Defending Freedom in Texas, which is challenging the FDA's 23-year-old approval of the drug by claiming that it was rushed and that the drug is unsafe. Unsurprisingly, it filed this lawsuit in Amarillo, Texas, to guarantee getting Trump-appointed US District Judge Matthew Kacsmaryk, who sided with the plaintiffs and suspended the FDA's approval.
Since that decision, this situation has only gotten more complicated, with national consequences. Here's what you need to know.
What is mifepristone?
Mifepristone blocks the hormone progesterone., which causes the uterus lining to break down, after which the pregnancy cannot continue. This drug is the first step in the process of medication abortion, after which misoprostol is used, which causes the uterus to empty. This process is used up to ten weeks after the first day of one's last menstrual period and makes up over 50% of all abortions in the United States.
Large doses of misoprostol without mifepristone can also successfully end an early pregnancy but will often cause more discomfort and pain to the patient. When combined, the required dosage of misoprostol is lower and thus makes the process easier and more comfortable.
Mifepristone has been used in America for over two decades, and studies have shown that major adverse reactions are exceedingly rare. According to the American Medical Association, the drug is one of "the most studied medications prescribed in the nation," whose "scientific evidence supporting its safety and efficacy is overwhelming." The AMA states that the "risk of patient death from medication abortion is near zero."
Who is Judge Kacsmaryk?
Judge Kacsmaryk was nominated by President Trump in 2017 and then sworn in as a district Judge of the US District Court of the Northern District of Texas in 2019. From 2014 to 2019, he acted as deputy general counsel for the Christian conservative legal group First Liberty Institute. Since 2012 he has been a member of the Federalist Society, a conservative and libertarian legal organization whose members hold positions of power throughout our government. Six of the nine Supreme Court Judges are current or former members.
Throughout his career, Judge Kacsmaryk has argued against LGBTQ+ and reproductive rights. His writings include calling homosexuality "disordered" and being Trans "delusional." From day one of his career, he has opposed Roe v. Wade, and in 2017 wrote an article arguing that doctors with religious objections should not be required to treat Trans people. Judge Kacsmaryk, for the past three years, has opposed the Biden administration's policies, such as his 2022 vacating protections for Trans workers.
What is the lawsuit?
The case is Alliance of Hippocratic Medicine (AHM) v. U.S. Food and Drug Administration (FDA). AHM, an anti-abortion organization incorporated in August 2022, is being represented by the Alliance Defending Freedom. AHM claims that the FDA, in its process to approve mifepristone, "disregarded the substantial evidence that chemical abortion drugs cause more complications than even surgical abortions." The suit is filled with false claims about the over-two-decades-old drug and the effect of chemical abortion on women's bodies.
The defendants argued that the FDA approval in 2000 followed standard procedure. They cited years of scientific studies that show that complications are rare and that less than 1% of patients require hospitalization. Compared to other common medications, mifepristone is safer than Tylenol, penicillin, and Viagra.
When the judge sided with the plaintiffs, he stated that the FDA did not consider the risks associated with the drug and the "intense psychological trauma and post-traumatic stress women often experience from chemical abortion."
How potentially forcing women to use more painful forms of medication abortion or to get a surgical abortion outside of their homes is less traumatic was not explained.
This is the first time a district judge has ruled to suspend the approval of a drug, and it could be argued that it is not in the purview of lower courts to do so. The FDA must follow the rules set by Congress, but depending on the Supreme Court's decision, that could change.
What are the ramifications?
Within an hour of Judge Kacsmaryk's ruling, a Washington judge, Thomas O. Rice, who President Obama appointed, made a ruling to protect access to the drug, which created a conflict that forced the issue to be brought to the Supreme Court.
Justice Samuel Alito issued a temporary stay, meaning that the drug will remain available until the Supreme Court's decision on April 21. If the court upholds Judge Kacsmaryk's decision, this could affect access to this drug and open the door to further restrictions on abortion medication, such as the ability to receive it in the mail.
The ramifications of whatever decision comes this Friday could be vast. It could not only restrict access to abortions in blue states but also create a dangerous precedent concerning access to any medication. If a lawsuit filled with unscientific claims can just be shopped around to the right judge, other medications could also be restricted.
Supreme Court to decide on mifepristone lawsuit: How judge shopping and ignoring science may set a new national precedent
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