Missouri Attorney General Catherine Hanaway is challenging the FDA’s recent approval of a new generic form of mifepristone, a key medication used in abortions. The lawsuit seeks to restore previous restrictions, including in-person doctor visits and a shorter window for taking the drug.
Hanaway’s legal action follows a similar lawsuit initially filed by her predecessor, Andrew Bailey, aimed at limiting access to medication abortion nationwide. In September, the FDA approved the new generic, bringing the total number of approved manufacturers to three.
Hanaway argues that this approval will increase the supply of mifepristone, lower its cost, and lead to more chemical abortions across the U.S. “If the FDA is reevaluating the brand-name drug’s safety, it should not approve new mail-order generics before more women are harmed,” she said in a statement on Nov. 20.
The lawsuit asks the federal government to reinstate prior restrictions. These include requiring three in-person doctor visits, reducing the period during which mifepristone can be taken from 10 weeks to seven, and reversing policies that allow the drug to be prescribed online or mailed to patients.
How Mifepristone Works
Medication abortion accounts for about two-thirds of U.S. abortions. It involves two medications:
Mifepristone: Stops the embryo or fetus from developing and detaches it from the uterus.
Misoprostol: Causes the uterus to expel the pregnancy tissue.
Both drugs are also used to treat miscarriages. The FDA states that mifepristone is safe when used correctly during the first trimester. Common side effects include bleeding and cramping, while rare complications can include severe hemorrhaging or infection. Patients are advised to contact a doctor if they experience heavy bleeding, abdominal pain, or fever.
Since its approval nearly 30 years ago, the FDA has reported only 32 deaths among 5.9 million women who took mifepristone between 2000 and 2022. Of these deaths, 11 were from sepsis, 20 were homicides, and two were suicides.
The federal lawsuit was initially filed by anti-abortion doctors and medical groups in Texas, but the U.S. Supreme Court dismissed the case, citing a lack of legal standing. The challenge was then taken up by the attorneys general of Missouri, Idaho, and Kansas. The case was recently transferred from Texas to the Eastern District of Missouri in St. Louis. No court date has been set.
Hanaway emphasized that mail-order distribution of mifepristone undermines state law and burdens hospitals, emergency rooms, and taxpayers in states like Missouri that have strong protections for unborn life.
Despite Missouri voters approving abortion rights in the state constitution last year, medication abortion remains largely inaccessible through Planned Parenthood clinics. A Jackson County judge is currently reviewing whether two state regulations are preventing Planned Parenthood providers from performing medication abortions in Missouri.
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