Missouri Attorney General Catherine Hanaway is asking a federal court to roll back the U.S. Food and Drug Administration’s recent decision to approve a new generic brand of mifepristone, her first foray into a lawsuit filed by her predecessor to limit access to medication abortion nationwide.
In September the FDA approved a new generic form of mifepristone, bringing the total approved manufacturers to three.
This federal approval, which drew the ire of anti-abortion groups, came after Health and Human Services Secretary Robert F. Kennedy Jr. promised U.S. Sen. Josh Hawley, a Republican from Missouri, that his agency would conduct a “complete review” of mifepristone.
“If the FDA is reevaluating the brand-name drug’s safety, then it needs to stop rubber-stamping new mail-order generic versions before more women are hurt,” Hanaway said in a statement Thursday.
The new FDA approval will make medication abortions more accessible, Hanaway argues.
“The supply of mifepristone will increase, the cost will decrease and the number of chemical abortions will rise… across the nation,” the new court filing reads.
The lawsuit demands the federal government restore its previous restrictions on mifepristone by requiring three in-person doctor visits, reducing the gestational period during which the medication can be taken from 10 weeks to seven and rolling back recent federal policy that allowed for the mailing of mifepristone and allowed for prescriptions to be made online or through pharmacies.
Medication abortion — used in about two-thirds of abortions in the U.S. — requires two kinds of pills. The first, mifepristone, causes the embryo or fetus to stop growing and detach from the uterine wall, ending the pregnancy. The second, misoprostol, causes the uterus to expel the pregnancy tissue. Both medications are also used to treat miscarriages.
“For Missouri and other states with strong protections for unborn life and maternal health, the widespread mail-order distribution of mifepristone directly undermines state law and burdens state hospitals, emergency rooms, and taxpayers,” Hanaway said in her statement Thursday.
The FDA states that mifepristone is safe to use if taken as directed in the first trimester of pregnancy.
Bleeding and cramping are expected side effects. More rarely, there can be hemorrhaging and infection. Those prescribed mifepristone are urged to call their doctor if they experience heavy bleeding, abdominal pain or a fever. This guidance also applies to those who recently underwent surgical abortions, experienced miscarriages or delivered a baby.
Since the medication was approved for use nearly three decades ago, the FDA has reported only 32 deaths associated with mifepristone. The report evaluates data from 5.9 million women who took mifepristone between 2000 and 2022. Of the three dozen deaths, 11 were the result of sepsis, 20 were homicides and two were suicides.
Hanaway stepped into the legal challenge to mifepristone first filed by her predecessor, Andrew Bailey. The federal lawsuit challenging the safety of mifepristone was taken up by the attorneys general of Missouri, Idaho and Kansas last year after the U.S. Supreme Court rejected the original lawsuit, saying the anti-abortion doctors and medical organizations in Texas who brought the original case didn’t have the standing to sue.
The case was recently moved from a federal court in Texas to the eastern district of Missouri in St. Louis after a federal judge in Texas said he no longer had jurisdiction over the plaintiffs. A court date has not yet been set.
Despite voters enshrining the right to abortion in the Missouri Constitution last year, medication abortion is inaccessible through Planned Parenthood clinics in Missouri.
A Jackson County judge is currently weighing whether to keep in place two state regulations that Planned Parenthood says are preventing its providers from performing medication abortions in Missouri.