As the number of states with abortion bans has grown in the wake of Dobbs, access to medication abortion has become increasingly critical to reproductive rights and access to care. The ongoing case challenging the Food and Drug Administration’s (FDA) approval of mifepristone, Missouri et al. v. Food and Drug Administration (previously Food and Drug Administration v. Alliance for Hippocratic Medicine), threatens to significantly undermine that access.
Background on Mifepristone REMS Requirements
In 2000, the FDA approved the medication mifepristone, as a part of a two drug-regimen (alongside misoprostol) for use in terminations of pregnancies up to seven weeks gestation (later revised to up to 10 weeks).The FDA also imposed a series of regulations governing the dispensation of mifepristone (under what is known as the Risk Evaluation and Mitigation Strategies (REMS) program), including requiring that: (1) mifepristone only be dispensed in a hospital, clinic, or under the direct supervision of a certified medical provider to the patient in person; (2) the dispensing physician be certified by the medication’s distributor; and (3) patients had to sign a FDA-approved Patient Agreement Form before being prescribed the medication. These requirements were imposed despite substantial evidence demonstrating the safety of mifepristone and the lack of medical necessity for imposing such restrictions; worse, the REMS requirements significantly curtailed access to care.
During the COVID-19 pandemic, the FDA modified the REMS for mifepristone and removed the in-person dispensing requirement. In 2023, the FDA permanently removed the in-person dispensing requirement, and created a pharmacy certification, which allows retail pharmacies (like CVS and Walgreens) to dispense mifepristone with a valid prescription from a health care provider. The removal of these REMS requirements helped alleviate some of the impact caused by increased attacks on abortion access due to the Supreme Court’s 2022 Dobbs decision. Indeed, medication abortion rose significantly in 2023, demonstrating how essential mifepristone is to reproductive health care. Seeing this landscape, anti-abortion activists and politicians began to increasingly target medication abortion, including through these lawsuits against the FDA.
What Has Happened in Litigation Against the FDA and Mifepristone So Far
The Alliance for Hippocratic Medicine (AHM) filed a lawsuit in November 2022, challenging the FDA’s original approval of mifepristone and the subsequent REMS updates that made the medication more accessible. AHM argued that the FDA did not properly consider the physical, psychological and safety concerns of the medication in their initial approval of mifepristone or their updated REMS standards. Although numerous studies have concluded that mifepristone and medication abortion in general are safe and effective, the Supreme Court heard oral arguments on the case on March 26, 2024. On June 13, 2024, the Supreme Court held that AHM did not have standing to bring the case. AHM argued they had the ability to challenge the FDA’s approval of mifepristone because as doctors they could “potentially” have to treat patients who were experiencing complications from mifepristone. The Supreme Court held that the “potential” of treating patients experiencing complications from mifepristone was not a concrete enough injury and therefore, AHM did not suffer an injury from the FDA’s approval of mifepristone and had to be removed from the lawsuit.
The case was then sent back to the lower court, the District Court for the Northern District of Texas Amarillo Division, which is where Judge Matthew Kacsmaryk sits. Subsequently, three states – Idaho, Kansas and Missouri – intervened (in other words, added themselves as plaintiffs, even though they were not part of the original lawsuit) to preserve the case and prevent access to mifepristone.
On January 16, 2025, Judge Kacsmaryk issued an order allowing these three states to continue as plaintiffs and file an amended complaint asserting the injuries they suffer from the FDA’s approval of mifepristone. These states’ primary argument is that their state Medicaid program will likely have to cover the cost of treating patients who have experienced complications from mifepristone. Given the extensive evidence of the medication’s safety, this argument seems just as speculative and improbable as AHM’s – and the states’ standing claim should have been rejected by Kacsmaryk, too. As disturbing as this is, it is one of the states’ secondary arguments that are especially alarming and deserving of more attention.
The Disturbing Pronatalist Arguments In the Newest Round of Litigation
“Defendants’ efforts enabling the remote dispensing of abortion drugs has caused abortions for women in Plaintiff States and decreased births in Plaintiff States. This is a sovereign injury to the State in itself.”
— Amended Complaint in Missouri et al. v. Food and Drug Administration (referring to decreased birth rates due to the availability of medication abortion)
One disturbing argument that these three states put forth is that the FDA’s approval of mifepristone injures them due to the potential loss in population and decreased number of births that could happen as a result of abortions. The states argue that access to mifepristone (and medication abortion in general) could therefore cause “diminishment of political representation and loss of federal funds.” The argument these states are making is problematic for a multitude of reasons, but two are especially egregious.
First, the argument that access to mifepristone and medication abortion in general harms states due to decreased population is a problematic pronatalist idea. Pronatalism is a policy of encouraging people to bear children, in order to preserve “culture” and prevent the breakdown of economies. Operating just underneath the surface – and sometimes right at the forefront – of these policies are racist and ableist ideas about what kinds of families, cultures and societies are desirable and worthy of being protected and promulgated.
Pronatalism is not a new philosophy; nor is it new to blame abortion for declines in population growth or other policies tied to pronatalism. Since abortion was constitutionally recognized in Roe v. Wade, politicians have used abortion as a scapegoat to blame for reduced low-wage workforce, and to justify cuts to social safety net programs. Abortion has been painted as a societal evil because it allows for the termination of white, middle to upper class, nondisabled children, which pronatalists argue are essential to maintaining culture and society. Pronatalism is also deeply misogynistic because it only places value on women in their capacity as mothers and ostracizes women without children. What is new, though, is to see pronatalist arguments like these occupying a central position in a states’ arguments before a court of law.
These states – and others with abortion bans – also fail to provide social safety net programs that allow children and families to thrive such as paid family and medical leave, paid sick days, minimum wage laws above the $7.25 federal minimum and adequate access to maternity care through recognition of midwives and payment of doulas. The pronatalist arguments that these states are putting forward are not only alarming, they are also incredibly hypocritical: while these states are encouraging childbirth, they do little to provide for children or their families once they are born. According to our recently released report, Threats On All Fronts: More Divided Than Ever, all three states (Idaho, Kansas and Missouri) that are suing the FDA have abortion bans that could be categorized as restrictive or most restrictive; at the same time, none of these states have paid family and medical leave policies that would allow parents who have just given birth the opportunity to recover or bond with their newborn. These states – and others with abortion bans – also fail to provide social safety net programs that allow children and families to thrive such as paid family and medical leave, paid sick days, minimum wage laws above the $7.25 federal minimum and adequate access to maternity care through recognition of midwives and payment of doulas. Therefore, while these states argue that they are harmed by declining birth rates due to medication abortion, the truth is that those declines are much more likely caused by the states’ themselves and their policy shortcomings. These states do nothing to provide for children and families currently in existence and will continue to fail individuals who are forced to carry their pregnancies to term due to their abortion bans.
It is imperative that we recognize the increased pronatalist ideology in the new attacks on abortion. Characterizing abortion as a “harm” to the state increases misogyny and refuses to hold states accountable for the failures they have caused by not providing social support to children and families already in existence. For more on how states can better support women and families check out our report Threats On all Front: More Divided Than Ever.
