More than 20 years ago, the Food and Drug Administration (FDA) approved mifepristone, a safe and effective pill used in medication abortions. Today, abortion pills are the most common way to terminate early pregnancy, but an unprecedented case before a federal judge in Texas threatens access to this vital medication and could have dire consequences for bodily autonomy and freedom of choice nationwide – even in states where abortion is protected.
Mifepristone was first developed in the 1980s, and the United States joined more than a dozen other countries that had already authorized the pill when the FDA approved its use in 2000. In the 23 years since mifepristone’s approval, its use has steadily expanded: the FDA extended patient eligibility from 6 weeks to 10 weeks of pregnancy in 2016, and it recently moved to allow the pill to be prescribed by telemedicine, sent by mail, and dispensed by commercial pharmacies with a prescription. Medication abortions now constitute more than half of all abortions in the United States, especially in the first trimester when the vast majority of abortions take place.
Never before has an FDA-approved drug been pulled from the national market after more than two decades of safe usage, but that’s precisely the action a conservative anti-abortion coalition has requested in their lawsuit. Typically, this suit would be quickly rejected; legal experts have widely ridiculed its claims and noted the arguments are baseless. But the plaintiffs strategically engaged in “forum shopping,” filing their lawsuit in the remote Amarillo district in Texas, where procedural rules essentially guarantee that the case would be heard by Trump-appointed Judge Matthew Kacsmaryk, known for his affiliation with conservative religious groups. Despite being on the bench for less than three years, Kacsmaryk has already issued controversial rulings restricting immigration, limiting LGBTQ+ employment protections, and restricting minors’ access to birth control.
The lawsuit is legally dubious: The plaintiffs may not have standing to sue in federal court, and their accusations are contrary to the FDA’s voluminous record justifying every decision it has made on the drug. Mifepristone is one of the most studied medications available in the United States, and recent analysis finds that it “has proven to have an impeccable safety profile – many times safer than common drugs like penicillin or Viagra and eighteen times safer than childbirth.”
Revoking access to mifepristone would have reverberating consequences: it is unprecedented to pull a drug from the market after 23 years of safe and effective use, and such a ruling would radically disrupt our existing health care system. A national injunction against mifepristone will have wide-reaching implications and will impact every single state, including those where abortion is legal and available.
New analysis shows that the decision would have an especially harsh impact on people living in states where medication abortion plays a particularly critical role in ensuring access to care – and many of these states are considered exceptionally protective of abortion rights. And, as is the case with all abortion restrictions, people of color, low income individuals, those living in rural areas, and those without a nearby health care provider are disproportionately harmed by restrictions on medication abortion care.
This case also has the potential to create bad precedent surrounding the FDA’s rigorous approval processes, giving frivolous lawsuits the power to disrupt the health care landscape. Beyond the implications for mifepristone, the outcome of this suit will undermine the FDA’s authority and its reputation as an agency that makes decisions based solely on scientific expertise. Restrictions and bans on mifepristone are not supported by scientific evidence or medical best practices. In fact, leading medical and pharmacy organizations are extremely supportive of the use of mifepristone and have noted that patients’ health is at risk without access to the drug.
Despite the meritless case, there is a strong likelihood that Judge Kacsmaryk will side with the plaintiffs, ruling against the FDA and granting the requested nationwide injunction to pull mifepristone from the national market. It is also possible the judge could rule more narrowly – for example, by reimposing some of the stricter regulations that the FDA has lifted over the years – but this too would significantly limit access to mifepristone. And, importantly, if the judge sides with the plaintiffs at all, this case will have national repercussions, impacting all states and particularly affecting the states where abortion is currently legal and available.
The U.S. Justice Department is vigorously defending the case, and anticipates quickly appealing if Judge Kacsmaryk rules in favor of the plaintiffs. But even if the decision is not legally sound, its route of appeal is to the heavily conservative Fifth Circuit Court of Appeals and then the Supreme Court – neither of which has a record of respecting long standing precedent surrounding abortion access.
Once someone has made the decision to have an abortion, they must be able to access the best care for their circumstances without political interference. Medication abortion can allow patients to control the time and place of their abortions, including the option for them to be supported by loved ones. Surveys show that voters nationwide oppose preventing access to medication abortion, with a solid majority of voters living in states where abortion is illegal or where the state legislature is hostile toward abortion believing that preventing access to medication abortion is a bad outcome of the Dobbs decision.
When the conservative justices overturned Roe v. Wade in June 2022, they claimed Roe had failed to settle the national debate on abortion and that this decision would close the issue. Instead, as the dissent pointed out, the Supreme Court’s holding created “profound legal instability,” upending all precedent around reproductive rights. This case represents only the beginning of an avalanche of attempts to ban abortion nationwide, and we call on the FDA and the Biden administration to take every available action to retain access to medication abortion.
The outcome of this lawsuit does not change the fact that medication abortion is a safe and effective way to end a pregnancy. Even before the Supreme Court overturned Roe, access to reproductive rights was woefully inadequate for many. Everyone deserves access to abortion without the risk of criminalization, and we will never stop fighting for the freedom to fully control our bodies, lives, and futures.
