On Friday, April 7, U.S. District Judge Matthew Kacsmaryk upended basic legal norms in his decision regarding the case Alliance for Hippocratic Medicine v. Food and Drug Administration (FDA) by undermining the FDA’s authority to determine whether drugs are safe and effective. Judge Kacsmaryk’s halting of the decades-long approval of mifepristone in an attempt to eradicate abortion access underscores not only a growing politicization of the judiciary but also a shift toward the politicization of medicine. The judge delayed the effective date of this decision by seven days allow the U.S. Department of Justice (DOJ) to file for emergency relief at the 5th Circuit. This means that mifepristone, even under the judge’s order, is still approved in the U.S. until at least April 14.
Adding to this upheaval, Kacsmaryk’s decision coincided with a conflicting decision in a separate federal case, in Washington state, which ordered that the status of mifepristone must remain unchanged in the 17 states, as well as the District of Columbia, that filed suit. This has created a high-stakes clash between district courts, with critical health care in the balance.
Mifepristone has been proven safe and effective
Mifepristone is the only FDA-approved option for the first drug in a two step-regimen for medication abortion. Medication abortions currently account for more than half of all abortion care in the United States. In addition to being approved for abortion, the drug is used to treat other medical conditions such as Cushing syndrome and diabetes as well as miscarriages.
It is absolutely clear that mifepristone is safe: The FDA has evaluated its safety at least four times in the more than 22 years it has been on the market. Approximately 5.6 million women in the United States have used mifepristone and its safety record is exceptional. In fact, Tylenol causes more serious complications than mifepristone.
Within hours of Judge Kacsmaryk’s ruling, the DOJ announced it would appeal to the 5th Circuit. Given the two conflicting opinions on mifepristone, the question of whether mifepristone will remain approved is likely to go quickly to the U.S. Supreme Court.
There are myriad egregious aspects of Judge Kacsmaryk’s opinion that are crucial for the public to understand—and it’s essential to understand what comes next.
The political nature of Judge Kacsmaryk’s decision
Judge Kacsmaryk’s order was complex and invoked a variety of arguments in attempts to legitimize the court’s decision. Kacsmaryk’s language—a far-right Trump appointee—was designed to shame those who chose abortion. It also parroted far-right talking points on physicians who provide abortion care. In fact, the judge even seems to suggest full legal rights should begin at the point of conception—a state of affairs that could operate to make a woman’s rights and livelihood second to her pregnancy.
Personal politics seem to inform the type of language the judge uses throughout his order. This is alarming given the blow it represents to the idea of an impartial judiciary. However, this is not surprising, as the judge’s far-right activism and commitment to dismantling abortion rights is no secret. However, the judge’s willingness to disregard medical standards and scientific expertise is particularly important to understand in the short-term as the appeals process begins:
- The order found that FDA’s initial 2000 approval of mifepristone was incorrectly decided under what is referred to as Subpart H. Subpart H is an approval process (that has since been updated) for new drugs that treat a “serious or life-threatening illness” and provide a “meaningful therapeutic benefit.” The judge, who has no medical expertise, held that pregnancy is not the former and mifepristone does not provide the latter. This decision contradicts not only the FDA’s determination but also the opinion of major medical groups.
- Even though the judge has virtually no experience in scientific matters—let alone clinical procedures for drug safety—he held that the clinical trials the FDA has taken to determine the safety and efficacy of mifepristone were insufficient. He essentially made up a new standard for drug approvals that both the FDA and scholars have noted as being unnecessary and that would fail to provide a valid risk-safety assessment of the drug.
- Because the order seeks to invalidate the original approval of mifepristone, later approvals of generic versions as well as updated protocols for prescribing and dispensing the medication are also invalid.
It is critical not to downplay the importance of the judge’s willingness to subvert the FDA’s approval process in this manner. In the long term, if allowed to stand, such a precedent could have consequences for medications well beyond mifepristone.
The FDA currently holds authority for ensuring that all drugs approved in the United States are subjected to a rigorous, scientific standards for safety and efficacy. Allowing the judiciary to overturn drug approvals would undermine the independence of this system. A less predictable, highly politicized drug approval process could discourage pharmaceutical companies from developing new drugs. It would also mean that already-approved drugs that Americans rely on for prevention or treatment could be disrupted at the whims of judges.
The Comstock Act and 2021 In-Person Mailing Requirement for Mifepristone
The order also spoke to the Comstock Act from 1873. The act prohibited (among many other provisions) the mailing of essentially anything related to abortion care, including medications. In 2022, the DOJ released a memo that explained the limited reach of Comstock—which a robust line of caselaw established as applying only to illegal activity—and that medicines used to end pregnancies, such as mifepristone, can be mailed for entirely legal reasons even in states that have banned abortion. However, the judge overrode the entirety of the DOJ’s memo by stating that the FDA’s 2021 decision to lift the in-person dispensing requirement of mifepristone—allowing it to be dispensed by mail or mail-order pharmacy—violated the Comstock Act. Though the impact of the order on this point is unclear, it speaks to the extreme lengths the far right is willing to take—such as searching Americans’ mail for medicines—to enforce abortion bans.
The order will result in medical and legal chaos
Judge Kacsmaryk’s order is being appealed by the DOJ to the 5th Circuit Court of Appeals. How long the 5th Circuit will take to decide—and how it will decide—is unclear. In addition, while the 5th Circuit appears to be the court most likely to rule next on the question of mifepristone’s availability, the conflicting federal decision out of Washington state makes it all the more likely the Supreme Court will be asked to intervene in the near future.
From a practical perspective, even with the promise of a stay pending appeals, the recent legal developments will only exacerbate the chilling effects and confusion that already exist with abortion care. Already, doctors and pharmacists report widespread confusion on how—and whether—to provide certain treatments in states where abortion is banned. This state of affairs will now likely only worsen. And, if mifepristone is ultimately restricted—even for a period of time— states with fewer restrictions on abortion will have to accommodate an ever-increasing influx of patients from other states seeking in-clinic procedures abortion.
Recognizing this—and despite the ongoing legal chaos—it will be essential to look for ways to blunt the mass confusion caused by the two decisions, even as the appeals process gets underway and the FDA evaluates its options to help ensure access to safe medicines while still complying with the law. As a baseline, policymakers at all levels, in partnership with trusted community organizations, must ensure that all patients and health care providers know their rights on how to access or provide care.
In addition, in the weeks ahead, policymakers must explore legislation to protect medicine from improper political—and, as appropriate, judicial—interference.
Judge Kacsmaryk’s decision reveals that his order is not rooted in concerns about the safety of mifepristone but, instead, a desire to restrict abortion access and impose an extremist agenda on every person in America. The appeals courts have a critical choice before them. The impact on abortion care—as well as medicine overall—is clear if the judge’s reasoning is allowed to take effect.
Furthermore, the rhetoric in Kacsmaryk’s opinion speaks to the deep politicization in the federal judiciary that must be addressed regardless of the outcome of the ongoing litigation of mifepristone. Women and all other Americans deserve a judicial process in which decisions are based on law and facts. Determinations of drug safety and efficacy must be protected from politicization.
Judge Kacsmaryk’s baseless order should be stayed at all points of appeal and ultimately overturned.