When federal Judge Matthew Kacsmaryk suspended the Food and Drug Administration (FDA) approval of the drug mifepristone on April 7, he significantly jeopardized access to abortion. In addition to dealing an immediate blow to accessing an essential and time-sensitive health care service, this decision also upended a drug approval system that for decades has been based on scientific evidence and expert medical opinions. Kacsmaryk overshadowed a trusted system with the specter of a drug supply shaped by judicial fiat.
The lawsuit was filed in the U.S. District Court for the Northern District of Texas, but the April 7 decision pertains to mifepristone’s FDA approval nationwide. Kacsmaryk gave seven days for the government to appeal before the decision takes effect, and the fact that a federal judge in Washington state issued a conflicting ruling—ordering that FDA retain mifepristone access in the jurisdictions that brought that suit (17 states and the District of Columbia)—makes it possible the appeal will go directly to the Supreme Court rather than the Fifth Circuit. If a higher court fails to overturn Kacsmaryk’s ruling, this decision opens a Pandora’s box that could allow the availability of every drug in the U.S.—from vaccines to painkillers—to be based on politics rather than science.
This decision raises alarm for its enormous potential impact on women’s—and other individuals’—health, as well as the lasting effect it may have on the federal regulatory process. For mifepristone, the science on its safety and efficacy was substantial when FDA first approved the drug in 2000, and this evidence has only grown in the intervening years. (The New York Times recently collected and analyzed 101 studies on mifepristone, and the vast majority found no serious complications in more than 99 percent of those who took the drug.) However, from the drug’s initial approval process to the present, politically motivated attacks have threatened its availability and use.
In Alliance for Hippocratic Medicine v. FDA, antiabortion plaintiffs claimed FDA’s 2000 approval of mifepristone—which, used in combination with misoprostol, accounts for approximately half of all U.S. abortions—was improper because the agency fast-tracked it under a regulatory provision known as Subpart H. Although Subpart H does allow for fast-tracking certain drugs, FDA didn’t use it for that purpose with mifepristone. By the time FDA approved mifepristone, more than a decade of evidence demonstrated its safety and effectiveness. During the approval process, FDA used Subpart H to impose additional restrictions on how the drug could be dispensed, including requiring providers and patients to sign agreements before using it. Extensive evidence has demonstrated those restrictions are unnecessary for safety, and FDA has since relaxed some of them.
Medication abortion is safe, effective and very common. There were 492,210 medication abortions in 2020, representing 53 percent of all abortions in the U.S. The rate of serious adverse events is significantly lower than in continuing a pregnancy to term, especially for Black women, whose maternal mortality rate is more than double white women’s. Furthermore, in a post–Dobbs v Jackson Women’s Health Organization environment, where clinics in a dwindling number of states must care for clients from across the country, offering medication abortion has allowed providers to serve more patients than they could via procedural abortions alone.
Following the Kacsmaryk decision, some providers might keep offering the mifepristone-misoprostol combination for medication abortion unless and until FDA formally withdraws its approval. Many will switch to a misoprostol-only regimen that’s used in countries where mifepristone isn’t readily available. This alternative regimen requires different dosing and timing, placing the onus on already burdened medical providers to change their clinical practices.
Updating procedures and trainings will mean taking time away from patient care. Some providers who currently offer medication abortion might simply stop doing so, as this legal issue adds to the growing toll of harassment and attacks they’ve faced in recent years; threats to abortion providers’ physical safety—which include arson and murder—had already increased by 125 percent from 2019 to 2020, even before the Dobbs decision. FDA can engage in the unnecessary exercise of reconsidering mifepristone in light of the decision, but in the meantime access to medication abortion is likely to drop.
Despite providers’ best efforts, after this decision we’re likely to see still more of what we started seeing in the immediate wake of Dobbs: people will have to spend more money, travel farther, and face more job and childcare challenges in order to get abortions. Those with the fewest resources—who, because of systemic racism, are disproportionately likely to be Black and brown women—will be unable to do so and will be forced to bear children against their will. Given this country’s shameful maternal mortality rate, this is quite literally a life-and-death decision.
Judge Kacsmaryk, who previously worked for a conservative Christian advocacy group, has substituted his judgment about mifepristone for that of the FDA experts who reviewed it, with severe consequences for public health. If his decision stands, no drug is safe from such politically motivated meddling. Drugs used in gender-affirming care will probably see court challenges, and contraception and routine vaccinations could also come under threat. Furthermore, public erosion of confidence in our system of government, already well on its way, will get a big push. FDA has been part of the regulatory system protecting public health for more than a century, and has a strong record of basing decisions on the available science and research at the time. If a single judge can now overturn a decision that was based on research and expertise, then the safeguards we count on are only dependable until a few individuals decide to take them away.
Access to reproductive health services already looks dramatically different across the U.S. than it did a year ago, but the damage from this decision could spread far beyond the critical issue of abortion. A higher court should overturn Judge Kacsmaryk’s misguided decision and prevent politics from overriding science-based decision-making.
This is an opinion and analysis article, and the views expressed by the author or authors are not necessarily those of Scientific American.
