At Wednesday’s hearing over the fate of mifepristone, conservative lawyers repeatedly insisted that the FDA wrongly greenlighted the abortion medication in 2000 through an “accelerated approval” process. Judge Matthew Kacsmaryk—the far-right Trump nominee whom the plaintiffs hand-picked to oversee the case—evidently agreed: According to reports from the courtroom in Amarillo, Texas, Kacsmaryk continually pressed government lawyers to defend the FDA’s “accelerated approval” of mifepristone nearly 23 years ago. In doing so, he implied that the agency’s allegedly rushed decision might justify pulling the drug from the market today.
This entire argument is built upon a lie. The FDA did not fast-track mifepristone in 2000. Rather, the agency took more than four years to greenlight the drug, doing so only after extensive (and arguably superfluous) examination of its (very minor) risks. When the FDA did finally approve the use of mifepristone, after an unusually thorough review, however, it imposed heightened restrictions on its distribution. It was these extra barriers to mifepristone access that were set up through a process known as accelerated approval. The plaintiffs here exploit confusion about these procedural details to peddle the false narrative that the agency recklessly hastened review of mifepristone. It is an extremely ominous sign that Kacsmaryk appeared to agree with their false history.
These plaintiffs, a group of anti-abortion doctors represented by Alliance Defending Freedom, did not have to work very hard to devise this story: A great deal of media coverage, and even some medical literature, states in passing that mifepristone received accelerated approval because it was ultimately greenlighted under an FDA regulation called Subpart H. The confusion arises from a misunderstanding about how, exactly, the FDA relied on this regulation back in 2000. It is worth recounting the actual events that led up to that point.
In 1996 mifepristone’s “sponsor,” an organization called the Population Council, submitted an application for the drug to the FDA. The agency spent the next four years soliciting voluminous amounts of data, including multiple clinical studies, from the sponsor. (Ironically, you can find all this information in a 505-page appendix submitted by Alliance Defending Freedom, much of which contradicts the group’s own legal and factual claims.) Eventually, Population Council’s data convinced the FDA that mifepristone was both safe and effective enough for use through 49 days’ gestation. After completing review of all data, including clinical trials, the FDA issued an approval letter in the ordinary manner. In keeping with its ultra-cautious approach to the drug, though, the agency decided to continue studying the drug post-approval and to enact additional burdens on its distribution. Only then was Subpart H invoked—at the time, federal law allowed the FDA to impose these rules through Subpart H.
It is true that Subpart H regulations are commonly referred to as “accelerated approval.” It is also true that the FDA often used this process to fast-track drugs for HIV, cancer, and other lethal conditions in desperate need of new treatments. But it is not true that Subpart H existed only to expedite review. This regulation had another purpose: It allowed the FDA to approve a new drug conditionally, set up extra roadblocks around its use, and monitor its impact to ensure safety and efficacy. Indeed, when the agency proposed Subpart H in 1992, some commentators urged it to call the regulation “conditional approval” instead of “accelerated approval,” as the latter term wrongly suggests that all drugs greenlighted under Subpart H were fast-tracked.
When the FDA approved mifepristone on Sept. 28, 2000, then, it invoked Subpart H not to justify a rushed approval process but to justify various restrictions on its dispensation. For instance, the agency required the drug to be dispensed in person by physicians with specific expertise (including the ability to accurately date pregnancies and diagnose ectopic pregnancies). It also mandated strict shipping and tracking requirements; compelled the creation of a complex, closely monitored distribution system; and required providers to report serious adverse reactions. Moreover, the FDA ordered the sponsor to conduct and submit additional studies of the medication post-approval. This was why the FDA invoked Subpart H, not because of any expedited approval, as Judge Kacsmaryk seems inclined to believe.
In the years since, the agency has scrapped some of these requirements, finding them to be pointlessly burdensome. It has also increased the gestational limit from 49 days to 10 weeks, with some providers prescribing it off-label up to 12 weeks (as endorsed by the World Health Organization). After all, mifepristone is safer than Tylenol and Viagra, carrying an astoundingly low risk of death or serious complications. It is also exponentially safer than childbirth. (Just this week, the National Center for Health Statistics reported that maternal death rates in the United States had hit a 56-year high in 2021 with a number that is by far the worst of any peer nation.) More than two decades of real-world data confirm that the FDA was right to approve the drug but wrong to saddle it with so many layers of gratuitous regulations through the use of Subpart H.
And yet, during Wednesday’s hearing, Kacsmaryk reportedly ignored this evidence and fixated on the plaintiffs’ false claim that mifepristone’s review had been “accelerated.” CNN reported that Kacsmaryk grilled government lawyers about the drug’s alleged accelerated approval with evident skepticism. At one point, he pulled out a list of other drugs, like HIV and cancer treatments, that the FDA had approved through an accelerated process. As CNN’s Tierney Sneed noted, the judge then asked how mifepristone “fit” on that list, as if to demonstrate that it had been improperly expedited.
None of this should come as a surprise. Before joining the bench, Kacsmaryk was a culture war lawyer who fought against access to abortion, contraception, and LGBTQ rights. He recently limited the ability of Texas minors to obtain birth control and authorized anti-LGBTQ discrimination in employment, health care, and education, in defiance of Supreme Court precedent. Before that, he seized control of border policy from Joe Biden, ordering U.S. diplomats to beg Mexican officials to hold Central American migrants on their side of the border. He is a shameless partisan, so it’s predictable he would support what amounts to a conspiracy theory about mifepristone’s approval in 2000. In a sense, Kacsmaryk is taking his cues from the Supreme Court itself, which recently ignored the facts of a case to rationalize an assault on the separation of church and state.
As my colleague Susan Matthews wrote, this case is fundamentally about who has power in America today. But it is also about a court’s power to transform fiction into truth. If Kacsmaryk rewrites the history of mifepristone’s approval as grounds to pull it from the market, his decision should command no respect or acquiescence from anyone—not the FDA, not abortion providers, and certainly not the public at large.