Where Do We Stand With Mifepristone in the United States?

Making Sense of the Madness

Valerie French MD, MAS: Valerie French MD, MAS

This past April was a whirlwind for the medical community caring for patients accessing medication abortion. Starting in November 2022, and then what felt like every few days in early April 2023, the status of mifepristone has been in the courts. With each ruling, a flurry of activity (and confusion) followed for clinics, hospitals, health care professionals, and patients about what care is available and for how long. Discussions of stockpiling mifepristone, pivoting to misoprostol-only medication abortion regimens, and many questions about “What next?” swept the country and social media. What happened? How did we get here? And where does mifepristone access stand in the United States today?

Mifepristone, a progesterone-receptor modulator that sensitizes the uterus to the contraction-inducing activity of prostaglandins, was initially approved by the U.S. Food and Drug Administration (FDA) in 2000, with updates to the label in 2016 and 2019.¹ Since then, mifepristone has been used safely for patients undergoing abortion up to 70 days of gestation as part of the following evidence-based regimen: 200 mg oral mifepristone followed by 800 micrograms of the prostaglandin misoprostol taking buccally, sublingually, or vaginally 24–48 hours later.² Further research supports the safety of mifepristone for use in medication abortion through 84 days.³ In fact, using mifepristone as part of medication abortion is one of the most scientifically rigorously studied areas of medicine, with dozens of studies supporting its safety and efficacy.^2,4 Of the 930,160 abortions in the United States in 2020, 53% were medication abortions.⁵

Since its original FDA approval, off-label use of mifepristone has increased the efficacy of medically managed early pregnancy loss. A 2018 randomized controlled trial demonstrates that treatment with mifepristone before misoprostol compared with misoprostol alone decreases the risk that a patient will need uterine aspiration from 1 in 5 to 1 in 10.⁶ Subsequently, pretreatment with mifepristone has become the standard of care for patients treated with medications for early pregnancy loss.⁷ With the annual rate of spontaneous and induced abortion managed medically, hundreds of thousands of patients need mifepristone every year in the United States.^5,8,9

Despite the preponderance of evidence supporting mifepristone's safety and efficacy, several antiabortion groups sued the FDA in November of 2022, requesting the courts order the FDA to withdraw its approval and thus remove mifepristone from the market. On April 7, 2023, Matthew Kacsmaryk, a federal judge in Texas, issued a preliminary ruling invalidating the FDA approval of mifepristone. A federal appeals court panel allowed mifepristone to remain on the market while the case is being reviewed, but that same panel ordered a reversal of all FDA regulatory changes that have occurred since 2016 (including approval of a generic version of mifepristone and steps that increase the availability and distribution of the drug). On the same day of Judge Kacsmaryk's ruling, Thomas Rice, a federal judge in Washington state, issued an order for the FDA to maintain the availability of mifepristone in some states. Judge Rice's order came as a follow-up to a case from February of 2023 in which the state of Washington sued the FDA to remove restrictions on mifepristone prescriptions. This left the FDA under two conflicting orders: a court ruling from Judge Kacsmaryk to withdraw mifepristone's approval and a court ruling from Judge Rice to maintain it. Several rulings and stays ensued, and, on April 21, 2023, the Supreme Court stepped in, blocking the Texas ruling and sending it back to the Fifth Circuit Court of Appeals for a hearing. That hearing occurred on May 17, 2023. We don't yet know when a decision will be announced. For now, mifepristone remains legal and available for medication abortion where abortion is permitted by state law.¹⁰

As physicians, what do we make of all of this? We have abundant, robust science supporting the safety and efficacy of mifepristone, yet the stigma around abortion has led others to question its use. I am deeply distraught that the politics around abortion threaten a pillar of medication safety in the United States—the FDA, which approved mifepristone 23 years ago. Are we now to ignore solid science and the backing of the FDA and instead follow the opinions of judges? For this author, the answer is unequivocally no—never. I trust the science behind mifepristone and reject political interference in medical care. We, the medical community—not judges, not interest groups, not legislators—determine how safe, evidence-based care is delivered to the patients we serve.