WASHINGTON (CN) — The Supreme Court agreed Wednesday to decide if the use of a popular abortion pill should be limited nationwide. The move marks a major milestone in the post-Roe abortion landscape.
A group of conservative Christian doctors claims the drug mifepristone is unsafe and that the Food and Drug Administration rushed its approval two decades ago. In its suit, Alliance for Hippocratic Medicine claims the government erred two decades ago in approving mifepristone, and the last five presidential administrations were wrong to provide subsequent approvals affirming its safety.
Despite its safety record, a federal judge — and then an appeals court — paused mifepristone’s approval, restricting the medication’s use nationwide. The Supreme Court stepped in to pause those restrictions in April while considering the case.
The government said putting restrictions on mifepristone would have dire consequences.
“If the portions of that order affirmed by the Fifth Circuit are now allowed to take effect, it would upend the regulatory regime for mifepristone, with damaging consequences for women seeking lawful abortions and a healthcare system that relies on the availability of the drug under the current conditions of use,” U.S. Solicitor General Elizabeth Prelogar wrote in the government’s petition.
Although the case centers on abortion access, the government worries that a precedent allowing a two-decade-old approval to be upended could spread across the drug regulatory space.
“And the logic of the Fifth Circuit’s unprecedented decision would threaten to severely disrupt the pharmaceutical industry and prevent FDA from fulfilling its statutory responsibilities according to its scientific judgment,” Prelogar wrote.
Mifepristone was approved by the FDA under the brand name Mifeprex in 2000 after a four-year review by the agency. It's part of a two-drug regimen, in concert with misoprostol, used to end early pregnancy. Patients who take the drug often experience symptoms similar to those of a miscarriage, including cramping and bleeding.
Doctors specializing in reproductive health have consistently found mifepristone to be safe and effective, with adverse reactions occurring in less than a fraction of 1% of cases. Other common medications are considered to be more high-risk, such as Viagra, which has a mortality rate of more than six times greater than mifepristone, and penicillin, which has a mortality rate of three times greater.
Mifepristone’s mortality rate stands at 0.65 per 100,000 people. In comparison, the maternal mortality rate in the U.S. is 32.9 per 100,000 live births. This rate has increased in recent years.
In 2016, the FDA altered mifepristone’s prescription and distribution requirements. After 20 years of use in practice and in clinical trials, the FDA increased the gestational age limit for the drug’s prescription from seven to ten weeks. The agency also reduced the number of in-person clinic visits from three to one and allowed certain licensed non-physician healthcare providers to prescribe the medication. These approvals also altered mifepristone’s dosing regime.
The FDA approved mifepristone’s generic form created by GenBioPro in 2019. The Covid-19 pandemic led the FDA to throw out the in-person dispensing requirement; the agency subsequently found this requirement was not needed in the future.
The Alliance for Defending Freedom filed a lawsuit challenging mifepristone’s approvals in November 2022, only four months after the justices ruled in Dobbs v. Jackson Woman’s Health Organization. The Tennessee-based group was incorporated in Amarillo, Texas, a month prior to filing its lawsuit, virtually guaranteeing it would be heard by U.S. District Judge Matthew Kacsmaryk, a Donald Trump appointee.
Although they have never actually administered mifepristone, the conservative doctors claim they have been harmed by the drug’s rare adverse reactions. The doctors argue there's a chance one of these rare cases could show up in a hospital they work in, and they would be forced to treat the patient.
“These doctors have suffered concrete and specific injuries, including forced participation in elective abortion, because of FDA’s deregulation of chemical abortion, Erin Hawley, an attorney with the Alliance Defending Freedom representing the doctors, wrote. “That emergency room physicians — like the respondent doctors — will often be called upon to treat chemical abortion complications is not a bug in the system but part of its very design.”
The lawsuit challenged the FDA’s 2000 approval of Mifeprex, the 2016 updates to how the drug can be used, the 2019 approval of generic mifepristone, the 2021 exercise of enforcement discretion, and two denials of citizen petitions.
Kacsmaryk granted the doctors’ motion for an injunction blocking mifepristone’s approval. The Supreme Court’s interference in the case came after the Fifth Circuit refused to block Kacsmaryk’s entire injunction.
The Fifth Circuit rejected arguments against the drug’s 2000 approval but affirmed the suspension of the 2016 and 2021 approvals. In practice, this would require more in-person visits to obtain mifepristone, limit its use to only seven weeks gestational age, and alter its dosing. The government says it would have to remove mifepristone from shelves nationwide to comply with the ruling.
“The Fifth Circuit’s decision warrants this court’s review because it would impose an unprecedented and profoundly disruptive result: Neither respondents nor the courts below identified any prior decision abrogating FDA’s approval of a drug or limiting a drug’s availability based on a disagreement with the agency’s judgment about safety or effectiveness — much less doing so at the behest of plaintiffs with such an attenuated claim of standing and imminent harm,” Prelogar wrote.
Per the court's custom, the justices did not provide an explanation for granting the petition.
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