Danco Laboratories, the manufacturer of the abortion pill mifepristone, has lodged an emergency appeal with the US Supreme Court asking it to block a lower court ruling that would require an in-person medical examination before the medication can be prescribed.
Emergency appeal to the Supreme Court
The company filed its request on Saturday 2 May, hours after the Fifth US Circuit Court of Appeals temporarily reinstated the in-person requirement, effectively preventing telemedicine providers from prescribing mifepristone by mail. The appeals court acted in response to a legal challenge brought by the state of Louisiana. In its filing, Danco argued that the circuit court’s decision “injects immediate confusion and upheaval into highly time-sensitive medical decisions”, forcing the manufacturer, healthcare providers, patients and pharmacies “all to guess at what is allowed and what is not”. The company warned the ruling would cause “chaos”.
The Fifth Circuit ruling
The three-judge panel of the Fifth Circuit said it agreed with Louisiana that the current, looser rules governing mifepristone “facilitates nearly 1,000 illegal abortions in Louisiana per month”. The state has argued that allowing the drug to be dispensed through the mail gives women a way to bypass abortion bans and ignores the risk of complications such as sepsis and haemorrhaging. The pill is currently used in nearly two-thirds of pregnancy terminations in the United States, including in states that have enacted abortion restrictions.
The ruling is the latest in a series of legal clashes over access to mifepristone, which was first approved by the US Food and Drug Administration (FDA) in 2000. The FDA initially imposed strict regulations, including mandatory in-person visits and physician-only prescribing, but has gradually relaxed those rules – removing the in-person dispensing requirement in 2021 and allowing certified retail pharmacies to dispense the drug in 2023. Telehealth has become a crucial route for abortion care, with an estimated one in four abortions nationally now prescribed via telemedicine. Advocates warn that the Fifth Circuit’s decision, which applies nationwide, will disproportionately affect rural communities, people with disabilities, those on low incomes, survivors of domestic violence and communities of colour.
The appeals court ruling is the result of a lawsuit brought by Louisiana, which contends that mail-order dispensing “injures Louisiana by undermining its laws protecting unborn human life and also by causing it to spend Medicaid funds on emergency care for women harmed by mifepristone”. Medical organisations and advocates maintain that mifepristone is safe and effective, citing decades of research, and argue that the restrictions are medically unnecessary and politically motivated.
Danco’s legal arguments
In its emergency appeal to the Supreme Court, Danco argued that Louisiana’s lawsuit “should have been dismissed outright”. The company said the case shares the same fundamental flaws as a previous challenge brought by anti-abortion doctors – a challenge the Supreme Court rejected in 2024 on the grounds that the plaintiffs lacked legal standing. Danco emphasised that “never before has a federal court purported to immediately enjoin a several years’ old drug approval; restrict a distribution system for that drug that manufacturers, providers, patients, and pharmacies have all been using for years; or reinstate conditions that FDA determined do not meet the mandatory statutory criteria”.
The company pointed to the disruption the circuit court’s ruling would cause to a distribution system that has operated for years. Danco said the decision forces all parties involved to guess at what is permitted and what is not, creating “immediate confusion and upheaval” in time-sensitive medical decisions. The company also noted that the FDA itself is currently reviewing the safety of mifepristone after a coalition of nearly two dozen Republican attorneys general requested a review last year. Earlier this year, the Trump administration petitioned a federal judge to pause Louisiana’s challenge until that review was complete. The circuit appeals court, however, blocked that pause and instead reinstated the in-person dispensing requirement while Louisiana appeals the judge’s initial decision.
The Fifth Circuit’s ruling has been described as the most significant threat to abortion access since the overturning of Roe v. Wade in 2022. Other legal challenges to mifepristone – brought by Missouri, Kansas and Idaho – remain pending. The Supreme Court’s decision on Danco’s emergency appeal will determine whether the in-person dispensing requirement is immediately paused or whether the Fifth Circuit’s ruling stands while the case proceeds.
