SouthernWorldwide.com – Justice Samuel Alito has issued a temporary stay, reinstating a Food and Drug Administration (FDA) rule that permits the abortion pill mifepristone to be sent through the mail. This administrative stay will remain in effect until May 11, providing the Supreme Court with additional time to review the emergency appeals filed by Danco Laboratories and GenBioPro, the manufacturers of mifepristone and its generic version, respectively.
The drug companies are urging the Supreme Court to not only set aside the appellate court’s order but also to hear and decide the case on its legal merits. Justice Alito has set a deadline of Thursday for Louisiana officials to submit their response to these emergency appeals.
This marks the second instance that the availability of mifepristone has come before the Supreme Court. Following the overturning of Roe v. Wade in 2022, groups advocating against abortion rights have been actively seeking to limit access to the widely used abortion pill. Their primary argument centers on the claim that the FDA did not sufficiently evaluate the safety and efficacy of mifepristone when it was initially approved in 2000, nor during the subsequent relaxations of its usage rules over the past decade.
In a previous decision in 2024, the Supreme Court unanimously dismissed a challenge brought forth by a coalition of anti-abortion medical professionals and organizations. The challenge had targeted the availability of mifepristone, but the court ruled that the plaintiffs lacked the legal standing to sue the FDA.
The case that was dismissed in 2024 pertained to a series of regulatory changes implemented by the FDA since 2016. These changes were designed to make the abortion pill more accessible. Notably, they included extending the gestational period for its use, broadening the range of healthcare professionals authorized to prescribe it, and eliminating the requirement for an in-person dispensing, thereby enabling the drug to be mailed directly to patients.
Read more: It Ends With Us" Lawsuit Settled by Blake Lively and Justin Baldoni
Previously, patients were required to obtain the medication in person from a healthcare provider. However, during the COVID-19 pandemic, the FDA suspended the enforcement of the in-person dispensing mandate. The agency subsequently concluded that the drug “may be safely used without in-person dispensing.” This led to the formal allowance in 2023 for mifepristone to be prescribed via telehealth appointments and dispensed through mail services.
Following the Supreme Court’s decision to uphold access to mifepristone, the state of Louisiana initiated a lawsuit challenging the FDA’s decision to permit mail delivery of the drug. However, a federal district court in Louisiana placed the litigation on hold in April, thereby preserving the eased conditions for mifepristone’s use while the FDA conducted its safety review.
Louisiana officials then appealed to the U.S. Court of Appeals for the 5th Circuit. On Friday, the 5th Circuit agreed to temporarily block the 2023 rule that allowed healthcare providers to remotely prescribe mifepristone and mail it to patients.
The unanimous panel of the 5th Circuit determined that Louisiana possessed legal standing to pursue the lawsuit. This was based on the argument that the state’s Medicaid program had incurred costs for emergency room care for two women who experienced complications after obtaining the abortion pill from an out-of-state provider.
The judges stated that the 2023 regulation “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.”
The 5th Circuit panel’s ruling asserted that “Every abortion facilitated by FDA’s action cancels Louisiana’s ban on medical abortions and undermines its policy that ‘every unborn child is [a] human being from the moment of conception and is, therefore, a legal person.'”
Louisiana has banned abortion, with limited exceptions, since the reversal of Roe v. Wade. In 2024, the state also passed legislation classifying mifepristone and misoprostol—the two drugs commonly used in medication abortions—as controlled substances, making possession without a prescription a criminal offense.
Danco and GenBioPro sought emergency relief from the Supreme Court immediately after the 5th Circuit’s decision, with Danco highlighting that the ruling “injects immediate confusion and upheaval into highly time-sensitive decisions.”
In their request, the drug company argued that the Fifth Circuit’s “unprecedented order forces patients, providers, and pharmacies into immediate uncertainty, with no transition period and no practical guidance.” They further elaborated that “Patients who have appointments — as soon as this morning — are in limbo. Providers who have already screened, counseled, and prepared patients for care may have to stop midstream, potentially unable to complete treatment plans that were set in motion days earlier.”
GenBioPro, in its own emergency appeal, stated that the 5th Circuit’s decision has “unleashed regulatory chaos” and risks abruptly halting access to mifepristone for patients nationwide, including in states where abortion remains legal.
The company emphasized that “Patients and clinicians have, for years, relied on dispensing mifepristone without an in-clinic visit, particularly for women from rural areas and those for whom transportation, childcare, or occupational constraints make it difficult to see providers in person.” They warned that “As a direct result of the Fifth Circuit’s order, patients nationwide may face delay or denial of access to time-sensitive medical care, supply-chain disruptions, and attendant health risks.”
White House spokesperson Allison Schuster issued a statement on Monday indicating that “The Trump administration remains committed to the President’s pro-life, pro-family, and pro-safety agenda and are closely following the active litigation on this issue. In the meantime, the FDA continues to work on a rigorous, Gold Standard Science review to get to the bottom of widespread concerns about mifepristone.”
