Background

Medication is currently the method used in almost two-thirds of abortions in the United States and is usually delivered through a two-drug regimen within the first 12 weeks of pregnancy. The first of those medications is mifepristone, which was first approved by FDA in 2000.

During the COVID-19 pandemic in 2021, FDA lifted its requirement that patients must visit a medical provider in person to obtain mifepristone. That decision was made permanent in 2023 and spurred the creation of multiple telemedicine abortion services.

Following the Supreme Court's overturning of Roe v. Wade in 2022, many conservative states implemented abortion bans, which led several other states to pass shield laws protecting the ability of abortion providers to prescribe pills via telemedicine and ship them to patients in states with abortion bans.

In April 2023, Judge Matthew Kacsmaryk ruled against FDA's approval of mifepristone, arguing that the agency didn't adequately review scientific evidence or follow the proper protocols when it approved the drug in 2000.

In response to Kacsmaryk's ruling, more than 200 pharmaceutical companies signed a statement calling for the reversal of the decision. In June 2024, the Supreme Court unanimously rejected the challenge to mifepristone, arguing the plaintiffs lacked legal standing to challenge FDA's decision.

Appeals court halts mifepristone access via telemedicine

In this case, the state of Louisiana sued FDA, arguing that the agency's decision to remove the in-person dispensing requirement for mifepristone was based on inadequate or flawed data and that making abortion pills available by mail has allowed patients to access the medication despite the state's near-total abortion ban.

A panel of the U.S. Court of Appeals for the Fifth Circuit ruled 3-0 in favor of Louisiana, saying that the state "has shown that it is irreparably harmed without a stay."

"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,'" the ruling said.

Anti-abortion groups hailed the ruling, with Tony Perkins, president of the Family Research Council, saying in a post on X that the stay was granted "because Louisiana has a good chance of winning its case against the FDA. This should be before the U.S. Supreme Court soon."

The National Right to Life Committee said the ruling "restores a critical layer of oversight" in women's health. "Women deserve better than an abortion-by-mail system that prioritizes ideology over safety," said Carol Tobias, the group's president.

Abortion rights supporters said the ruling was alarming and could have wide-ranging effects even in states where abortion is legal.

SCOTUS temporarily restores mifepristone access

In response to the appeals court ruling, two mifepristone manufacturers filed an emergency appeal to the Supreme Court.

Danco Laboratories initially asked the appeals court to put a one-week hold on its ruling, which the drugmaker said "renders inoperable an agency action that has already been in effect for years."

After the court didn't respond to Danco's request, the company turned to the Supreme Court, filing an emergency appeal.

"It bears emphasis how unprecedented the Fifth Circuit's order is," Danco said in its application to the Supreme Court. "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."

GenBioPro, later filed its own appeal, saying the Supreme Court should "preserve the long-settled status quo" and avoid a "grave disruption" to the most common method of abortion.

"The order is deeply unsettling to drug sponsors, healthcare providers, patients, and the public — all of whom rely on FDA's exercise of scientific judgment and orderly administration of the Nation’s complex system of drug regulation," GenBioPro wrote in its filing.

On Monday, the Supreme Court temporarily restored access to mifepristone via telemedicine, allowing women to obtain the pill without an in-person visit to a doctor.

In two brief orders, Justice Samuel Alito said the appeals court's decision would remain on hold until at least May 11, giving the Supreme Court time to consider next steps in the case as it weighs the emergency requests from Danco and GenBioPro.