The decision, which applies to both states like Louisiana that ban abortion and states that allow the procedure, restores the FDA’s prior policy mandating that patients only obtain the drug in person from a physician. It is arguably the biggest rollback in access to abortion since the Supreme Court’s 2022 ruling overturning Roe v. Wade.
In their ruling, the judges rejected the Trump administration’s assertion that the state lacks standing, and that the court should hit pause on the case while the FDA conducts its own review of the drug. The court also rebuffed arguments by the two pharmaceutical companies that make mifepristone, Danco and GenBioPro, who argued that the court should defer to the FDA’s scientific judgment when it comes to whether and how patients can access the pills.
“We are alarmed by this court’s decision to ignore the FDA’s rigorous science and decades of safe use of mifepristone in a case pursued by extremist abortion opponents,” GenBioPro CEO Evan Masingill said in a statement. “We remain committed to taking any actions necessary to make mifepristone available and accessible to as many people as possible.”
A Louisiana district court ruled in April to grant the Trump administration’s request to put its lawsuit against the FDA on ice, but demanded the agency quickly complete its review of the pill’s safety and give the court a status report by this coming October.
That judge, Trump appointee David C. Joseph, warned that granting Louisiana’s request to reimpose the rule that patients only obtain mifepristone in person from a doctor would be, in effect, “government by lawsuit.”
Louisiana quickly appealed that ruling, arguing that its residents needed immediate “relief” from the influx of abortion pills prescribed online by doctors in other states.
This case is one of several filed by GOP state attorneys general seeking to cut off access to pills that are being mailed to patients in their states in defiance of bans on abortion. Idaho, Kansas, and Missouri are making arguments similar to Louisiana’s in the hopes of a telehealth ban, while Florida and Texas are trying to go further and outlaw the sale of mifepristone altogether, challenging the 25-year-old FDA approval of the drug.
In all the lawsuits, the Trump administration has declined to defend the FDA’s rules for the drugs on the merits, and has instead argued the states lack standing or are acting prematurely, and has requested courts allow the agency to conduct its review without interference.
That stance has exacerbated the anti-abortion movement’s frustration with the administration over its inaction to curb the availability of pills. Some GOP lawmakers, who say they don’t believe FDA is reviewing mifepristone in good faith, have introduced bills to force the agency’s hand, but they are not likely to pass in the currently gridlocked Congress.
Anti-abortion activists celebrated Friday’s ruling as a “crippling” blow to the “abortion industry” and a reversal of “injudicious FDA deregulation under the Biden Administration.”
“The era of mail-order abortion is near its end,” said Gavin Oxley, a spokesperson for Americans United for Life.
Medical and progressive advocacy groups predicted the case will be swiftly appealed to the Supreme Court, which could pause the ruling and restore telemedicine access to the drugs while the case plays out in lower courts.
“I expect briefs to be filed likely next week,” said Molly Meegan, the chief legal officer for the American College of Obstetricians and Gynecologists, which is supporting the drugmakers in the case in defending access to the pills. “And, in all likelihood, a ruling just on the stay within the next couple weeks.”
But even a temporary disruption of access to the drugs will have massive implications. Abortion pills are used in nearly two-thirds of all pregnancy terminations, and a quarter of patients depend on telehealth to obtain them. The ruling also cuts off telemedicine prescription of the drug for non-abortion purposes, such as easing miscarriages. Peer-reviewed studies have found that mifepristone is equally safe whether obtained in person from a doctor or online.