A federal appeals court partially stayed a lower court’s ruling that suspended approval of the abortion drug mifepristone, but cut off prescriptions delivered through the mail.
The Fifth Circuit Court of Appeals partially granted a request for a stay from the federal government early Thursday morning to a lower court’s ruling that sought to strip approval of the drug originally cleared back in 2000. However, the court only partially granted the Department of Health and Human Services’ request for a stay and found that the anti-abortion group which brought the original lawsuit had standing to do so.
The court ruled that it was “unsure” that the Food and Drug Administration had reopened the 2000 approval of the drug when it made a change to its risk evaluation and management strategy, which is a drug safety program used by the agency for certain products with a serious side effect, and denial of a citizen petition in 2021, the filing said.
But the ruling did say that a key requirement of the risk evaluation and mitigation strategies (REMS), that the drug only be dispensed in person, was removed by the FDA back in 2016. This change enabled the drug to be delivered through the mail and according to the judges a “stark departure from previous regulatory approaches.”
It also found that the drug must be dispensed in the time period it was approved for. Under the REMS, the drug could only be taken under 50 days of gestation, but that increased to 70 days in 2016.
In addition, the court ruled that the anti-abortion doctor group Alliance for Hippocratic Medicine does have standing to bring the lawsuit as they must care for patients who have complications from the drug.
The court found that since the FDA had failed to regulate the drug then the doctors “have had to devote significant time and resources to caring for women experiencing mifepristone’s harmful effects,” the ruling said. “This harm is sufficiently concrete.”
Doctors also have an “irreconcilable choice between performing their jobs and abiding by their consciences,” the court added. “These doctors structured their careers so they would not have to administer abortions. And yet, because women often come to hospitals when they experience complications from these drugs, these doctors sometimes have no other choice but to perform surgical abortions.”
The Department of Justice disagreed with the ruling and will ask the Supreme Court for emergency relief, said Attorney General Merrick Garland in a statement.
The lower court judge had stayed his ruling for a week to give HHS time to issue an appeal.
The American Medical Association sounded the alarm that the Fifth Circuit Court of Appeals' ruling "undermines evidence-based decisions by the FDA" and called the decision a "profoundly dangerous step backwards on access to mifepristone."
"The appeals court elevated speculative pseudoscience over data and evidence, arbitrarily rolling back access to a safe and effective drug and leaving millions of women without a critical medication for reproductive health care. The AMA fully supports the Department of Justice’s request for emergency relief from the U.S. Supreme Court and will continue fighting to prioritize evidence-based decisions that maintain access to mifepristone," AMA president Jack Resneck Jr., M.D. said in a statement.
The ruling, which stays parts of the lower court ruling through the appeals process, is likely to further complicate the landscape for access to the abortion drug, which has surged in use especially via mail after the Supreme Court struck down Roe V. Wade last year.
A federal judge in Washington ruled that mifepristone’s approval must remain in place for more than a dozen blue states who filed a lawsuit to keep it.