(CP) A federal appeals court will not allow a lower court's suspension of the U.S. Food and Drug Administration's decades-old approval of the abortion pill to take effect but will allow the court's temporary block on the distribution of the pill by mail and other restrictions.
On Wednesday, a three-judge panel on the 5th U.S. Circuit Court of Appeals partially granted the request of the Biden administration to stay a decision by a federal judge in Texas last week that suspended the FDA's 2000 approval of mifepristone.
Mifepristone is the first drug in the chemical abortion regimen, which destroys the environment in the uterus and starves an unborn baby to death. Also known as chemical abortion or the abortion pill, mifepristone has emerged as a source of safety concerns for the pro-life movement.
The Alliance for Hippocratic Medicine, the American Association of Pro-Life Obstetricians & Gynecologists, the Christian Medical & Dental Associations and four individual doctors asked a federal judge to suspend the FDA's approval of mifepristone as well as subsequent modifications to rules governing the use of the abortion pill, which included a provision allowing it to be distributed in the mail.
Judge Matthew Kacsmaryk, appointed to the bench by former President Donald Trump, granted the plaintiffs' request in a decision published Friday. The ruling was not set to take effect for a week to give the defendants time to appeal. Kacsmaryk's decision was reviewed by a panel of appellate judges, including George W. Bush-appointed Catharina Hayes, Trump-appointed Kurt Engelhardt and Trump-appointed Andrew Oldham.
The appellate court overruled the district court's suspension of the FDA's 2000 approval of mifepristone, citing a six-year statute of limitations.
However, it upheld parts of the ruling striking down the relaxation of the requirements for distributing mifepristone that began in 2016. Most recently, the FDA abandoned the requirement that those seeking to obtain the abortion pill must have an in-person visit with a doctor. The relaxed requirements enabled women wishing to take the abortion pill to receive it through the mail.
The changes also allowed the pills to be prescribed to women at up to 10 weeks gestation instead of up to seven weeks.
The appellate court ruled that the FDA "failed to 'examine the relevant data' when it made the 2016 major [Risk Evaluation and Mitigation Strategies] changes."
"That's because FDA eliminated REMS safeguards based on studies that included those very safeguards," the opinion states. "Imagine that an agency compiles studies about how cars perform when they have passive restraint systems, like automatic seatbelts. For nearly a decade, the agency collects those studies and continues studying how cars perform with passive safety measures. Then one day the agency changes its mind and eliminates passive safety measures based only on existing data of how cars perform with passive safety measures."
Concerns about the abortion pill primarily focus on the safety risks the drug poses to women. Wednesday's ruling includes a picture of a "Black Box" warning on mifepristone that informs users that it can cause "serious and sometimes fatal infections or bleeding," including the possibility of "prolonged heavy bleeding." Additional potential side effects listed on the "Black Box" warning include "sustained fever, severe abdominal pain" as well as "abdominal pain or discomfort, or general malaise (including weakness, nausea, vomiting or diarrhea)."
The U.S. Department of Justice has indicated its intention to appeal Wednesday's decision to the U.S. Supreme Court.
"The Justice Department strongly disagrees with the Fifth Circuit's decision in Alliance for Hippocratic Medicine v. FDA to deny in part our request for a stay pending appeal," Attorney General Merrick Garland said in a statement. "We will be seeking emergency relief from the Supreme Court to defend the FDA's scientific judgment and protect Americans' access to safe and effective reproductive care."
In a statement, the national pro-life grassroots advocacy organization Susan B. Anthony Pro-Life America reacted favorably to the 5th Circuit's ruling.
"We are very encouraged by this landmark win for women and girls. The Court recognized that the abortion pill is dangerous and rolled back Biden's reckless mail-order abortion scheme," said SBA Pro-Life America State Policy Director Katie Daniel.
"We still believe it never should have been approved in the first place and we look forward to the Supreme Court hearing this case." Daniel claims "the FDA ignored science and placed politics over the safety of women and girls, as well as the lives of countless unborn children," Daniel expressed gratitude that "finally they are beginning to be held accountable."
Mini Timmaraju, president of the pro-abortion advocacy group NARAL Pro-Choice America, said the organization is "relieved that the FDA's approval of mifepristone stands for now." However, she claimed the 5th Circuit's decision shows how "our court system has been rigged by the far-right to deliver results that are undemocratic and dangerous."
"But by reinstating outdated and unnecessary restrictions, these judges — many of whom were appointed by a twice-impeached now-indicted former president — put tens of millions of people's health at risk. Anti-choice extremists want to ban all abortion, everywhere. They can't win elections, so they've turned to the courts to do their dirty work. As this legal fight goes on, our reproductive freedom champions across the country must work to protect access to medication abortion no matter what happens next in the courts."
Planned Parenthood Federation of America CEO Alexis McGill Johnson also condemned the ruling.
"We are furious that yet another court would choose to jeopardize the health and futures of the millions of people who rely on mifepristone for abortion care," she stated. "This baseless case is a politically motivated attack to further restrict access to abortion that will place care out of reach for patients — and we will not stand for it."
McGill Johnson warned that "if allowed to stand, the consequences of this decision will be catastrophic not just for medication abortion access, but the entire drug approval system."
Jeanne Mancini, president of the March for Life, wrote in a Twitter thread that the 5th Circuit "reinstated important and commonsense health and safety protections surrounding the use of chemical abortion drugs," referring to the requirement that women see a doctor before taking the abortion pill.
"The FDA's elimination of these safeguards shows a reckless disregard for women's health when it comes to abortion," Mancini added. "This dangerous drug regimen has been shown to harm women, sometimes fatally, in addition to ending the lives of unborn children."
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