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Abortion Pill to Remain on the Market after Appeals Court Partially Overturns Lower Court Ruling
Less than a week after a federal judge in Texas suspended the Food and Drug Administration’s approval of the abortion pill mifepristone, an appeals court has preserved access to the drug.
In a 42-page ruling released late Wednesday, the 5th U.S. Circuit Court of Appeals allowed the FDA’s 2000 approval of mifepristone to remain in effect. The appeals court panel found that “it appears the statute of limitations bars” the plaintiffs’ challenge to the drug’s approval.
The court also recognized the government’s argument that reversing the FDA’s approval of mifepristone after more than 20 years would have “significant public consequences.”
However, the panel voted 2-1 to put on hold changes the FDA made in 2016 and 2021 that have made the drug easier to obtain and that have limited reporting requirements around non-fatal adverse events resulting from chemical abortion.
The panel’s ruling is expected to hold until the full case is heard on its merits. It is expected to eventually go to the Supreme Court.
The case stems from a lawsuit filed in November by Alliance Defending Freedom, or ADF, on behalf of the Alliance for Hippocratic Medicine, an organization of pro-life medical groups, as well as four pro-life doctors. The lawsuit claims that the FDA never had the authority to approve the two-pill chemical-abortion regimen when it did so nearly a quarter century ago.
Developed in France in the 1980s, the chemical-abortion process involves two pills: mifepristone, a progesterone blocker that kills the unborn baby by depriving it of nutrients, and misoprostol, which causes uterine contractions to empty the uterus.
To approve mifepristone under what is called “Subpart H” regulations – accelerated approval, which allows for post-approval safety measures – the FDA concluded that pregnancy is a “life-threatening illness.” ADF argues that the FDA had no business approving the two-drug regime under Subpart H because pregnancy is not an illness but is a “normal physiological state that many females experience one or more times during their childbearing years.”
The lawsuit also claims the FDA failed to properly study the safety of the regimen, and for almost two decades it stonewalled the doctors who were attempting to challenge the approval of the regimen, according to the lawsuit. Rather than increase scrutiny of the pills, the FDA has eliminated safeguards that did exist and has made the drug easier to obtain, according to ADF, a pro-life organization.
More than half of all abortions in the U.S. are now done using chemical-abortion pills. ADF’s lawsuit is focused on the FDA’s approval of mifepristone.
The initial case was heard by U.S. District Judge Matthew Kacsmaryk in Amarillo, Texas. Kacsmaryk, a Trump-appointed justice, overturned the FDA’s 2000 approval of the drug on Friday, writing that the agency “acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions.”
He stayed his opinion for seven days to allow the Biden administration time to appeal; shortly after the opinion came out, a Washington State federal judge issued a contradictory ruling.
“The FDA illegally approved dangerous chemical abortion drugs and has evaded its legal responsibility to answer the American people’s questions for two decades,” ADF senior attorney Erik Baptist said in a prepared statement on Wednesday, before the appeals court panel released its ruling. “The FDA put politics ahead of the health of women and girls when it failed to study how dangerous this drug regimen is and when it removed every meaningful safeguard that it previously implemented. The FDA should have to answer for damage it has done to the rule of law and the harm it has caused to countless women and girls.”
In a follow-up statement on Thursday, Baptist said that the appeals court’s decision to stop what ADF deems an “illegal mail-order abortion regime” is a “significant victory for the doctors we represent, women’s health, and every American who deserves an accountable federal government acting within the bounds of the law.”
Notably, the appeals court panel agreed that the individual doctors and their associations do appear to have standing to challenge the FDA’s actions, because they have provided, and almost certainly will continue to provide emergency care to women who take the pills and have adverse effects, the court found. The court noted that one of the adverse effects of mifepristone “is the ‘enormous stress and pressure’ physicians face in treating these women.”
“The doctors also face an injury from the irreconcilable choice between performing their jobs and abiding by the consciences,” the court wrote. “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 panel disagreed with the government’s contention that mifepristone is comparable to ibuprofen, noting that when the FDA first approved mifepristone, it imposed a “Black Box” warning that the drug “may lead to death or serious injury.”
The panel found that the timeliness of the plaintiffs’ challenge was a “close question,” but ultimately concluded that the six-year statute of limitations had expired regarding the FDA’s 2000 approval of mifepristone before the lawsuit was officially filed.
While some of the doctors involved initially challenged the FDA’s approval of mifepristone in 2002, and the FDA didn’t officially reject their challenge until March 2016, the ADF plaintiffs didn’t file their lawsuit until November 2022, more than six months beyond the statute of limitations, the court ruling says.
However, changes the FDA made in 2016 and 2021 to the delivery and reporting requirements regarding mifepristone were still timely, the panel ruled.
In 2016, the FDA increased the gestational age for which the drug could be used from seven weeks to ten, reduced the number of office visits required to get the drug from three to one, allowed non-doctors to prescribe abortion pills, and eliminated the requirement for prescribers to report non-fatal adverse events involving the pills. In 2021, during the Covid-19 pandemic, the FDA allowed the pills to be delivered through the mail.
Those changes are now on hold.
Kacsmaryk held an initial hearing on March 15, where the plaintiffs asked for a preliminary injunction requiring the FDA to temporarily withdraw or suspend its approval of mifepristone while the legal case continues. Kacsmaryk tried to keep the hearing quiet to avoid disruptions, but news of the hearing leaked. Kacsmaryk indicated that the court staff has faced security issues, including death threats, in connection with the case.
Supporters of legal abortion have accused of ADF of intentionally filing the lawsuit in Amarillo, Texas, knowing they would almost certainly draw Kacsmaryk, the only judge in the federal district.
The Washington Post has described Kacsmaryk as a “religious conservative who is widely regarded as a thorough and analytical legal thinker, but who also comes to his work with a long history of activism rooted in his religious beliefs.” Before he became a federal judge, Kacsmaryk was a federal prosecutor and then a lawyer for the conservative First Liberty Institute.