A federal appeals court in New Orleans on Wednesday heard arguments that could shape the future of abortion access in the U.S.
The case originated with anti-abortion advocacy groups and doctors challenging the Food and Drug Administration’s approval of mifepristone, which is widely used in medication abortions. The U.S. Supreme Court in April put a hold on a Texas district court ruling that would have blocked access to mifepristone and sent the case back to the Fifth Circuit Court of Appeals.
Oral arguments started Wednesday with the Department of Justice, representing the FDA, arguing that the plaintiffs do not have the legal right to bring any of their claims because they’re not at imminent risk of being injured by the FDA’s actions. “FDA’s approval of a drug doesn’t require anyone to do anything,” Justice Department lawyer Sarah Harrington told the three-judge panel. “The manufacturer doesn’t have to make it, nobody has to ship it, nobody has to prescribe it, and nobody has to take it.”
Erin Hawley, a lawyer for the plaintiffs, told the court that FDA’s approval and later modification of restrictions on mifepristone’s use led to safety issues that caused doctors to be “forced to participate in and complete elective abortions, contrary to their consciences.”
While the case proceeds, mifepristone remains available where state law permits abortion. If the lower court’s ruling is ultimately allowed to stand, however, it would cut off mifepristone access nationwide, cast doubt on the continued availability of many other FDA-approved treatments, and raise much broader questions about the FDA’s autonomy, patient advocates and industry groups say.
Mifepristone is part of a two-drug regimen used in 98% of medication abortions in the U.S. in 2020, according to Guttmacher Institute, a reproductive-rights nonprofit, and is also used in the medical management of miscarriages. Over half of all U.S. abortions are medication abortions, which are more accessible for many people than procedural methods. The U.S. Supreme Court’s 2022 decision overturning Roe v. Wade cleared the way for states to set their own abortion policies and intensified debate over medication abortion access.
Given mifepristone’s widespread use, a court decision making the drug unavailable would “cause massive shock to the provision of care as clinics scramble to try and adjust,” said Rabia Muqaddam, senior staff attorney at the Center for Reproductive Rights, a legal advocacy group. Such an outcome could be “as catastrophic as the Dobbs decision overturning Roe, if not more so,” she said, in part because it could unleash litigation challenging many other FDA-approved medications.
If mifepristone access were barred completely, “the implications are so terrifying, it’s very challenging to even talk about,” said Leila Abolfazli, director of national abortion strategy at the National Women’s Law Center, a gender justice advocacy group. “To yank away a key pillar of abortion care in this country that is reeling in the chaos of intersecting public-health and legal crises after the Supreme Court decision last summer — it is pure harm.”
All three judges who heard the case Wednesday were nominated by Republicans —two nominated by former President Donald Trump and one by former President George W. Bush.
The anti-abortion groups that filed the lawsuit claim that mifepristone is unsafe and that FDA acted outside its authority in initially approving the drug and later modifying the conditions for its use. The federal government said in a court filing that the FDA approved mifepristone after multiple clinical trials involving thousands of patients demonstrated its safety and that “study after study over the past two decades confirms the soundness of FDA’s decision.”
A decision from the three-judge panel could come in several weeks, legal experts say, and the losing party can appeal to the full Fifth Circuit or to the Supreme Court.
Much of the argument Wednesday centered on whether the anti-abortion groups have the legal standing to make their claims. The plaintiffs say they have standing in part because they allege that FDA’s actions have increased the number of complications related to medication abortions, forcing doctors who have ethical and medical objections to abortion to care for those patients in emergency situations. The federal government responded in court that the plaintiffs lack the standing to raise any of their challenges and that “the possibility that some women might at some point seek care from some plaintiff doctors for exceedingly rare adverse events is not a legally cognizable injury.”
Circuit court judge Jennifer Walker Elrod raised questions at the hearing Wednesday about telemedicine prescribing of mifepristone, asking if the whole process could take place over email. Harrington, the DOJ lawyer, told the court that the FDA does not dictate the practice of medicine and that such issues aren’t relevant to the FDA’s determination that mifepristone is safe and effective.
The lawsuit’s implications stretch far beyond the abortion pill, putting patients in general at risk of losing access to medically necessary treatments, patient advocates say. Patients “would no longer have the security of knowing that determinations about drug safety and effectiveness rest with FDA experts in science and medicine,” the Leukemia and Lymphoma Society and several other patient and provider groups wrote in a friend-of-the court brief filed early this month. The lower court’s “undue interference with FDA’s authority regarding drug safety and effectiveness presents a grave and, in some cases deadly, risk for patients,” the groups wrote.
FDA veterans emphasize that mifepristone went through the same rigorous approval process that the agency applies to all new drug applications. The agency’s 2000 approval of mifepristone came “after an intensive review spanning more than four years, at least 92 submissions by the drug sponsor, and a unanimous advisory committee vote in favor of approval,” several former FDA commissioners and acting commissioners wrote in a friend of the court brief. FDA performed an exhaustive review of large volumes of clinical trial data across three rounds of review, they said. The lower court’s analysis, they said, relied on studies or other information “that on their face were scientifically unsound.” The lower court “cited an unsubstantiated study based on review of anonymous blog posts” to support a finding that mifepristone negatively impacts patients’ mental health, the brief said.
Industry trade groups are raising alarms about the case’s potential impact on pharmaceutical innovation and investment. “The district court erred by replacing FDA’s scientific judgments with its own views on what information should be considered and how it should be assessed,” pharmaceutical industry trade group Pharmaceutical Research and Manufacturers of America, joined by several other industry trade groups, wrote in a friend-of-the-court brief filed with the Fifth Circuit. The lower court’s ruling “risks stifling pharmaceutical innovation by disrupting industry’s reasonable investment-backed expectations,” the brief said.
