Amid the legal battles surrounding access to the abortion pill mifepristone, a federal appeals court seems to be leaning toward restricting access to the drug after hearing arguments on Wednesday, multiple news outlets reported.
Mifepristone has been widely available for 23 years following its approval by the Food and Drug Administration in 2000. In November 2022, anti-abortion plaintiffs contended in a lawsuit that the FDA had acted outside of its authority when it approved of mifepristone and then expanded access to the drug by allowing it to be dispensed via mail.
Last month, U.S. District Judge Matthew Kacsmaryk in Texas ruled that the FDA’s approval of mifepristone was unlawful and that the drug should be withdrawn from the market.
But the Supreme Court blocked the lower court’s decision from going into effect a few weeks later through an emergency stay, which also allowed mifepristone to remain available. The 5th U.S. Circuit Court of Appeals is now reconsidering the Texas judge’s ruling to restrict mifepristone access.
A three-judge panel of the 5th Circuit pressed lawyers representing the government and manufacturers of the abortion drug, as well as the anti-abortion plaintiffs. The judges were appointed by Republican presidents and have previously supported abortion restrictions.
The plaintiffs wrote in court filings that the FDA had ignored safety risks when it approved mifepristone and then removed safeguards to increase access to the drug, including by reducing the number of doctor’s appointments needed to receive a prescription and by allowing mifepristone to be mailed to patients.
“These actions do not reflect ‘scientific’ judgment but politically driven decisions to unlawfully push a dangerous regimen,” said lawyers for the Alliance Defending Freedom, a Christian conservative group behind the lawsuit, according to The Texas Tribune.
But the federal government argued that the court shouldn’t second-guess the FDA’s expertise, which led to the 23-year approval of the drug — a stance that one of the judges rejected on Wednesday, The Washington Post reported.
“I don’t understand this idea that FDA can do no wrong,” Judge James C. Ho said, according to The Post. “We are allowed to look at FDA just like any other agency.”
Lawyers for the federal government and Danco Laboratories, the company that manufactures the name-brand version of mifepristone, argued that the lawsuit has no standing given how long it’s been since the FDA’s approval of the drug. There is a six-year statute of limitations that applies when challenging federal agency actions.
But Ho seemed to be sympathetic to the plaintiffs’ argument that that six-year time frame restarted in 2021 when the FDA expanded access to the drug by allowing it to be sent directly to people by mail.
“You think the mail issue is not a dramatic change? You don’t think going from seven to ten weeks is a dramatic change? You don’t think going from three visits to just one without a doctor?” Ho asked while questioning Danco’s lawyer, NPR reported. “We can’t deny this is a big-stakes issue.”
The lawsuit has gained national attention over the past few months and arrives as states ban and restrict abortion nationwide following the Supreme Court’s decision overturning Roe v. Wade last year.
The American Civil Liberties Union released a statement saying the case to restrict mifepristone has “no legal or scientific merit.”
“As the arguments today made clear, the whole point of the case is to prevent anyone in America, no matter where they live, from using a medication that has been safely used in this country for decades and is used in most abortions today,” Jennifer Dalven, director of the ACLU Reproductive Freedom Project, said in an emailed statement.
Dalven continued: “We knew that those who want to stop women from making their own decisions about pregnancy, wouldn’t stop with the reversal of Roe v. Wade and this case is the next step in their plan to ban abortion nationwide.”
The 5th Circuit has yet to make its decision, which is then expected to go back to the Supreme Court. But regardless of the appeals court’s decision, mifepristone will remain available until the Supreme Court resolves the case, either by ruling again or refusing to hear the appeal.