By Dave Andrusko
On December 13, 2023, the Supreme Court agreed to “weigh appeals from the Biden administration and drugmaker Danco defending several Food and Drug Administration decisions that made it easier to access and use the mifepristone pill,” according to Lawrence Hurley of NBC News. Much is at stake since the “abortion pill” accounts for over half of the abortions performed in the United States.
Last April, U.S. District Judge Matthew Kacsmaryk agreed with the challenge brought by the Alliance Defending Freedom and, among other things, invalidatedthe FDA’s original approval in 2000 of the drug. The Supreme Court put that decision on hold while litigation continued.
Subsequently, the 5th U.S. Court of Appeals narrowed the scope of Judge Kacsmaryk’s ruling. “The [Supreme] court will instead focus on later FDA actions from 2016 onward that made it easier to access the pill, including the initial 2021 decision that made it available by mail, which was finalized earlier this year,” Hurley wrote.
“Also under review are the 2016 decisions to extend the window in which mifepristone could be used to terminate pregnancies from seven weeks’ gestation to 10 weeks and reduce the number of in-person visits for patients from three to one,” according to Hurley, “In another 2016 move, the FDA altered the dosing regimen, finding that a lower dose of mifepristone was sufficient.”
The ADF brief
In its 63-page brief, the Alliance Defending Freedom began with this summary of the history to date:
In 2000, the Food and Drug Administration (FDA) approved mifepristone under Subpart H—the only regulatory pathway available for such approval—by labeling pregnancy a “serious and life-threatening illness.” Because the drug could not safely be approved without restrictions, the agency conditioned its approval on numerous safeguards. Yet in 2016, FDA stripped away many safeguards, failing to explain why it was proper to eliminate them all without a study showing their cumulative safety. In 2021, FDA removed the last-remaining doctor’s visit, allowing mail-order chemical abortions despite admitting the safety studies on which it relied were “insufficient.”
“Every court so far has agreed that the FDA acted unlawfully in removing common-sense safeguards for women and authorizing dangerous mail-order abortions,” said Erin Hawley, one of the ADF lawyers. “We urge the Supreme Court to do the same.”
Dr. Christina Francis, chair of the American Association of Pro-Life Obstetricians and Gynecologists, added, “The court’s decision could be a significant move toward protecting women and girls across the country from the extreme dangers of these drugs — something the FDA failed to do over the last two decades.”
In September 2023, National Right to Life released a second white paper regarding What the Media Missed in Its Coverage of the U.S. Fifth Circuit Court of Appeals Decision Regarding Mifepristone which addressed many of the issues that will be coming before the Court. That special report can be accessed here.