WASHINGTON — The Supreme Court is set to consider the accessibility of the abortion pill mifepristone in a significant challenge to the FDA's drug approval process.
With a 6-3 conservative majority, the court will hear arguments regarding the Biden administration's appeal of lower court rulings that restricted access to the pill, including its availability by mail. Mifepristone is a key component of the FDA-approved regimen for most abortions in the U.S.
This case represents a critical test for the conservative-leaning court, which overturned Roe v.
Wade in 2022, a landmark ruling that affirmed a woman's constitutional right to terminate her pregnancy. Represented by the Alliance Defending Freedom, a conservative Christian legal group, a group of anti-abortion doctors is leading the legal challenge, arguing that the FDA did not adequately assess the drug's safety risks.
The pharmaceutical industry supports the FDA, cautioning that judicial interference in the approval process could disrupt operations and discourage innovation. Danco, the manufacturer of the brand version of the pill, Mifeprex, is aligned with the FDA in the oral arguments.
The oral argument follows a ruling by U.S. District Judge Matthew Kacsmaryk in Texas, which invalidated the FDA's approval of the pill, causing concern among abortion rights activists that the drug might be banned entirely.