Dueling court orders released on Friday have increased uncertainty over the fate of mifepristone, a key component of medical abortions.
A federal judge in Texas ruled that the Food and Drug Administration's approval of the synthetic hormone used to stop progesterone production and terminate pregnancies should be overruled. Mifepristone has been an FDA-approved medication for over 20 years.
Judge Matthew Kacsmaryk of the Northern District of Texas said that a preliminary injunction blocking the FDA’s approval would serve the public interest.
“To the extent Defendants and third parties would be harmed by an injunction, the Court still balances these factors in favor of ensuring that women and girls are protected from unnecessary harm and that Defendants do not disregard federal law,” wrote the judge in his decision.
Kacsmaryk wrote that the “FDA shirked any responsibility for the consequences of its actions by eliminating any requirement that non-fatal adverse events be reported.”
“Thus, FDA took its chemical abortion regimen which had already culminated in thousands of adverse events suffered by women and girls and removed what little restrictions protected these women and girls, systematically ensuring that almost all new adverse events would go unreported or underreported,” wrote Kacsmaryk, who was appointed by President Donald Trump.
The legality of the FDA’s approval of mifepristone was challenged by the Alliance Defending Freedom. The ADF argued the FDA ignored petitions for review for almost 6,000 days, or 16 years. The legal advocacy organization contends that mifepristone is unsafe and was not studied sufficiently before receiving FDA approval in 2000.
Kacsmaryk gave the federal government seven days to appeal his ruling, which is accordingly scheduled to take effect on April 14.
Hours after the Texas judge released his decision, a federal judge in Washington ordered the FDA to maintain its approval of mifepristone.
District Court Judge Thomas Rice said the nationwide injunction was “inappropriate where there is the potential for competing litigation.” Rice said his ruling applies only to Washington, D.C. and the 17 states that have sued the federal government for the right to expand access to the abortion pill, per AP News.
Rice was appointed by President Barack Obama.
The issue is likely to be decided by the Supreme Court.
Mifepristone is part of a two-drug regime used for medical abortions. A second drug, misoprostol, causes cramping and contractions to trigger a woman’s body to expel a fetus that was terminated by mifepristone.
Mifepristone was approved by the FDA on Sept. 28, 2000. Medical abortion accounted for over half of all abortions in America in 2022.
The Biden administration has vowed to fight Kacsmaryk's ruling.
“We want the courts to overturn this reckless decision,” Xavier Becerra, President Joe Biden’s health secretary, told CNN. “We intend to do everything to make sure it’s available to them not just in a week, but moving forward, period, because mifepristone is one of the safest and most effective medicines that we have seen over the last 20 years to help women with their health care, especially abortion care."
