U.S. District Judge Matthew Kacsmaryk on Friday suspended the Food and Drug Administration’s approval of the abortion pill mifepristone, giving the government a week to appeal his decision.
If Kacsmaryk’s ruling does go into effect, it would block access to medication abortion nationwide. The pills have become increasingly significant since the Supreme Court’s decision to overturn Roe v. Wade last June.
President Joe Biden on Friday said his administration would fight the ruling.
“This does not just affect women in Texas – if it stands, it would prevent women in every state from accessing the medication, regardless of whether abortion is legal in a state,” Biden said in a statement. “My Administration will fight this ruling. The Department of Justice has already filed an appeal and will seek an immediate stay of the decision.”
Several anti-abortion groups have challenged the process through which the FDA evaluated and approved mifepristone.
“The Court does not second-guess FDA’s decision-making lightly,” Kacsmaryk wrote. “But here, FDA acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions.”
If the ruling does stand, it would mean the drug would no longer be available anywhere in the U.S., limiting abortion options to a surgical procedure or off-label use of misoprostol.
Misoprostol, a drug that would have to be approved by doctors, is not FDA-approved to terminate pregnancies on its own. Friday night, the Department of Justice filed a notice of appeal to the 5th Circuit Court of Appeals.
“Today’s decision overturns the FDA’s expert judgment, rendered over two decades ago, that mifepristone is safe and effective. The Department will continue to defend the FDA’s decision,” Attorney General Merrick Garland said in a statement.
The move comes as Democrats prepare to put women’s rights as a massive issue in the 2024 election.
