Two federal judges have issued conflicting rulings on whether FDA's approval of the abortion pill mifepristone is valid, an issue that's likely to end up before the Supreme Court.

Details on the rulings

In one lawsuit filed in Texas, Judge Matthew Kacsmaryk issued a ruling invalidating FDA's approval of mifepristone, arguing the agency didn't adequately review scientific evidence or follow the proper protocols when it approved the drug in 2000.

" F.D.A. 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," Kacsmaryk said in his ruling. "There is also evidence indicating F.D.A. faced significant political pressure to forgo its proposed safety precautions to better advance the political objective of increased 'access' to chemical abortion."

Meanwhile, in a lawsuit filed in Washington state by 18 Democratic attorneys general challenging FDA's restrictions on prescribing and dispensing mifepristone, Judge Thomas Rice blocked FDA from taking "any action to remove mifepristone from the market or otherwise cause the drug to become less available."

The suit aimed to eliminate restrictions FDA has applied to mifepristone, but also requested the judge declare FDA's "approval of mifepristone is lawful and valid" and to enjoin FDA "from taking any action to remove mifepristone from the market or reduce its availability."

Reaction to the rulings

In response to the Texas ruling, President Biden said the decision "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."

In a statement, FDA said it "stands behind its determination that mifepristone is safe and effective under its approved conditions of use for medical termination of early pregnancy, and believes patients should have access to FDA-approved medications that FDA has determined to be safe and effective for their intended uses."

Jessica Ellsworth, a lawyer for  Danco Laboratories, which makes the branded version of mifepristone called Mifeprex, said the ruling "rewrites the facts and the law to tell its preferred narrative — which is a story line that conflicts with established legal principles and with Mifeprex's well-established safety profile."

Erik Baptist, a lawyer for the anti-abortion groups that filed the Texas lawsuit, said the ruling is "a significant victory for the doctors and medical associations we represent, and more importantly, the health and safety of women and girls." He added that "by illegally approving dangerous chemical abortion drugs, the FDA put women and girls in harm's way, and it's high time the agency is held accountable for its reckless actions."

What's next

Judge Kacsmaryk stayed his own ruling to give FDA seven days to seek an appeal. On Friday, the  Justice Department, which represents FDA, filed a notice saying it's appealing the ruling.

If the appeals court upholds Kacsmaryk's ruling or declines to pause it until the full case is heard, the Justice Department is likely to appeal to the Supreme Court, which will take into account both Kacsmaryk's and Rice's rulings, experts said.

It's also possible that FDA could choose not to enforce Kacsmaryk's ruling, as legal experts say the agency has the authority to decide not to enforce a regulation or prohibition of a drug if FDA considers the drug to be safe and effective.

When asked about that possibility, HHS  Secretary Xavier Becerra said "Everything is on the table. The president said that way back when the Dobbs decision came out. Every option is on the table."

Since the ruling only applies to FDA and not abortion providers, several medication abortion services have said they'll still prescribe and dispense mifepristone unless FDA decides to withdraw the drug from the market.

Experts said the two companies that make mifepristone in the United States, Danco and  GenBioPro, could also file a lawsuit against FDA to block its enforcement of the Texas ruling.

If access to mifepristone is ultimately blocked, some abortion providers intend to provide only the second abortion medication, misoprostol, which is used on its own around the world in places where mifepristone is harder to access.

In response to the Texas ruling, House Democrats on Monday said they will introduce a bill affirming that FDA has the final say when it comes to approving drugs used in medication abortion.

"This legislation will reaffirm the FDA's approval authority and protect doctors who use telemedicine to prescribe medication abortion," said Rep. Pat Ryan (D-N.Y.), who is co-sponsoring the bill with Rep. Lizzie Fletcher (D-Texas). (Belluck, New York Times, 4/7; Belluck, New York Times, 4/9; VanSickle/Belluck, New York Times, 4/8; Gonzalez, Axios, 4/10; Sforza, The Hill, 4/9)