A federal judge in Texas issued a preliminary ruling invalidating the Food and Drug Administration’s 23-year-old approval of the abortion pill mifepristone, an unprecedented order that — if it stands through court challenges — could make it harder for patients to get abortions in states where abortion is legal, not just in those trying to restrict it.
The drug will continue to be available at least in the short-term because the judge, Matthew Kacsmaryk, stayed his own order for seven days to give the F.D.A. time to ask an appeals court to intervene.
Less than an hour after Judge Kacsmaryk’s ruling, another federal judge, in Washington State, issued a ruling that directly contradicted the Texas decision, ordering the F.D.A. to make no changes to the availability of mifepristone.
The conflicting orders by two federal judges appear to create a legal standoff likely to escalate to the Supreme Court.
The order by Judge Kacsmaryk, a Trump appointee who has written critically about Roe v. Wade, is an initial ruling in a case that could result in the most consequential abortion decision since the Supreme Court overturned Roe v. Wade last June.
The lawsuit, filed by a coalition of anti-abortion groups and doctors, seeks to end more than 20 years of legal use of mifepristone, the first pill in the two-drug medication abortion regimen.
The lawsuit in Washington State was filed against the F.D.A. by a dozen Democratic attorneys general. In a preliminary injunction in that case, Judge Thomas O. Rice blocked the agency from taking “any action to remove mifepristone from the market or otherwise cause the drug to become less available.”
Medication abortion is the method used in more than half of abortions in the United States. The lawsuit claims that the F.D.A. did not adequately review the scientific evidence or follow proper protocols when it approved mifepristone in 2000 and that it has since ignored safety risks of the medication.
Legal experts said that even if the Texas ruling is ultimately upheld, there would be several legal options that could allow the manufacturers of mifepristone to continue supplying the drug and providers to continue prescribing it to patients.
And if legal access to mifepristone is blocked, some abortion providers plan to provide only the second abortion medication, misoprostol, which is used safely on its own in many countries where mifepristone is less available. Misoprostol, a drug that is approved for other medical uses, causes contractions similar to a miscarriage and is considered slightly less effective on its own than in combination with mifepristone and more prone to cause side effects like nausea.
In the Texas lawsuit, the plaintiffs also seek to ban the use of misoprostol for abortion, but their request for a preliminary injunction focused on mifepristone.
Since last year’s Supreme Court ruling overturning the national right to abortion, the pills used in medication abortions have increasingly become the focus of political and legal battles. Some conservative states, in addition to banning or restricting abortion in general, have begun considering legislation that specifically targets abortion pills. And several recent lawsuits have been filed in efforts to preserve or expand access to medication abortion.
The F.D.A. and the Justice Department have strongly disputed the claims in the lawsuit and said that the federal agency’s rigorous reviews of mifepristone over the years had repeatedly reaffirmed its decision to approve mifepristone, which blocks a hormone that allows a pregnancy to develop. In a court filing in the case, the F.D.A. said that overturning its approval of mifepristone would “cause significant harm, depriving patients of a safe and effective drug that has been on the market for more than two decades.”
The case has caused a frenzy of concern in the reproductive health community. It was filed by the Alliance for Hippocratic Medicine, an organization that lists five anti-abortion groups as its members and was incorporated in August in Amarillo, Texas, where the case was filed. Judge Kacsmaryk is the only federal judge covering the Amarillo division in the court’s Northern District.
The F.D.A. has regulated mifepristone more stringently than many other drugs and has regularly reviewed evidence for its safety and effectiveness.
For a dozen years, the agency has imposed an additional framework of restrictions and monitoring for the drug. Called a Risk Evaluation and Mitigation Strategy, or REMS, that framework has been used for only about 300 other drugs, only 60 of which it currently covers.
In recent years, the F.D.A. has extensively reviewed new data on mifepristone and has lifted several of the restrictions, including the requirement that patients obtain the drug in person from a provider.
Some of the same anti-abortion organizations that filed the Texas lawsuit had previously filed, in 2002 and 2019, citizen petitions opposing the F.D.A.’s actions on mifepristone. Both were rejected by the agency as unfounded. And a 2008 review by the Government Accountability Office found no irregularities in the F.D.A.’s mifepristone approval.
Legal experts said that the ruling appeared to be the first time that a court had acted to order that a drug be removed from the market over the objection of the F.D.A. and that if the ruling stood, it could have repercussions for federal authority to regulate other types of drugs.
Adam Liptak contributed reporting.