What to know about the Texas abortion pill ruling, its impact on access
A federal judge in Texas is likely to rule soon in a case that could halt distribution of a key abortion drug - a decision that would have sweeping implications for abortion access across the country, including in Democratic-led states where abortion rights are protected.
The lawsuit, filed by several antiabortion groups and doctors against the U.S. Food and Drug Administration, aims to undo the decades-old government approval of mifepristone, one of the two drugs used in a medication abortion.
If the judge in the case, Matthew Kacsmaryk of the Northern District of Texas, sides with antiabortion groups, abortion rights advocates say, the implications would be "catastrophic" - imposing the furthest-reaching limit on abortion access since the Supreme Court overturned Roe v. Wade in June.
Here's a look at the case, and how it could shape abortion care nationwide:
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What does the lawsuit allege?
The FDA has repeatedly deemed the two-step medication abortion protocol to be safe and effective. But the lawsuit argues that the regulatory agency never should have approved mifepristone back in 2000, claiming the government purposely ignored what the plaintiffs contend are harmful side effects.
Leading organizations of physicians and other public health professionals have strongly disputed those allegations, telling Kacsmaryk that reversing FDA approval of mifepristone would "cause profound and irreparable harm to patients across the country." Medication abortions with mifepristone have "an exceptionally low rate of complications," according to their brief.
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How could the ruling affect abortion access?
Medication abortions - a two-step regimen of mifepristone and misoprostol - now account for more than 50 percent of legal abortions nationwide.
If Kacsmaryk halts access to mifepristone, patients would no longer be able to legally access the standard two-step regimen at abortion clinics or pharmacies or through the mail. At clinics, many of which currently provide both medication and surgical abortions, providers expect longer wait times for patients and a mad rush to vet and implement new procedures for terminating pregnancies.
Clinics could either limit their offerings to surgical abortions - which require far more time and resources than pills - or introduce a new medication abortion protocol that only includes misoprostol. While misoprostol is widely used on its own to perform abortions around the world, studies show it is less effective than the two-step regimen, and usually causes more cramping and bleeding.
In a recent column in Slate, several prominent law professors who specialize in abortion predicted that the immediate impacts of a ruling against the FDA could be considerably less dramatic. While Kacsmaryk could order the agency to start withdrawing its approval for the drug, they write, the process is lengthy and requires hearings and FDA deliberations. Even if the drug loses its official approval, they added, the agency could allow it to stay on the market under a policy known as "enforcement discretion," which the FDA sometimes uses for products that don't pose safety concerns.
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Could the lawsuit affect the FDA more broadly?
The Justice Department wrote in a court filing that the lawsuit has the potential to undermine the country's process for regulating pharmaceuticals. If the courts side with conservative groups, it could create what some experts say is an unprecedented situation: ordering the FDA to remove a medication from the market despite opposition from the agency and the drug's manufacturer.
Congress created an "onerous and difficult process" for the FDA to take an approved drug off the market, according to Greer Donley, a professor at the University of Pittsburgh School of Law and one of the authors of the Slate column - which means that, once the FDA approves a medication, drug manufacturers can reasonably assume the approval is permanent and binding.
"[If] one judge, who literally has no scientific background, can come in and circumvent that whole process and order the FDA to remove a product from the market, it's just potentially very concerning," Donley said.
She cited concerns about potential backlash to drugs for stigmatized conditions, such as PrEP to reduce the risk of contracting HIV or drugs for gender-affirming care: "This really does have the potential to disrupt a lot of the assumptions that are baked into the drug-approval process."
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How can one judge in Texas issue a nationwide ruling?
The decisions of individual district court judges typically apply only to the specific parties in a case, but their rulings can sometimes have national implications. Nationwide injunctions - which have become increasingly common and controversial in recent years - are typically issued to block broad enforcement of a federal statute or policy.
Still, in a high-stakes case like this one, a federal district court judge is rarely the final stop. However Kacsmaryk rules, the case probably will be appealed to the conservative U.S. Court of Appeals for the 5th Circuit, and could eventually make its way to the Supreme Court.
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Isn't abortion legally protected in many blue states?
Yes. But state laws only protect access to abortion in a general sense, according to legal experts. They don't protect any particular form of abortion, allowing Kacsmaryk to halt use of mifepristone from California to Illinois to New York.
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What more do we know about Judge Kacsmaryk?
The judge for the Amarillo division of the Northern District of Texas, Kacsmaryk was nominated by President Donald Trump. Since joining the federal bench in 2019, he has delivered a number of high-profile wins for conservative groups on issues such as contraception and immigration. His nomination drew sharp criticism from Democrats on the Senate Judiciary Committee, who quizzed Kacsmaryk on the anti-LGBTQ statements he had made while working for the First Liberty Institute, a conservative legal advocacy group.
A recent Washington Post story on Kacsmaryk, based on 20 interviews with people who know him, revealed that he has been deeply opposed to abortion since his young adulthood.
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Who brought the lawsuit?
The conservative legal group Alliance Defending Freedom brought the lawsuit on behalf of four antiabortion organizations and four doctors who say they have treated patients with mifepristone.
Abortion rights advocates have accused the group of "judge shopping," filing in Kacsmaryk's district because they believe the judge may be more inclined than others to rule favorably in the case. Lawyers for Alliance Defending Freedom would not say whether Kacsmaryk's presence affected their decision to file in Amarillo.
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When is the ruling expected?
All the briefs in the case have been filed, which means a ruling could come any day.
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How does medication abortion work?
In a two-step medication abortion, a patient first takes one mifepristone pill, which terminates the pregnancy. About 24 hours later, the patient typically takes a four-pill dose of misoprostol, a drug introduced in 1973 to treat stomach ulcers, to soften the cervix and prompt contractions that expel the fetus. The misoprostol-only medication abortion procedure requires three doses of four misoprostol pills each.
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