Here’s what to know about the case, how we got here, and what could be next.
A group of conservative organizations filed a lawsuit questioning whether the Food and Drug Administration followed proper protocols and scientific evidence when deciding how to regulate mifepristone — one of two drugs used in medication abortions, which make up more than half of the pregnancy terminations in the United States.
The groups say that the drug is dangerous and should never have been permitted to be available to American consumers — an argument sharply refuted by mainstream medical groups, based on two decades of accumulated scientific evidence. The lawsuit asks the courts to order the FDA to revoke its approval of mifepristone, removing the abortion pill from the American marketplace.
The Justice Department, independent health advocates and pharmaceutical companies have strongly opposed the lawsuit, saying mifepristone is overwhelmingly safe and that it would be a dangerous precedent for a court to interfere with the FDA’s oversight authority.
How did it get to the Supreme Court?
The conservatives groups initially filed the case in Amarillo, Tex., a courthouse with one judge, U.S. District Judge Matthew J. Kacsmaryk, a nominee of President Donald Trump with strong antiabortion views.
Kacsmaryk ruled in favor of the groups, ordering the FDA to revoke its approval of mifepristone.
The Biden administration appealed to the U.S. Court of Appeals for the 5th Circuit, asking a panel of judges to pause Kacsmaryk’s ruling until the appeals process is concluded. (The appeal of any federal Texas case goes to the 5th Circuit, based in New Orleans.)
The 5th Circuit blocked Kacsmaryk’s order to the FDA to revoke approval of the drug, but did not grant the Biden administration’s request to preserve full access to mifepristone. Instead, it imposed significant restrictions on how and when people can obtain the drug. Among them: People can no longer obtain the pill by mail or have it prescribed by medical professionals who are not doctors, and can use it up until seven weeks of pregnancy, instead of the current 10 weeks.
The Biden administration then asked the Supreme Court to stay that ruling and restore full access to the pill while the lower courts consider the appeal of Kacsmaryk’s decision.
Is there other litigation involving abortion medication?
This is where it gets even more complicated. Just after Kacsmaryk issued his ruling, another judge in Washington state delivered a conflicting ruling in what can be viewed as a dueling abortion pill lawsuit. In the Washington state case, 17 states with Democratic attorneys general — and the District of Columbia — accused the FDA of wrongfully imposing too many restriction on mifepristone.
The lawsuit, which seeks to make it even easier to distribute the medication to patients, also was opposed by the Justice Department, which again argued that the FDA knows what it is doing and that courts shouldn’t interfere.
Judge Thomas O. Rice in Washington state, who was nominated by President Barack Obama, agreed. He said the FDA should preserve “the status quo,” retaining access to mifepristone in those 17 states and D.C.
It is unclear how the rulings by Kacsmaryk or the 5th Circuit would coexist with Rice’s order. But the coalition of Democratic state attorneys general says that if the dual rulings take effect, they would expect the FDA to preserve access to mifepristone in their states — even if it becomes prohibited in other ones.
The Supreme Court is acting only on a request to put the 5th Circuit ruling on hold, and the Washington state ruling was not in front of it.
Will the Texas case affect drugs that are not abortion medication?
Kacsmaryk’s ruling marks the first time a judge has ordered the FDA to revoke the approval of a drug, and experts say that it could politicize the agency and undermine its ability to approve medication that Americans rely on every day. This could, they said, open the door for people to file lawsuits when they do not like a medication that is on the market — even if that medication has repeatedly been deemed safe.
Here’s what President Biden said in a statement: “If this ruling were to stand, then there will be virtually no prescription, approved by the FDA, that would be safe from these kinds of political, ideological attacks.”
What is the second abortion drug, misoprostol, and will it be affected?
Mifepristone is one of two drugs used in the standard two-step medication abortion regimen. The other is misoprostol, which is not affected by this ruling.
Many abortion clinics say that if they are forced to stop providing mifepristone they will continue to provide surgical abortions and, in many cases, a different medication abortion regimen that includes only misoprostol.
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 embryo or fetus.
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.
Does this debate affect access to the morning-after pill?
No, because morning-after pills are considered emergency contraceptives, not medications to terminate pregnancies. The commonly used over-the-counter drug contains the synthetic hormone, progestin, which can prevent pregnancy if taken as soon as possible after having unprotected sex. It works by stopping or delaying ovulation, according to the American College of Obstetricians and Gynecologists.
The FDA in December announced it would overhaul packaging labels for Plan B One-Step, an over-the-counter emergency contraceptive, to clarify that scientific evidence shows “no direct effect on fertilization or implantation.” The agency said the pill “will not work if a person is already pregnant, meaning it will not affect an existing pregnancy.”
Prior to that decision, the labeling on packages of Plan B and generic versions had suggested the pills work mainly by stopping the release of an egg from the ovary, or possibly by preventing fertilization. But it had also suggested that if an egg is fertilized, the drug might prevent it from attaching to the wall of the uterus. Some abortion opponents had used the latter claim to argue the medication causes abortions and should be restricted.
What is the Comstock Act and how is it involved with this case?
The Comstock Act is a Civil War-era federal law that originally prohibited the mailing of birth control, “lewd” or “obscene” material, and anything intended for abortion. It’s been whittled away over the years by the courts and Congress, but it’s still on the books, and antiabortion advocates have begun citing it to argue that it’s technically illegal to mail the abortion pill regimen.
Justice Department lawyers have argued that mailing abortion pills does not violate the Comstock Act, in part, because senders cannot know if the recipient would use it illegally. They said abortion medication has other uses beyond terminating pregnancies and every state has exceptions for when abortions can be legally terminated, making it impossible to definitely know how any one person will use them.
But Kacsmaryk argued in his ruling that the law says you can’t mail items intended for abortion. So even if the FDA had correctly approved abortion medication, he argued, it’s illegal to mail it.
Robert Barnes contributed to this report.
