(NEW YORK) — Well before a federal judge in Texas issued his ruling on the abortion drug mifepristone, abortion providers across the country said they had been preparing for what they called a “worst-case scenario.”
In his April 7 decision, Judge Matthew Kacsmaryk of the Northern District of Texas ruled in favor of Alliance Defending Freedom — a conservative Christian legal advocacy group — that asked him to reverse the U.S. Food and Drug Administration’s approval of mifepristone, an oral medication typically taken with misoprostol to end a pregnancy.
The advocacy group’s lawsuit said mifepristone is unsafe and that the FDA didn’t study it closely enough before approving its use. The FDA and mainstream medical doctors insist this isn’t true, and that there have been no safety concerns during the 23 years the drug has been on the market.
Now, Kacsmaryk’s issuing of a nationwide injunction on mifepristone — set to take effect by Friday — may impact as many as 64 million women of childbearing age in the U.S.
“This is something that can cause confusion. It’s something that can cause fear,” Dr. Gopika Krishna, a board-certified OB-GYN in New York, told ABC News of both the lawsuit and the judge’s decision. “And that affects our patients and our patients’ understanding of what’s available to them and what options are safe.”
Here are six questions answered by abortion providers and reproductive policy experts about how the judge’s decision may impact women:
1. If I live in a state where abortion is legal, does the Texas abortion pill ruling impact me?
Yes, the injunction on mifepristone is nationwide, affecting even states where abortion, including medication abortion, is legal.
That means drug manufacturers will have to halt production and distribution of mifepristone for the U.S. market.
Eventually, after supply of the drug dwindles, patients will not be able to access mifepristone from any provider, whether it’s via telehealth or inside a clinic.
In states where abortion is legal, providers would only be able to offer in-clinic surgical procedures or opt to provide medication abortions using only one other medication, misoprostol. Doctors say that method is safe and mostly effective but can also cause more side effects.
2. When does the ruling go into effect?
For now, mifepristone remains accessible because Kacsmaryk gave the federal government seven days to appeal his ruling.
On the same day Kacsmaryk’s decision was released, April 7, the Department of Justice and drugmaker Danco Laboratories, which produces the brand name version of the drug, appealed it to the United States Court of Appeals for the Fifth Circuit.
“Today’s decision overturns the FDA’s expert judgment, rendered over two decades ago, that mifepristone is safe and effective,” Attorney General Merrick Garland said in a statement. “The Department will continue to defend the FDA’s decision.”
GenBioPro, the manufacturer of generic mifepristone, responded to Kacsmaryk’s ruling and said they were confident in the legality of the drug.
“Nothing in the court’s order changes the decades of science and evidence regarding mifepristone’s safety and efficacy. As we review the court’s order, we will continue to make our product available,” Evan Masingill, CEO of GenBioPro, said in a statement.
3. What is mifepristone and what role does it play in medication abortion?
A medication abortion involves the use of two medications, mifepristone and misoprostol, taken orally.
It is not a surgical procedure, and the FDA says both medications are safe enough to be mailed to a patient following a telehealth or in-person visit from a certified provider.
In most cases in a medication abortion, mifepristone is taken first to block the hormone progesterone. Then 24 to 48 hours later, a second pill, misoprostol, is taken to empty the uterus.
“Mifepristone is a medication that’s been on the market for decades. It has many, many scientific articles and research that have supported it’s safety, and it’s something that is used quite often for abortion care but in other situations as well,” said Krishna, also a fellow with Physicians for Reproductive Health. “Misoprostol is a medication that, again, has been used for many, many years, has lots of good evidence and data supporting its safety, and it’s a medicine that we use not only in abortion care but in other aspects of OB-GYN care as well.”
In addition to its use in abortion care, mifepristone is also used currently for miscarriage care, according to Krishna. It remains unclear how the judge’s ruling will impact miscarriage care. The plaintiff had asked for the judge to only block the drug for purposes of abortion, but it’s possible availability will dry up since it’s primary purpose was to end a pregnancy.
The medication is also FDA-approved to treat patients with Cushing’s syndrome, a disorder in which the body makes too much of the hormone cortisol, according to the National Institutes of Health. That medication, however, is manufactured and provided to patients at a different dose. The judge’s ruling would still allow for the availability of that drug.
Guidelines from the FDA, which first approved medication abortions in 2000, advise that abortion-inducing pills are safe to use up to 70 days, or 10 weeks, of pregnancy, though evidence shows it can be safe even later in pregnancy, according to the American College of Obstetricians and Gynecologists.
While the FDA has continued to approve mifepristone for abortion care, individual states can still set laws about dispensing mifepristone within their state.
Last week, Wyoming became the first state to ban medication abortions separate from a ban on all abortion services.
4. Does the Texas ruling mean medication abortion is no longer available?
The Texas judge’s ruling means that, for now, the FDA-approved method of medication abortion — using both mifepristone and misoprostol — is available. But that could change by Friday unless the higher court intervenes.
Abortion providers told ABC News though that they are prepared to offer misoprostol-only medication abortions in states where it is allowed.
“We are preparing a misoprostol-only regimen,” said Dr. Ashley Jeanlus, a board-certified OBGYN in California. “The misoprostol regimen is a bit longer and it utilizes more pills to complete it, so we’re just adjusting our clinic to be able to help patients that way.”
More than one dozen states currently restrict access to medication abortion, according to the Guttmacher Institute .
5. What is misoprostol?
Misoprostol is a medication that the FDA currently approves for the use of treating gastric ulcers.
However, there are several off-label uses for obstetrical and gynecological purposes including treating postpartum hemorrhaging and softening and opening the cervix for patients ready to give birth vaginally, experts told ABC News.
When it comes to its use in pregnancy, misoprostol causes the uterus to contract and dilates the cervix, which will expel an embryo.
A misoprostol-only regimen for abortion not only takes longer to complete, but can also come with more side effects, including nausea and diarrhea, Dr. Laura Laursen, an OB-GYN at Rush University Medical Center in Chicago, previously told ABC News.
Studies though show that while using misoprostol with mifepristone is more effective, using misoprostol-only is safe. One 2019 study found “misoprostol alone is effective and safe and is a reasonable option for women seeking abortion in the first trimester,” while a larger review of data published in 2020 also found it safe and effective in terminating a pregnancy.
Rachel Jones, principal research scientist at the Guttmacher Institute, said in many cases, it will not be a quick fix for abortion providers to pivot to using a misoprostol-only regimen.
“It’s not a regimen that has been used in clinical settings in the U.S. very often,” Jones said, adding, “And anytime a medical practice is changed, it takes it a while for everything to get in place and running smoothly.”
Krishna said she worries the judge’s ruling means providers like herself will not be able to offer patients comprehensive reproductive care.
“As clinicians, we really want to make sure that we are offering our patients all of these options and they can make a decision based on what they feel is best for them, not a decision that they have to make because of what’s limited to them by law,” she said. “So there are options for medication abortion with the removal of mifepristone, but it is still something that we’re really worried about because it’s the medically unnecessary removal of a medication that we know is safe.”
6. Could the Texas judge’s abortion pill ruling be overturned?
Yes, the ruling can go through an appeals process, meaning it would move to higher courts for other judges to decide.
Jones said that for abortion rights advocates, there is “not a lot of hope” for the appeals process given previous rulings by courts that would see the case.
Ultimately, the case could go as high as the U.S. Supreme Court, the same court that last year overturned Roe v. Wade, the constitutional right to abortion that had been the law in the U.S. for almost 50 years.
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