A conservative advocacy group called Alliance Defending Freedom filed a lawsuit in Texas against the use of the abortion pill Mifepristone, an oral medication approved by the U.S. Food and Drug Administration (FDA) to terminate a pregnancy.
In his decision on April 7, Judge Matthew Kacsmaryk of the Northern District of Texas ruled in favor of Alliance Defending Freedom and prohibited the sale and distribution of Mifepristone.
The argument accepted by the judge from the advocacy group is that Mifepristone is not a safe medication and that the FDA did not study it sufficiently before approving its use. The FDA states that this is not true and that there have never been concerns about the “safety” of the drug during the 23 years it has been on the market.
How will the Texas judge’s decision impact women across the country?
1. If I live in a state where abortion is legal, does the ban on the distribution of abortion pills from Texas affect me?
Yes, the injunction on Mifepristone is national, affecting even states where abortion, including medication abortion, is legal.
This means that manufacturers of the drug will have to halt production and distribution of Mifepristone for the entire North American market.
In states where abortion is legal, women will only have access to abortion through surgical procedures at a clinic or may opt for another type of medication, Misoprostol, which is also considered safe and effective according to doctors, but may also cause more side effects.
2. When does the decision take effect?
For now, Mifepristone remains accessible because the judge gave the federal government seven days to appeal his decision. This means that if the appeals court upholds the Texas judge’s decision, starting this Friday, the drug will begin to have its sale and distribution blocked.
The U.S. Department of Justice requested on Monday (11) that the Fifth Circuit federal appeals court keep Mifepristone on the market while the litigation unfolds and indicated that it may seek intervention from the Supreme Court.
“The (judge’s) decision overturns the FDA’s expert opinion, issued more than two decades ago, that Mifepristone is safe and effective,” said Attorney General Merrick Garland in a statement. “The Department will continue to defend the FDA’s decision.”
3. What is Mifepristone and what role does it play in medication abortion?
A medication abortion typically involves the use of two medications, Mifepristone and Misoprostol, taken orally.
It is not a surgical procedure, and the FDA states that both medications are safe enough to be given to a patient after a virtual or in-person consultation with a certified provider.
In most cases of 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 has been on the market for decades. There are many, many scientific articles and research supporting its safety, and it is something that is used quite frequently for abortion, but also in other situations,” Dr. Krishna, a member of Physicians for Reproductive Health, told ABC News.
In addition to its use for medication abortions, Mifepristone is also used for miscarriage management. It is still unclear how the judge’s decision will affect miscarriage care. The advocacy organization asked the judge to block the drug only for the purposes of induced abortions.
The FDA, which first approved the use of the medication in 2000, recommends that abortion-inducing pills be used up to 70 days or 10 weeks of pregnancy, although there is evidence that they may be safe even later in pregnancy, according to the American College of Obstetricians and Gynecologists.
Regardless of FDA approval, states can establish their own laws regarding the distribution of Mifepristone within their territory.
4. Does the Texas decision mean that medication abortion is no longer available?
The Texas judge’s decision means that, until Friday, the FDA-approved medication abortion method – using both Mifepristone and Misoprostol – is available. From there, everything will depend on the appeals court’s decision.
Abortion providers told ABC News that they are prepared to offer medication abortions using only Misoprostol in states where it is permitted.
5. What is Misoprostol?
Misoprostol is a medication that the FDA currently approves for use in the treatment of gastric ulcers.
However, there are several “off-label” uses for obstetric and gynecological purposes, including the treatment of postpartum hemorrhage and softening and opening the cervix for patients ready to give birth vaginally, according to experts.
When it comes to its use in pregnancy, Misoprostol causes the cervix to dilate to expel the embryo.
An abortion induced solely with Misoprostol takes longer to complete and may come with more side effects, including nausea and diarrhea, according to experts consulted by ABC News.
Studies show that while the use of Misoprostol with Mifepristone is more effective, the exclusive use of Misoprostol is safe. A 2019 study found that “Misoprostol alone is effective and safe and is a reasonable option for women seeking abortion in the first trimester.”
Source: ABC News