On Apr. 7, just before the holiday weekend, a federal judge in Texas delivered a long-awaited ruling with an unprecedented (and, to health experts, baseless) conclusion: that mifepristone, a drug used in more than half of all abortions performed in the U.S., had not been properly approved by the U.S. Food and Drug Administration (FDA) 23 years ago. The temporary withdrawal of the drug, expected to go into effect on Apr. 14 if no legal challenges succeed in the days beforehand, would immediately take the most commonly used abortion method off the table across the country.
Here’s what to know about the drug and its imperiled legal status.
What is mifepristone?
Mifepristone, which blocks the womb’s receptors for the hormone progesterone, is the first part of a two-step medication regimen used to end pregnancies in the U.S. at up to 10 weeks. It’s generally taken shortly before a second pill, misoprostol (which is not FDA-approved for use in abortions but is used off-label for that purpose), which causes cramping and bleeding and empties the uterus.
Currently, mifepristone is the only drug approved by the FDA for use in abortion. Changes made by the Biden Administration in recent years have attempted to expand access to the medication, but the recent lawsuit, filed by the anti-abortion physician’s group Alliance for Hippocratic Medicine (AHM) in Nov. 2022, seeks to do the opposite. Legal experts say that the decision to file the suit in conservative judge Matthew Kacsmaryk’s jurisdiction in Amarillo, Texas, was intentional in order to secure a favorable ruling, and the 67-page ruling Kacsmaryk handed down contained many of the pro-life arguments and lingo that opponents of the verdict expected to see.
What changes now?
The court issued a weeklong pause on Kacsmaryk’s ruling in order to allow time for appeals, so nothing about mifepristone’s availability will change until at least Apr. 14. But the legal status of the drug is very much in flux. Shortly after Kacsmaryk’s ruling, a second case addressing access to all abortion pills was decided in Washington state, where a judge ordered the federal government to keep the drugs available in more than a dozen states. On Apr. 10, the Justice Department requested clarification from the Washington judge as tensions continued to grow between the outcomes of the two cases. These seemingly contradictory orders have created an atmosphere of uncertainty surrounding the abortion options that will be available to people in the U.S. as soon as next week.
How would abortions change without mifepristone?
Clinics are preparing for any number of changes. “I think we don’t know exactly what will happen if the judge’s order takes effect,” said Jennifer Dalven, director of the ACLU Reproductive Freedom Project, on an Apr. 10 press call. “What we do know is that there will be significant confusion and chaos as providers try to provide the best care that they possibly can for their patients.”
For a shorter term solution, some Democratic states are preparing by stockpiling mifepristone pills in case it’s taken off the market immediately. Bloomberg Law reported on Apr. 10 that Massachusetts will stockpile at least 15,000 doses of mifepristone
It is possible to have a medication abortion using only misoprostol. “Some providers are prepared to switch to a misoprostol-only regimen,” said Jenny Ma, senior counsel at the Center for Reproductive Rights on an Apr. 10 press call. This alternative method isn’t new, and it’s used regularly in countries outside the U.S. But it can be more complicated, and more painful, than the two-pill regimen, and experts fear that if providers are forced to spend valuable time reevaluating what their clinics are safely and legally able to offer under changing guidelines, many women may miss out on opportunities for care.
Though two-pill medication abortion is the preferred method, misoprostol-only abortions have been found to be just as safe. But they’re not as effective. A Feb. study in the journal Perspectives on Sexual and Reproductive Health found that misoprostol-only abortions using medications provided by a telemedicine service were only 88% effective, while the two-drug regimen is effective nearly 100% of the time.
It can also be more painful. Many of the physical side effects associated with the two-step regimen can be attributed to the contraction-causing discomfort of misoprostol. For many pregnant people, this can include symptoms like nausea, diarrhea, and especially cramping and bleeding. Without the progesterone-blocking effects of mifepristone, these symptoms can be worse.
A single-drug regimen could also have a narrower window of use, based on what providers are comfortable overseeing. The two-drug regimen’s use window— up to 10 weeks of pregnancy—is dictated by mifepristone’s approval guidelines, but because misoprostol is only FDA approved for other purposes such as ulcer prevention, limits on its use for abortion would be entirely determined by physicians’ best practices and state laws. With lower efficacy rates and worse side effects for misoprostol-only regimens, providers could be more inclined to recommend surgical options (which are often more expensive and can be more difficult to access) for patients who are further along in their pregnancies.
“If mifepristone becomes inaccessible, there will be a massive shock to the provision of care in the states where abortion access remains,” Ma said. “What we do know is that there will be significant confusion and significant delays in people being able to access care.”
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