Q&A on the Medication Abortion Court Rulings

More than half of abortions in the U.S. are medication abortions, done early in pregnancies. But less than a year after the Supreme Court overturned Roe v. Wade, federal court rulings have raised questions about the future availability of mifepristone, the first of the two-drug combination used in those abortions.

On April 7, a District Court judge suspended the Food and Drug Administration’s approval of mifepristone, which occurred 23 years ago, while another judge ruled in a separate case that the FDA couldn’t change the current availability of the drug. Less than a week later, an appeals court gave both sides part of what they wanted: The court said the FDA’s approval would remain valid, but the agency’s later changes to increase access to the drug would still be suspended while the case proceeds.

The federal government and the drugmaker have appealed that decision to the Supreme Court. The restrictions on mifepristone, as ordered by the appeals court, would take effect on April 15, unless the Supreme Court intervenes.

Update, April 21: The U.S. Supreme Court, by a 7-2 vote, stayed the lower court’s ruling on April 21. That means no restrictions on the FDA regulations of mifepristone during the appeals process.

Here we answer questions about the court rulings, mifepristone and what may happen next.

What is mifepristone?

Mifepristone, sold under the brand name Mifeprex and also known as RU-486, is a drug approved by the FDA to terminate pregnancies through 10 weeks (70 days) of gestation. It’s the first of two medicines that are taken together as part of medication or medical abortion in the U.S.

In the FDA-approved regimen for medication abortion, one mifepristone pill is taken by mouth on the first day. Between 24 and 48 hours later, the patient places two tablets of another medicine called misoprostol in each cheek pouch, and lets them dissolve. Patients typically begin to expel pregnancy tissue two to 24 hours after taking the second drug. Patients then follow-up with their health care provider a week or two after taking mifepristone to ensure that the pregnancy has been successfully terminated.

Mifepristone ends pregnancies by blocking the hormone progesterone, which is required to maintain a pregnancy. Without the progesterone signal, the uterine lining with the implanted embryo or fetus is shed. Mifepristone also makes the uterine muscle more sensitive to prostaglandins, including misoprostol, which triggers contractions and helps open the cervix. 

In some countries, misoprostol is used alone in medication abortions, but research shows the drug combo is more effective and may have fewer side effects. While FDA’s approved mifepristone regimen requires misoprostol, misoprostol is not FDA-approved for abortion, so technically it is used off-label for that purpose. Off-label prescribing, which is common, is when a doctor prescribes a drug in a different way or for a different condition than the one for which it was approved.

Outside of medication abortion, mifepristone is used off-label or  expel pregnancy tissue and avoid procedures. The pill is also  to treat high blood sugar in certain Cushing’s syndrome patients.