On April 7, Texas’ Federal Judge Matthew J. Kacsmaryk gave a preliminary ruling invalidating the drug mifepristone. The drug, approved by the Food and Drug Administration 23 years ago, is used for several indications but is most associated with safe medication abortion.
For now, the U.S. Court of Appeals for the 5th Circuit has blocked Judge Kacsmaryk’s ruling. Supreme Court Justice Samuel Alito has also passed a temporary stay that was going to expire one minute before April 20, until the Court extended the pause until the evening of Friday, April 21. As we await a ruling from the highest court in the land, vastly restricting mifepristone could be yet another blow to abortion rights.
However, mifepristone is currently used to treat a handful of conditions, including Cushing’s syndrome. Additionally, it shows promise to treat a host of conditions, from post-traumatic stress disorder (PTSD) to cancer. If SCOTUS upholds Judge Kacsmaryk’s ruling, it will affect more than those seeking medication abortions.
“It's a good drug”...“It's hard to make a case against it if you are examining the science. The only case you can really make against that is if you put in non-scientific considerations.”
What is mifepristone?
Mifepristone is a synthetic steroid. When used in conjunction with the drug misoprostol, it can serve as medication for abortions for up to 10 weeks and help manage miscarriages. Mifepristone, also known by its brand name Korlym or Mifeprex, treats adults with Cushing’s syndrome, a condition in which the body makes too much of the stress hormone cortisol and uterine fibroids, which are noncancerous growths made of muscle in the uterus. If left untreated, Cushing’s syndrome can cause blood clots in the legs and lungs, high blood pressure, type 2 diabetes, and death. Most uterine fibroids are benign in the long term but can cause anemia, chronic pelvic pain, and an increased risk of miscarriage if untreated.
“It's a good drug,” Anita Desikan, a senior analyst at the Union for Concerned Scientists covering science and public policy, tells Inverse. “It's hard to make a case against it if you are examining the science. The only case you can really make against that is if you put in non-scientific considerations.” Desikan wrote about this ruling for the UCS website.
How does mifepristone work?
At low doses, the synthetic steroid blocks progesterone from binding to other cell receptors. Blocking progesterone makes the uterine lining break down, which makes the pregnancy nonviable. It also helps misoprostol, which is taken 24 to 48 hours after mifepristone, work better. At higher doses, it blocks cortisol, which is useful in Cushing’s syndrome as well as responses in PTSD. Researchers like Rita Nanda at the University of Chicago have been investigating using mifepristone with chemotherapy in breast cancer treatment clinical trials. Researchers have also investigated its clinical use for brain cancer, prostate cancer, and alcoholism.
Those seeking medication for abortion can be prescribed mifepristone and misoprostol by telehealth consultation and obtain them by mail. According to the Guttmacher Institute, medication abortions account for more than half of all intentional pregnancy terminations in the United States.
What is mifepristone’s history?
In the 1980s, French researchers initially developed mifepristone and its companion drug for medication abortions. While France approved its use in 1988, the U.S. banned importation of the drug in 1989.
It was finally approved by the FDA in 2000, the drug has undergone policy changes, specifically loosening restrictions. Desikan points out that in March 2016, the Administration increased gestational use from 49 to 70 days, allowed at-home administration, and permitted follow-ups that aren’t necessarily in person.
In April 2021, a year into the Covid-19 pandemic, the FDA stated it would not enforce its in-person dispensing policy so those in need could access the drug by mail. By December of that year, the Administration announced it would permanently get rid of its in-person policy under the Risk Evaluation and Mitigation Strategy (REMS). This shift came in response to advocacy by the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine, according to Desika.
This past January, the FDA officially updated the REMS to do away with the in-person dispensing policy and added a certification process that would let qualified pharmacies offer mifepristone to patients with prescriptions.
What does it mean if the suspension is upheld?
Regardless of what a mifepristone prescription is meant to treat, the drug would become more difficult to access not only in states where abortion is illegal or restricted but also in states where it’s still legal. Those with Cushing’s and uterine fibroids would also need to jump hoops or lose access altogether, depending on the state.
Regardless of what a mifepristone prescription is meant to treat, the drug would become more difficult to access not only in states where abortion is illegal or restricted but also in states where it’s still legal.
Desikan says that providers can also resort to what’s known as off-label prescribing, which is when a doctor prescribes a drug for one condition that is FDA-approved for a different condition. While mifepristone would still be available for off-label prescribing, the process subjects a rigorously tested drug to the same scrutiny and regulation as a lesser-studied drug, rolling back years of scientific testing.
This ruling could also set a new legal precedent. It could upend the Chevron deference, which is a legal precedent from a 1984 case that says, according to Desikan. “Courts should have deference to agencies on administrative procedures that they're the experts in.” However, this ruling defies the Chevron deference, indicating that the courts need not defer to the expertise of an agency like the FDA.
“I'm sure everyone at some point has taken drugs for their own health and safety, right?” Desikan says. “Do you really want a process where it's not science-driven?”
Still, until the ruling comes, it’s too early to make a cut-and-dry call. “It's going to be difficult to figure out exactly how patients who need this drug can get it,” Desikan says. “It really depends on the various aspects of how the Supreme Court could rule and future types of court decisions.”
