Why is the most effective medication used in miscarriage care so difficult to get?

One of the most common complications of pregnancy is miscarriage. According to the Yale School of Medicine, 1 million out of 5 million pregnancies in the United States end in miscarriage or the loss of a fetus before 20 weeks’ gestation. 

However, the most effective drug used in miscarriage care is also used in abortions and has been heavily regulated since its approval in 2000 by the U.S. Food and Drug Administration. 

Mifepristone, sold under the brand name Mifeprex, effectively stops a pregnancy from developing. The drug blocks the hormone progesterone, resulting in softening of the cervix and shedding of the lining of the uterus. It is used with a second drug called misoprostol, which causes uterine cramping and bleeding and the expulsion of fetal tissue. 

Although misoprostol can be used by itself to treat miscarriages, a study published by the New England Journal of Medicine in 2018 found that treatment with mifepristone followed by misoprostol “resulted in a higher likelihood of successful management of first-trimester pregnancy loss than treatment with misoprostol alone.”

Megan Kling, who lives in Taylor, told the Milwaukee Journal Sentinel she was shocked to learn that her doctor was unable to prescribe mifepristone last year when the fetus she was carrying was found not to have a heartbeat. She needed the medication to deliver her stillborn baby. 

Despite its years of recorded safety, because mifepristone is regulated under the Risk Evaluation and Mitigation Strategy, a federal drug safety program used to determine the classification of a drug, only a health care provider who is certified under the Mifepristone REMS Program can prescribe the drug. 

Additionally, the drug can only be dispensed by or under the supervision of a certified prescriber or by a certified pharmacy. 

The only intervention Kling needed was mifepristone, but her physician was not certified to prescribe it. “And that’s what infuriates me. It’s not like I needed a specialty surgeon or a high-tech facility. I just needed a pill,” she said. 

Kling was given misoprostol alone. She told the Wisconsin Independent that when she asked if the induction of her stillborn fetus would be a similar process to the medication abortion she’d had in 2023 in Rochester, Minnesota, she was told that this one would be without mifepristone, so the chances of complications were greater. The risks included an incomplete expulsion of the uterine tissue and placenta, which could lead to infection and require further treatment such as dilation and curettage (D&C) or dilation and evacuation (D&E), to surgically remove the tissue. 

“As you can imagine, going through that entire process is traumatic enough; needing that extra surgical step afterwards just further aids in the trauma of the entire experience,” Kling said. 

Kling said she’s lucky she didn’t suffer any of the potential complications, but noted: “It’s not the best standard of care that medicine science has. Women are being given substandard care because of politics.”

While access to and distribution of mifepristone was preserved in a unanimous decision by the U.S. Supreme Court in FDA v. Alliance for Hippocratic Medicine on June 13, 2024, and the plaintiffs dropped their case, the status of the medication remains murky. 

In January, U.S. District Court Judge Matthew Kacsmaryk of Amarillo, Texas, ruled that the Republican attorneys general of Idaho, Missouri, and Kansas could proceed with their suit against the FDA to rescind the approval of the drug or, failing that, to restrict access to it. 

In February, during a hearing on his nomination to lead the Department of Health and Human Services, Robert F. Kennedy Jr. said that President Donald Trump had asked him to study the safety of mifepristone. 

“He has not yet taken a stand on how to regulate it,” Kennedy said during the hearing of the Senate Committee on Finance. “Whatever he does, I will implement those policies.”