Abortion Pill Maker Danco Weighs Adding Miscarriage Use to Label

The maker of Mifeprex, the brand version of abortion pill mifepristone, indicated it’s open to adding miscarriage as a use on the label—if it can still market the drug after a Texas judge blocked it.

Danco Laboratories LLC would not be able to change the label if Mifeprex were suspended or withdrawn from the market, a company spokesperson said.

“We believe other indications, including miscarriage management, are important for patients in the US. Although we have limited options now, we are considering continued activity in this area,” Abby Long, spokesperson for Danco, wrote in an email.

Mifepristone is widely prescribed off label in a regimen with misoprostol to manage miscarriages. Adding this use to the drug’s official label could help ensure providers are able to prescribe the drug in the face of state and nationwide efforts to restrict abortion access.

Danco’s statement marks the closest the company has come to indicating it may take steps to change the label.

Senate Democrats have pressured the company to add miscarriage management to the drug’s label in the face of state laws limiting access. The FDA rejected a citizen petition, saying the company itself must request a label change, and Long said in February the company didn’t have any plans to pursue one.

The statement to Bloomberg Law follows an order issued April 7 to suspend the Food and Drug Administration’s decades-old approval of mifepristone by US District Judge Matthew Kacsmaryk in Texas, who was appointed by President Donald Trump.

Danco said Monday it is seeking a stay on the order in the Fifth Circuit. The company previously intervened as a defendant in the case.

If the Fifth Circuit does not grant a stay, it’s likely that either Danco and or the US will elevate the request to the Supreme Court, Jessica Ellsworth, a partner with Hogan Lovells and the lead counsel for Danco in this case, said in a press call. The call was organized by the American College of Obstetricians and Gynecologists.

“Without a stay, the injunction is certain to cause irreparable harm to women who will lose access to the medication abortion regimen that is the standard of care,” Ellsworth said.

She said it would also cause harm to Danco whose only product is Mifeprex, as a well as “harm to the pharmaceutical and biotechnology industries, which rely on FDA approvals when making decisions about investing and innovating in future drugs, and harm to the separation of powers that undergirds judicial and regulatory action.”

When asked about requesting miscarriage management be added to the label, Ellsworth told reporters there were no updates from Danco on that process at this time.

Kacsmaryk’s decision came shortly before Judge Thomas O. Rice of the US District Court for the Eastern District of Washington ruled the FDA can’t change anything about the way it regulates the drug—essentially setting up the agency for two seemingly contradictory rulings within a matter of hours.

Mifepristone is widely used to terminate an early pregnancy up to 10 weeks after gestation. But the drug has also been used off-label to help with miscarriages, which happen in up to 30% of pregnancies in the US.

A 2018 study in the New England Journal of Medicine a combination of mifepristone and misoprostol works better to manage pregnancy loss in the first trimester than using misopristol alone.

“We previously used a misoprostol-only regimen in order to medically manage miscarriage, and there is data to show that the combination regimen of mifepristone and misoprostol increases the safety and effectiveness of medication management for miscarriage,” Jennifer Villavicencio, ACOG’s lead for equity transformation, said in Monday’s call.