Abortion Drug Maker Asks Supreme Court to Toss Appellate Ruling

WASHINGTON — Danco Laboratories, maker of the Mifeprex® abortion pill, asked the Supreme Court on Friday to overturn a ruling by the 5th U.S. Circuit Court of Appeals that would dramatically limit the availability of the drug.

In August the conservative 5th Circuit ruled Mifeprex® and its generic counterpart, mifepristone, can remain on the market where abortion is legal, but it blocked steps the Food and Drug Administration has taken in recent years to make the drug more accessible.

According to the court, the FDA acted improperly in several respects: when it said mifepristone can be used up to 10 weeks of pregnancy rather than seven; when it allowed the medication to be mailed to patients; and finally, when it permitted providers other than physicians to prescribe the drug. 

However, that decision will remain on hold until the Supreme Court decides whether to take up the case in the term that begins in October.

In its petition, Danco Laboratories said the case presents a serious question: whether courts can disregard constitutional and statutory limits on judicial review of agency action to overrule agency decisions that they dislike. 

The drug manufacturer is asking the court to grant review of both the determination that doctors who do not prescribe or want to prescribe Mifeprex® have standing and the determination that FDA acted unreasonably in approving the changes in 2016 and 2021 despite the extensive study and other data supporting those decisions. 

The case marks the highest stakes legal battle on abortion since the Supreme Court overturned Roe v. Wade last year. 

The Justice Department is also expected to file a separate appeal with the Supreme Court.

In a press release announcing its filing, Danco Laboratories said Mifeprex® is the most commonly used medication for termination of early pregnancy.  

“Over 5 million women have used Mifeprex® in the United States since its approval for the termination of early pregnancy in 2000,” it said, adding that the pill is about 97% effective in terminating early pregnancy.

It also said about 3% of women who take the drug will require surgical intervention for ongoing pregnancy, heavy bleeding, incomplete expulsion “or other reasons such as patient request.”

“Danco remains confident in the safety and effectiveness of Mifeprex® under the 2023 REMS that currently governs its use,” the company said in a written statement. “The FDA actions at issue were well supported by extensive safety and effectiveness data from clinical trials and decades worth of real-world experience in millions of patients.”

In the filing, Danco attorney Jessica Ellsworth wrote that the 5th Circuit’s decision “raises questions about whether a single federal court can limit abortion access in the states that protect it.”

She went on to say the decision “destabilizes the pharmaceutical and biotechnology industries by questioning when scientific studies — accepted by FDA — are sufficient to support conditions of use.” 

If the high court takes up the case, oral arguments would likely occur sometime in early 2024, with a decision coming at the end of the term in June.

Dan can be reached at [email protected] and @DanMcCue