Mifepristone legal fight: What you need to know

How the lawsuits could affect access to the abortion drug and FDA approvals.
article cover

Robyn Beck/Getty Images

· 5 min read

The fight over abortion access continued to heat up in recent days as dueling federal court rulings from April 7 may have put into question the fate of abortion drug mifepristone.

The legal battle, which centers on the Food and Drug Administration’s approval of the medication, comes less than a year after the US Supreme Court struck down Roe v. Wade and with it the constitutional right to abortion.

The rulings in Texas and Washington could not only affect medication abortion access nationwide, but also have major repercussions for the pharmaceutical industry and drug approval process.

Healthcare Brew breaks down what you need to know about the legal fight surrounding mifepristone.

Court fight

On April 7, Judge Matthew Kacsmaryk of the US District Court for the Northern District of Texas ordered a hold on the federal government’s approval of mifepristone, a drug which has been widely used for abortions since the FDA signed off on it in 2000.

But Judge Thomas Rice of the US District Court in the Eastern District of Washington directed the federal government—in a simultaneous ruling—to not restrict access to mifepristone in at least 17 states and DC.

The conflicting rulings set the stage for additional legal proceedings (likely in the Supreme Court) and put the fate of mifepristone into question.

President Joe Biden said Friday that his administration will fight to protect reproductive freedom, arguing that the Texas judge’s ruling “undermines the FDA’s ability to approve safe and effective medications.”

Department of Justice officials filed an appeal of the Texas judge’s ruling with the Fifth Circuit Court of Appeals. They requested a decision by noon on April 13.

Danco Laboratories, the manufacturer of mifepristone drug Mifeprex, is also appealing the ruling.

Danco spokesperson Abby Long told Healthcare Brew that the company is “continuing to supply [its] customers, business as usual, and will continue to do so as long as is legally feasible.”

Industry response

Following Friday’s rulings, more than 500 drug company executives, biopharma industry professionals, and others signed a letter to “unequivocally support the continued authority of the FDA to regulate new medicines.”

The Texas judge’s decision “set a precedent for diminishing FDA’s authority over drug approvals, and in so doing, creates uncertainty for the entire biopharma industry,” according to the letter. “We call for the reversal of this decision to disregard science, and the appropriate restitution of the mandate for the safety and efficacy of medicines for all with the FDA.”

Navigate the healthcare industry

Healthcare Brew covers pharmaceutical developments, health startups, the latest tech, and how it impacts hospitals and providers to keep administrators and providers informed.

A coalition of attorneys general representing more than two dozen states has also called on the Fifth Circuit to halt the Texas judge’s ruling from taking effect. And some states, like California, New York, and Massachusetts, are stockpiling the drug.

Why it matters

If mifepristone loses federal approval, that leaves just one FDA-approved drug option—misoprostol—for people seeking medication abortions in the US (including in states with strong abortion protections and access).

In the US, misoprostol is typically used in conjunction with mifepristone to end pregnancies up to 10 weeks. Misoprostol-only regimens can also be used for abortion, but that practice is more common outside the US. Still, healthcare experts like Jenny Higgins, a professor of obstetrics and gynecology at the University of Wisconsin Madison, argue that the misoprostol-only regimen is “still extremely safe, but it’s not as good or effective.”

Medication abortions have grown in popularity since the FDA’s approval of mifepristone. They accounted for more than half (53%) of facility-based abortions in the US in 2020—or 492,210 out of a total of 930,160—according to a 2022 Guttmacher Institute analysis. That’s up from 39% in 2017 and 6% in 2001.

But the US saw ~32,000 fewer abortions in the six months after the Supreme Court’s June 2022 ruling that overturned Roe, according to the Society of Family Planning’s #WeCount report released Tuesday. The report, which looked at abortion data from July through December 2022, attributed the decline largely to state bans on the procedure.

Reproductive health advocates like National Institute for Reproductive Health (NIRH) President Andrea Miller argue that while misoprostol-only abortions are safe (and have been endorsed by the World Health Organization), the medication may not be the best option for people who must travel to another state for an abortion.

“Misoprostol starts to work sooner than mifepristone and the process can last longer, so you may end up needing to stay longer if you’ve gone to another state,” Miller told Healthcare Brew. “That change in the impact could make medication abortion utilizing misoprostol harder for people…This will be another very significant barrier because of the added logistics involved in accessing alternative methods.”

Navigate the healthcare industry

Healthcare Brew covers pharmaceutical developments, health startups, the latest tech, and how it impacts hospitals and providers to keep administrators and providers informed.