FDA launches long-awaited safety study of mifepristone, the abortion pill

The Food and Drug Administration (FDA) has announced it is finally launching its long-promised safety review of the drug mifepristone, commonly known as the abortion pill.

Key Takeaways:

• The FDA has been promising to conduct a study on the safety of mifepristone for months, and has been accused by some of intentionally delaying the review.

• A senior FDA official confirmed that the review is now taking place.

• The state of Louisiana sued the FDA over weakened safety standards regarding mifepristone, and the FDA was ordered to submit a status report on its safety review by October 7th.

The Details:

A senior FDA official has confirmed that the promised safety review of mifepristone will be moving forward, and will likely take six months to complete. The review was announced last year, but it appears no action had yet been taken to begin the process, and the FDA and its former commissioner, Marty Makary, had been accused of intentionally delaying the study. A Bloomberg report claimed (emphasis added):

Makary and Health and Human Services Secretary Robert F. Kennedy Jr. have told lawmakers and state attorneys general for months that they are actively conducting a review of mifepristone. But behind the scenes, Makary has told agency officials to delay the safety review, people familiar with the discussions said...

... Pushing the closely watched abortion pill study beyond next year’s midterms has the potential to help minimize the role of abortion in the upcoming elections, in which some Republicans are facing tough battles to hold onto their seats. Abortion restrictions popular with the right-wing base don’t necessarily poll well with all voters. A 2024 Pew survey found majorities of moderate or liberal Republicans say abortion should be legal in all or most cases.

The FDA announced the review after a large insurance claims analysis from the Ethics and Public Policy Center (EPPC) found that nearly 11% of women (10.93%) experience complications, like sepsis, infection, hemorrhaging, or other serious or life-threatening adverse events, meaning one in 10 women likely experience at least one serious complication after taking mifepristone. This rate was 22 times higher than the “less than 0.5 percent” serious adverse events rate reported by the FDA on the mifepristone label.

Despite this, the FDA approved a second generic abortion pill from Evita Solutions LLC in September.

The Backstory:

In 2023, the Food and Drug Administration (FDA) weakened its safety regulations (REMS) on the abortion drug mifepristone (200mg)/Mifeprex, allowing it to be dispensed by mail and through retail pharmacies. In October of 2025, the State of Louisiana filed a lawsuit seeking to reinstate the previous safeguards.

The FDA responded by asking the courts to pause the lawsuit as it reviewed the safety regulations of mifepristone, which was approved on April 6, pending the FDA's safety review results. Louisiana then appealed that decision on April 17.

The Fifth Circuit Court of Appeals ruled in Louisiana's favor, pausing mail-order dispensing of the abortion pill and ruling that the "FDA's justifications for remotely dispensing mifepristone were based on flawed or nonexistent data," and that the change in safety protocols "resulted in numerous illegal abortions in Louisiana and in Louisiana paying thousands in Medicaid bills for women harmed by mifepristone."

That decision was overturned by the Supreme Court, however, allowing mail-order abortions to continue as the lawsuit makes its way through the courts.

The Bottom Line:

There are serious risks associated with taking mifepristone, and ultimately, it is being used to end the lives of innocent children in the womb. Removing safety regulations and allowing the drug to be shipped in the mail increases the risks to women and allows more children to die.