Mifepristone Future Uncertain, Pushback is United and Swift

On Friday night, April 7th, District Judge Matthew Kacsmaryk of Amarillo, Texas ruled to suspend FDA approval of the abortion drug mifepristone (Mifeprex), making the drug's future accessibility uncertain in a move that many experts believe challenges the foundations of the FDA’s entire drug approval process.

Three weeks ago, on March 15th, Kacsmaryk listened to arguments¹ from anti-abortion groups who argued in favor of this FDA override. Now, after weeks of speculation, Kacsmaryk has sided with those groups, and made official a decision that many expected, and many others feared.

This case originated when anti-abortion groups began arguing that the FDA was not vigilant enough in its testing and approval of mifepristone. The Alliance Defending Freedom, a hyper-religious anti-abortion group, was leading the charge against mifepristone. It claimed that the FDA was “running roughshod over the laws and regulations that govern the agency and, more importantly, protect the public from harmful drugs," in its approval of mifepristone. The group’s website is full of unfounded claims, including headlines like “FDA’s Reckless Actions Enable Sex Trafficking.”

The FDA stood behind² its 2000 approval of mifepristone during the hearing and continues to stand behind the drug in the wake of Kacsmaryk’s ruling, saying in a statement that “The FDA has appealed this decision. FDA approved mifepristone more than 20 years ago based on a comprehensive review of the scientific evidence available and determined that it was safe and effective for its indicated use—medical termination of early pregnancy."

In Washington, Judge Thomas Rice argued that mifepristone is safe and effective, and said that a nationwide ban on mifepristone would be "inappropriate," in an attempt to keep the abortion pill on shelves in 17 states.

Days earlier, on April 4, Washington governor Jay Inslee took preemptive action in anticipation of this ruling from Judge Kacsmaryk by ordering the Washington Department of Corrections to buy 30,000 doses of mifepristone for patients in the state—nearly a 3-year supply, according to Oregon Public Broadcasting.³

The American College of Obstetricians and Gynecologists is also fighting back against Kacsmaryk’s ruling, saying that the ruling is based on an idea that “Deliberately ignores decades of evidence-based scientific data and eschews clinically appropriate language about mifepristone.”

As our partner site Drug Topics reported last month, mifepristone is taken in a regimen with the drug misoprostol, which can serve as an abortion pill on its own. Misoprostol was not part of this hearing, so expect abortion clinics and health care providers to supply misoprostol on its own in the future.

“Misoprostol alone is effective and safe and is a reasonable option for women seeking abortion in the first trimester,” said researchers of a 2019 study published by the National Library of Medicine.⁴ However, when misoprostol is taken in a regimen with mifepristone, the efficacy is nearly 100%. When misoprostol is taken by itself, the efficacy drops to anywhere from about 80% to 95%, a relatively steep drop-off. Hence, mifepristone is a supremely important medication for individuals attempting to carry out an abortion via pill—which is now over half of all abortions in the United States.

References

1. US District Judge Hearing Arguments to Potentially Halt Distribution of Abortion Pill Mifepristone. Drug Topics. March 15, 2023. https://www.drugtopics.com/view/us-district-judge-hearing-arguments-to-potentially-halt-distrib ution-of-abortion-pill-mifepristone

2. FDA says it has appealed judge's ruling in Texas and stands by mifepristone approval. CNN Politics. April 7, 2023. Accessed April 8, 2023. https://www.cnn.com/politics/live-news/texas-abortion-pill-mifepristone-ruling/index.html

3. Dueling federal rulings leave abortion drug access in limbo, as Oregon, Washington prepare to fight back. Oregon Public Broadcasting. April 7, 2023. Accessed April 8, 2023. https://www.opb.org/article/2023/04/07/oregon-washington-access-abortion-drug-mifepristone-f ederal-ruling-texas-fda-approval/

4. Raymond EG, Harrison MS, Weaver MA. Efficacy of Misoprostol Alone for First-Trimester Medical Abortion: A Systematic Review. Obstet Gynecol. 2019 Accessed April 8, 2023. doi: 10.1097/AOG.0000000000003017. PMID: 30531568; PMCID: PMC6309472.