US district judge hearing arguments to potentially halt distribution of abortion pill mifepristone

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In 2000, the FDA approved¹ the drug Mifeprex (mifepristone) to medically terminate a pregnancy through ten weeks gestation. In 2019, the generic version of Mifeprex—Mifepristone Tablets—was also approved by the FDA.

But as of March 2023, US District Judge Matthew Kacsmaryk of Amarillo, Texas, could decide to halt distribution of mifepristone throughout the country in a court case that experts believe recklessly disregards the FDA’s entire drug approval system. An overturn “could be catastrophic for public health,” Harvard Medical School professor Aaron S. Kesselheim told the Washington Post.² “An adverse ruling would be concerning for the FDA’s authority and for the ability of people to receive consistent care for their conditions.”

On March 15, Kacsmaryk heard arguments to overturn the FDA’s approval of mifepristone more than 2 decades later. In 2000, the FDA granted mifepristone accelerated approval because it was deemed to be treating “serious or life-threatening illnesses.”

Now, the anti-abortion group Alliance Defending Freedom is leading the fight against mifepristone, claiming the FDA made a mistake in its original ruling, and urging Kacsmaryk to reverse mifepristone’s approval. "The FDA took these actions by running roughshod over the laws and regulations that govern the agency and, more importantly, protect the public from harmful drugs," it claims in reference to mifepristone’s approval.

The group does not shy away from being publicly anti-abortion, as its website contains statements such as “Babies deserve a chance at life” and “Women deserve better than abortion.”

While there are no specific numbers on how many people use mifepristone tablets, a recent survey from the Guttmacher Institute³ found that over 50% of abortions in the United States are done via pill—hence, this ruling will impact a massive swath of people, and could limit nationwide abortion access even further. Even states that attempt to protect reproductive rights are not safe from this ruling, as a ruling against mifepristone would likely make the drug unavailable everywhere.

However, mifepristone is taken in a regimen with the drug misoprostol, which can serve as an abortion pill on its own. Misoprostol is not part of the hearing and, according to CBS News, “In anticipation of an order from Kacsmaryk blocking access to mifepristone, abortion providers are preparing to offer misoprostol-only abortions.”⁴

Kacsmaryk himself cannot “ban” mifepristone or “stop it from being sold,” says David S. Cohen, a law professor at Drexel University, and drugs that don’t have FDA approval can sometimes still be sold and marketed. According to Cohen, “how the FDA and drug companies react is probably even more important” than Kacsmaryk’s ruling.

Kacsmaryk was long part of the First Liberty Institute, a conservative, hyper-religious group that staunchly condemns abortion. Kacsmaryk was appointed to the federal bench by former President Donald Trump, a decision that received backlash from organizations such as Alliance for Justice, a progressive judicial advocacy group.

Both sides were given 2 hours to make their arguments on the morning of March 15. A decision is expected as early as today.

References

1. Information about mifepristone for medical termination of pregnancy through ten weeks gestation. Food & Drug Administration. January 24, 2023. Accessed March 15, 2023. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/information-about-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation

2. Abortion pill fight may have broader implications for FDA drug approval. The Washington Post. March 15, 2023. Accessed March 15, 2023. https://www.washingtonpost.com/health/2023/03/15/abortion-pill-fda/

3. Jones R, Nash E, Cross L, et al. Medical Abortions now account for more than half of all US abortions. Guttmacher Institute. February 24, 2023. Accessed March 15, 2023. https://www.guttmacher.org/article/2022/02/medication-abortion-now-accounts-more-half-all-us-abortions

4. Abortion pill challenge heads before federal judge in Texas. CBS News. March 15, 2023. Accessed March 15, 2023. https://www.cbsnews.com/news/abortion-pill-lawsuit-texas-judge-matthew-kacsmaryk-mifepristone-fda/

This article was initially published by our sister publication Drug Topics.