Mifepristone Under Fire

An anti-abortion group is suing the FDA to revoke approval of Mifepristone, a key component of medical abortion.

Why it matters: Legal analysts are concerned that the extremist judge hearing the case will ban Mifepristone across the entire country as early as tomorrow (2/24/23).

• Mifepristone, combined with another medicine misoprostol, forms the safest and most effective regimen for medical abortion and the treatment of miscarriage.

What they’re saying: The plaintiffs are claiming several ideological points that don’t make legal or medical sense.

• They claim that the FDA should never have approved mifepristone, because pregnancy is not a “disease” or “illness” and therefore mifepristone has no therapeutic benefit.
• They claim that the medicine is unsafe and puts “women and girls” at a higher risk for adverse effects, including an increased risk of medical illness.

Reality check: Mifepristone has been used in the US for over 20 years, and has a better safety record than colonoscopy, wisdom tooth extraction, and Viagra.

• Serious side effects occur in <1% of cases.
• Major adverse events–serious infection, significant blood loss, or hospitalization–occur in <0.3% of cases.

Zoom In Legally: Judge Matthew Kacsmaryk is a Christian extremist who used to work for a law firm trying to end the separation of church and state.

• The plaintiffs chose his jurisdiction out of the entire country because they wanted this judge to hear the case.
• If Kacsmaryk’s decision is appealed, the extremely conservative Fifth Circuit Court of Appeals will hear the case. A second appeal would take it to the Supreme Court if they choose to hear it.

The Big Picture: Anti-abortion groups are bolder after Dobbs. They’re legally attacking abortion everywhere, because there are enough extreme judges and politicians that they think they can win.

The Bottom Line: If Mifepristone is removed from the market, people will still be able to get medical abortions, but they’ll have to use misoprostol-only regimens–which are less successful, have more side effects, and more complications.

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Go Deeper…

• Anti-abortion group sues FDA to challenge approval of abortion pills

  Axios | Oriana Gonzalez | November 18, 2022

  This article from Axios provides a good summary of what the Alliance of Hippocratic Medicine v FDA case says, including the basis that the plaintiffs are using to build their case, and what its potential effects might be.

• Alliance for Hippocratic Medicine v. FDA Court Case – NARAL Pro-Choice America

  NARAL Pro-Choice America | February 7, 2023

  What is the court case currently threatening medication abortion in the US and what could its effects be?

• Questions and Answers on Mifepristone for Medical Termination of Pregnancy Through Ten Weeks Gestation

  U.S. Food and Drug Administration | January 4, 2023

  This page is a summary of the FDA’s current position on mifepristone, broken down into FAQs. This includes uses, side effects, and restrictions.

• The Public Health Implications of the FDA Update to the Medication Abortion Label

  Guttmacher Institute | June 30, 2016

  This article from the Guttmacher Institute provides a summary of the update that the FDA gave to their approval of mifepristone in 2016 after its original approval in 2000. The article includes information about the safety profile of mifepristone and its updates uses.

• Off-label indications for mifepristone in gynecology and obstetrics – PubMed

  PubMed | Ilana G Dzuba, Daniel Grossman, Courtney A Schreiber | September 1, 2015

  This article describes the uses of mifepristone, many of which are officially off-label and all of which would be effected by a potential ban.