FDA Awaits Mifepristone Ruling

Ever since Roe v. Wade was overturned by the Supreme Court in June of 2022, some states have enacted restrictive abortion measures. Oklahoma has a total abortion ban, and in Florida it is restricted to before 15 weeks. On March 17th, Wyoming passed a law that banned both the prescription and use of abortion medication, punishable by jail time or a $9,000 fine.

On March 15th, the U.S. District Court of Northern Texas heard a lawsuit from the Alliance of Hippocratic Medicine, an activist group of physicians that are against abortion. The suit calls for a ban on mifepristone, an abortion pill that ends pregnancy up to 10 weeks, as described by the Food and Drug Administration (FDA). According to NBC News, the group alleged that the FDA did not adequately evaluate mifepristone before its approval in 2000 and argued that the agency should not have made the medication accessible by mail (instead of only in person) during the pandemic.

Judge Matthew J. Kacsmyrck (he/him), a district court judge appointed by former President Donald Trump (he/him) in 2019, is presiding over the case. The Alliance has filed a motion for a preliminary injunction, and if Kacsmyrck rules in their favor, mifepristone could be temporarily removed from the market. Furthermore, if he also rules in their favor for the lawsuit, FDA approval will be revoked and mifepristone will be illegal in every state. The FDA could begin the approval process again, but that typically takes several years.

If Judge Kacsmyryck should rule to withdraw the mifepristone pill immediately, the Biden administration has stated it will appeal the decision. Lawyers from the Department of Justice argued on behalf of the FDA. Rachel Rebouche (she/her), a drug law expert, told CNBC that if Kacsmyrck ruled to ban the drug, the FDA could argue that the court does not have the authority to strike down mifepristone’s approval, based on federal statute.

Kacsmyrck could issue a decision at any point in the coming weeks. Another lawsuit, coming out of federal district court in Washington, was brought by Democratic attorneys general arguing to expand mifepristone access in 17 states. The judge, Thomas Rice (he/him), is expected to rule in favor. Two conflicting rulings on mifepristone could ultimately result in a decision from the Supreme Court.

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