April 24, 2023

How an abortion pill ruling could threaten the FDA's regulatory authority

Two contradictory court rulings are raising questions not only about the future of the abortion pill mifepristone, but the federal government's authority to approve and regulate drugs in general.

Mifepristone is widely used across the U.S. to end pregnancy in the first 10 weeks of gestation and help manage miscarriages. The Food and Drug Administration (FDA) first approved it in 2000, after it evaluated data and concluded the drug's health benefits outweigh its risks.

More than two decades later, a federal judge in Texas refuted the FDA's approval, issuing an injunction that would suspend its approval nationwide. That pause is set to take effect on Friday, though the Justice Department has appealed to block it.

In Washington state on Friday, a different federal judge issued a separate ruling that prohibits the FDA from pulling the drug from the market.

Uncertain about the future of mifepristone access, several states began stockpiling doses of the drug, major pharmaceutical companies expressed support for the FDA, and some Democrats and at least one Republican lawmaker urged the Biden administration to ignore the Texas ruling (a suggestion the White House dismissed as a potentially "dangerous precedent").

Holly Fernandez Lynch, an assistant professor of medical ethics and law at the University of Pennsylvania, calls the Texas ruling "truly an unprecedented decision."

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