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TO: Interested Parties

FROM: Planned Parenthood Federation of America, American Civil Liberties Union

RE: What the mifepristone case before the Supreme Court really means

DATE: Friday, April 21, 2023

As the Supreme Court continues to consider the mifepristone case, it is important to be clear about what is at stake if the lower courts’ rulings are allowed to stand. 

But much of the coverage of what is happening is missing the forest for the trees. 

The Department of Justice and Danco briefs make it clear: The threat to mifepristone access nationwide is incredibly grave if Judge Kacsmaryk’s ruling, as modified by the Fifth Circuit, takes effect. The Fifth Circuit did not forge a compromise or middle ground: its order is still extreme, and will have catastrophic consequences on access to mifepristone across the country.

As the DOJ brief says: “Absent a stay, the lower courts’ unprecedented nationwide orders would scramble the regulatory regime governing a drug that FDA determined was safe and effective under the approved conditions and that has been used by more than five million American women over the last two decades. Every extant package of Mifeprex would instantly become misbranded and could not be lawfully introduced into interstate commerce.” 

What does that mean? According to DOJ, the brand name of mifepristone (that’s Mifeprex) would be mislabeled or misbranded, meaning that the manufacturer could not send the medication to providers until it comes into compliance which could take months.

But that’s not all. Since the generic version of mifepristone, which is manufactured by GenBioPro and accounts for about ⅔ of the market, was approved in 2019, as DOJ writes: “The generic version of the drug, which accounts for most of the market, would cease to be approved altogether.”

That’s right: According to DOJ, Danco, and GenBioPro, both the generic and name brand mifepristone could become unavailable if the lower courts’ rulings go into effect.

As FDA and Danco have explained, the lower courts’ orders staying the 2016 and all later FDA actions means that Danco may not be able to distribute Mifeprex without risking civil and criminal penalties because “all extant doses of mifepristone” become immediately misbranded and not marketable until FDA and Danco “sort through the current uncertainty and take steps to bring the drug’s labeling and other conditions into compliance with the new legal regime the lower court has abruptly imposed.”

These lower courts decisions aren’t taking us back to 2016 — they’re seeking to make medication abortion inaccessible nationwide, while undermining the public health authority of the FDA.