All US Mifepristone Moves on Hold for now

24.04.2023 - All immediate challenges to the status of abortifacient mifepristone on the US market are on ice for the near future after the Supreme Court on Apr. 21 — without considering the merits of the case — approved a Justice Department request to put temporarily suspend recent rulings by a federal district court and an appeals court.

The legal battle over whether the drug’s use should be banned or restricted and whether the US Food and Drug Administration (FDA) improperly approved it 23 years ago will continue. The next hearing is scheduled for May 17, when the 5th Circuit Court in New  Orleans revisits the case and rules on its substance.

Much is riding on the final decision, which is expected to come from the Supreme Court, and could lead to a landmark decision on the way the FDA approves drugs.

In the first legal skirmish on Apr. 7, Texas district court judge Matthew Kacsmaryk, hearing a complaint brought by anti-abortion groups, issued a preliminary injunction that threatened to revoke the FDA’s year-2000 approval along with several of its updates, if the federal government did not appeal within a week.

The Biden administration’s prompt appeal against the injunction, joined by New York-based Danco Laboratories, which sells the drug under the brand name Mifeprex, came promptly and coincided with a New Orleans-based federal appeal court’s decision to limit mail order sales and vacate updated portions of the original approval.

In the weeks or months to come, the US courts system will have a number of additional cases to deal with, including a lawsuit by GenBioPro — which makes a generic version — that would ban the FDA from pulling the drug from the market without going through a formal process that gives the company a chance to be heard.

Both the district and appeals courts will have the chance to rule on the merits of the case — rather than the urgency of removing mifepristone from the market — before it finally lands on the Supreme Court’s doorstep.

Anti-abortion groups could be expected to try to present evidence that in their view the FDA’s approval process was flawed and also raise questions about the drug's safety record.

In a dissent, two of the nine Supreme Court justices voting on whether to suspend mifepristone’s marketing approval including Samuel Alito, whose prerogative it was to respond to the appeals judgment, reportedly indicated that they would have preferred to let the ban stand. 

Alito said the stay would not remove mifepristone from the market but simply restore “the circumstances that existed” from the time it was approved in 2000 to 2016 when the FDA passed new regulations to ease access.

Since the Texas ruling, several Democratic state governments have said they are securing supplies of the abortifacient to distribute if it is banned. Canadian officials have suggested that the country’s health system could make mifepristone available to Americans, while acknowledging that the country doesn’t have enough to widely share.

Author: Dede Williams, Freelance Journalist