DOJ, Drugmaker Ask SCOTUS to Move on Mifepristone

If the ruling remains in place, it could affect drug availability nationwide
By Steve Huff,  Newser Staff
Posted Apr 14, 2023 12:09 PM CDT
DOJ, Drugmaker Ask SCOTUS to Move on Mifepristone
A patient prepares to take the first of two combination pills, mifepristone, for a medication abortion.   (AP Photo/Charlie Riedel, File)

Just a day after the Justice Department announced that it disagreed with a ruling limiting abortion pill access, the Biden administration has requested that the Supreme Court block a Wednesday ruling from the 5th US Circuit Court of Appeals that prevents pregnant women from receiving the drug mifepristone by mail. NBC reports that on behalf of the FDA, Solicitor General Elizabeth Prelogar asked the Supreme Court to put a complete stop to the decision while the legal fight over the case from Texas plays out. Otherwise, the tightened rules, under which the drug could only be prescribed up to seven weeks of pregnancy, not 10, and not by mail, will kick in at 1am ET Saturday.

In court documents, Prelogar argued that the lower court orders contradict the FDA's scientific judgment and suspended the current FDA-approved conditions for using mifepristone. The FDA approved the drug more than 20 years ago. Danco Laboratories, which makes mifepristone under the brand name Mifeprex, also wants the Supreme Court to act. It notes that should the FDA be forced to implement the new restrictions, that would require new labeling that could take months to get in place. During that time, Danco wouldn't be able to distribute the drug. The AP outlines what the FDA and Danco want:

  • A temporary order that would keep the FDA regulations regarding mifepristone in place.
  • A lengthier order that would keep those regulations in place for the duration of the legal fight over the drug.
  • If that's not possible, they'd like the court to take up the issue, hear arguments, and rule by early summer. The AP notes the court "rarely acts so quickly to grant full review of cases before at least one appeals court has thoroughly examined the legal issues involved."
  • The New York Daily News reports Justice Samuel Alito has appeals from the 5th Circuit under his purview; he'll have until 1am Saturday to decide to put the ruling on hold or not.

NBC notes that the situation has been further complicated by a Washington state federal judge's decision to issue a preliminary injunction in a separate case that prevents the FDA from making any changes relating to mifepristone's availability in 17 Democrat-led states suing to keep it on the market. It’s unclear how the FDA can comply with court orders in both cases.
(More mifepristone stories.)

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