Status of Mifepristone

The recent Federal court rulings on the status of mifepristone may leave pharmacists wondering where they stand if they
dispense mifepristone. The answer has been changing rapidly and may continue to do so. The answer may also depend on
where the pharmacist practices.
On April 7, 2023, Judge Matthew Kacsmaryk of the United States District Court for the Northern District of Texas issued a ruling
that stayed the Food and Drug Administration’s (FDA) September 28, 2000 approval of mifepristone. The effect of this ruling
would make mifepristone an unapproved drug in the United States. The judge also stayed the effective date of his ruling for
seven days.
On the same day, Judge Thomas Rice of the United States District Court for the Eastern District of Washington issued a
preliminary injunction that prohibited the FDA from taking any action that would make mifepristone less available. This
injunction essentially negated the Texas order, but only in the 17 states and the District of Columbia which are parties in an
ongoing case before Judge Rice.
The Justice Department appealed the Texas ruling to the Fifth Circuit Court of Appeals, who issued their ruling on April 12,
2023. The appellate court’s ruling stayed the implementation of the Texas order as far as negating the FDA’s approval of
mifepristone. Their rationale was the Statute of Limitations would likely prevent the plaintiff from prevailing on the drug
approval issue. However, the Fifth Circuit went further and put the FDA’s labeling changes for mifepristone that have been
enacted since 2016 on hold also. These changes included the time period in the pregnancy in which mifepristone can be used
and its availability by mail.
Judge Rice in Eastern Washington issued an order on April 13, 2023 reiterating his previous order from April 7 and pointing out
it was not changed by the Fifth Circuit’s ruling. At this point in time, a pharmacist’s legal actions would be dictated by location.
However, the FDA was left with two contradictory rulings making it impossible for the agency to comply with both. Conflicting
rulings in the Federal court system usually lead to a definitive case before the United States Supreme Court in order to resolve
the conflict.
The Justice Department asked the Supreme Court for an administrative stay of the Fifth Circuit ruling. The stay would give the
Court time to consider the cases while leaving the status of mifepristone as if the Texas ruling had not been issued. Justice
Samuel Alito issued his administrative stay on April 15. However, Justice Alito’s stay expires at the end of the day on
Wednesday April 19.
Between now and April 19, the status of mifepristone’s approval by the FDA, and its later labeling changes, remain unchanged
by any of these rulings. Pharmacists may continue to dispense mifepristone according to previous state and Federal laws.
However, that status could be different on Thursday morning if the Supreme Court takes no further action. In that event,
access to mifepristone may depend on which of the two conflicting courses the FDA chooses to follow. If the FDA chooses to
treat mifepristone as if it was never approved, supply of the drug may not be available, even in the 17 states and District of
Columbia covered by Judge Rice’s order. Given the conflicting rulings, it seems unlikely that the Supreme Court will do nothing.
However, what form that action takes will be unknown until later this week. An update to this alert will be published at that
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