Update – Friday, April 21, 2023 – The U.S. Supreme Court ruled 7-2 today to stay the entire order issued by Judge Kacsmaryk of Texas. This ruling overrules the Fifth Circuit Court of Appeals’ order that partially stayed Kacsmaryk’s order. As a result, mifepristone’s status will remain unchanged until the Fifth Circuit hears the case and makes a ruling on the merits. The hearing is expected to be held in May. Pharmacists may continue to dispense mifepristone according to previous state and Federal laws until a final ruling on the merits is issued.
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, which issued its 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 which 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, a 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 anything. However, what form that action takes will be unknown until later this week. An update to this alert will be published at that time.
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