Update on Legal Challenges of FDA Approval of Mifepristone
April 21, 2023
Given breaking news about an order from the Supreme Court, access to mifepristone will remain available across the country while lower court cases work their way through the judicial system.
In the past two weeks, there have been a series of legal opinions that touch on the Food and Drug Administration’s (FDA’s) approval of a drug known as mifepristone which is a progesterone blocker. The drug typically is used in combination with misoprostol, a prostaglandin medication, in the care of a patient who has miscarried or is ending a pregnancy.
On Friday, April 7, 2023, a Texas federal judge issued a temporary nationwide injunction essentially preventing prior decisions of the FDA dating back to 2000 that approved mifepristone from going into effect during the pending trial of the case. That legal order immediately was appealed by the federal government and a manufacturer of the drug to the Fifth Circuit Court of Appeals. The appellate court issued an order on April 12, 2023 that concluded the Texas ruling dating back as far as 2000 was timed barred but the ruling impacting 2016 and more recent activity of FDA was permitted while the case was pending. In short, if that decision was not unchallenged, the approval of mifepristone would remain intact but the removal of specific conditions and other FDA decisions from 2016 on would technically be unenforceable, again, while the case was being tried. However, the appellate order was appealed to the Supreme Court that issued a temporary pause on the lower court orders until it had time to hear from the parties in the case. The Court issued an initial pause on April 14, 2023 and extended that pause again on April 19, 2023 until April 21, 2023. This is a lot of legal procedure.
On April 21, 2023, the Supreme Court issued an order continuing to pause the lower court orders until the appeal to the Fifth Circuit is concluded. The effect of the order is to permit access to mifepristone nationwide at least until lower court cases are completed. The opinion and order of the Supreme Court may be viewed here
Apart from the legal cases above, a separate case was brought in Washington by a list of state attorney generals including Oregon. On April 7, 2023, the judge in Washington issued an order that sought to temporarily prevent the FDA from “altering the status quo and rights as it relates to the availability of mifepristone” under a 2023 decision from FDA. That judge’s order only would be applicable to the 17 states and District of Columbia listed as plaintiffs in that case during the pending trial.
The legal status of mifepristone certainly is confusing especially for clinicians and their patients. On April 21, 2023, the Oregon Medical Board posted a notice
about authority to prescribe medications that may not be approved by the FDA. The notice provides that: “OMB licensees whose scope of practice includes prescribing for reproductive health care may continue to prescribe mifepristone for their patients despite current federal lawsuits involving the medication.”
Additional information about the drug may be tracked on this FDA
page and there is more in-depth reporting in this health policy page
hosted by the Kaiser Family Foundation.