The Supreme Court Battle Over Mifepristone: A Widely Used Abortion Drug and the FDA’s Regulatory Authority
The United States Supreme Court is set to deliberate on a contentious issue regarding the accessibility of Mifepristone, a widely utilized abortion drug. This dispute centers around the extent of the US Food and Drug Administration’s (FDA) regulatory power regarding Mifepristone, a medication that has been deemed safe and effective by the medical community.
Background: The Journey to the Supreme Court
The FDA initially approved Mifepristone in 2000; however, in subsequent years, including 2016, 2019, and 2021, the FDA implemented modifications to make the drug more accessible. These adjustments addressed matters such as dosing requirements and in-person dispensing. Additionally, they enabled the drug to be taken later in pregnancy.
However, challengers argue that during these years, the FDA did not adequately consider the safety implications of the drug when it made it more accessible. The legal skirmishes began in spring 2023 when US District Judge Matthew Kacsmaryk, an appointee of former President Donald Trump, sought to halt the FDA’s 2000 approval of Mifepristone.
The 5th US Circuit Court of Appeals, known for its conservative leanings, partially retracted this ruling by stating that it was too late for the challengers to contest the initial 2000 approval of the drug. However, they did block modifications made in 2016 and 2021.
Subsequently, the Supreme Court agreed to review an appeals court decision that restricted access to Mifepristone while declining a separate appeal by abortion foes to reconsider if the FDA’s 2000 approval of the drug was unlawful.
Understanding Mifepristone: An Overview and Its Uses
Mifepristone, also marketed under the brand names Mifeprex or Korlym and occasionally referred to as RU 486, is one of two primary drugs used in the US for medication or medical abortions. The other drug is misoprostol.
Mifepristone functions by obstructing a hormone called progesterone, which plays a vital role in sustaining a pregnancy. Progesterone aids in maintaining the inner lining of the uterus. In the absence of progesterone, the uterus expels its contents. After ingesting Mifepristone, a patient waits 24 to 48 hours to take misoprostol. This second medication assists in emptying the uterus through bleeding and muscle contractions.
Consumption of Mifepristone and misoprostol typically results in intense cramps and heavy bleeding for approximately three to five hours. Regular menstrual periods usually resume within a couple of weeks. Within 14 days of taking the medication, a patient performs a pregnancy test to determine if the abortion is complete. If it isn’t, depending on the timing, they may require further medication or, in rare cases, a surgical abortion. At a follow-up appointment, a medical professional assesses for infection.
Mifepristone can be taken immediately following the discovery of pregnancy up to 10 weeks after the first day of the last menstrual period. The FDA approved this drug, in combination with misoprostol, for abortion in 2000.
