traffic_analyzer/DigitalVision V

Abortion Rights on the Line Again as SCOTUS Hears Mifepristone Case

This week, SCOTUS announced it would hear the mifepristone case and make a final ruling on access to the abortion pill.

On December 13, 2023, the Supreme Court of the United States (SCOTUS) agreed to review an August case whose appeals court decision restricted access to mifepristone, one of the two drugs used for medication abortions. The initial decision was issued on Wednesday, August 16, 2023, by the US Court of Appeals for the Fifth Circuit. To understand the critical importance of this case, it is essential to review the timeline of events that led to it.

On January 13, 2023, the Alliance for Hippocratic Medicine filed a lawsuit against the US Food and Drug Administration (FDA) to reverse the mifepristone’s approval. Despite the medication’s 23-year evidence-based approval and input from multiple healthcare professionals that highlighted the drug's favorable safety and efficacy profile, Mathew Kacsmaryk, a Trump-appointed federal judge in Texas, ruled against scientific opinion and issued a preliminary injunction that invalidated the FDA approval of mifepristone in 2000 on April 7, 2023.

Shortly after this preliminary decision, on April 14, 2023, Samuel A. Alito Jr., a SCOTUS judge, issued an order that lifted restrictions on abortion pills pending a final ruling from SCOTUS. Just one week later, on April 21, 2023, SCOTUS voted to uphold mifepristone’s approval pending ongoing cases, effectively reversing Kacsmaryk’s ruling.

Unfortunately, the debate on abortion pill access did not end there. On August 16, 2023, the US Court of Appeals for the Fifth Circuit issued a decision that restricted abortion pill access after reviewing its initial approval, the 2016 approval amendments, the 2019 generic approval, and the 2021 non-enforcement decisions.

The August ruling compromised access to comprehensive reproductive healthcare, reversing the 2021 non-enforcement decision, which lifted restrictions that required the medication to be prescribed and dispensed in person. Although the order did not reverse the drug approval, it added an additional barrier to accessing the drug.

To combat this, Danco Laboratories, mifepristone’s manufacturer, requested SCOTUS intervention in September 2023 to re-evaluate the ruling. The decision made by the Supreme Court on this case could set a precedent for the FDA’s authority moving forward.

Next Steps

Dig Deeper on Medical research and development