The Biden administration, along with drug manufacturer Danco, have asked the Supreme Court to review a federal appeals court decision that could significantly limit access to medication abortions. Notably, these make up over half of all abortions in the United States. This comes as a response to an order from the U.S. Court of Appeals for the 5th Circuit’s ruling on August 16, which was temporarily suspended to allow the drug to remain widely accessible until the conflict is conclusively resolved.
The drug in question, mifepristone, is part of a two-drug protocol used to terminate pregnancies in the early stages. Since its approval by the FDA in 2000, several changes to its usage conditions have been made, including extending its usage period up to the 10th week of pregnancy, enabling non-physician healthcare providers to prescribe it and making it available for telehealth appointments and deliveries through mail.
However, the FDA’s approval of mifepristone was met with opposition from an assembly of doctors and medical groups who have concerns about the drug’s safety. The ruling by U.S. District Judge Matthew Kacsmaryk echoed these concerns, leading to the suspension of both the FDA’s approval of the drug and the subsequent changes made to its usage regulations.
This approval was also the subject of a challenging 62-page decision by the 5th Circuit. The court ruled that mifepristone’s initial approval from 2000 couldn’t be contested but agreed with Judge Kacsmaryk’s rulings that put a hold on the FDA’s changes to accessing the drug implemented in 2016 and 2021.
The Biden administration and Danco’s appeal to the Supreme Court mentions significant implications should the 5th Circuit’s ruling stand, as it would have a damaging effect on women seeking lawful abortions and the healthcare system that heavily relies on the drug’s availability under current usage conditions. They also pointed out that this would be the first instance of a court restricting access to an FDA-regulated drug due to disagreement with the FDA’s judgment about usage conditions.
Danco further emphasized that the central question in this case is whether courts can neglect constitutional and statutory limits on judicial reviews of executive actions to overturn agency decisions they dislike. The implications of this case for the pharmaceutical industry are considerable, as it would allow the judiciary to undermine the FDA’s scientific evaluations, thus causing significant instability.
The petitioners opposing the administration and Danco have thirty days to reply to the review petitions filed last Friday. This period might be extended for another thirty days if required. The Supreme Court is expected to announce whether or not it will hear the case in the coming fall.