The Supreme Court has recently agreed to hear a significant case concerning the Biden administration’s regulatory actions regarding mifepristone, a pill commonly used for medication abortions.
This decision has garnered immense attention as it could potentially impact the availability and accessibility of this drug, raising concerns among proponents and opponents alike.
Let’s delve into the details of this case and its implications for women’s reproductive healthcare.
The Regulatory Changes
In 2016, prescription rules for mifepristone were relaxed, and further changes were made in 2021 to allow prescriptions to be sent through mail, making it more convenient for patients.
However, opponents argue that these regulatory changes compromise women’s safety.
A lower court previously blocked the sale of mifepristone, citing concerns about the drug’s approval process. However, in April, the Supreme Court overturned this order, allowing sales to continue.
This decision has fueled a contentious legal battle with far-reaching consequences.
The Medication Abortion Process
Mifepristone plays a crucial role in medication abortions. It works by blocking progesterone, a hormone, while misoprostol induces contractions. The current litigation primarily revolves around mifepristone’s regulation, with misoprostol not being a point of contention.
The Supreme Court’s decision to hear this case makes it the most important abortion-related matter since the June 2022 ruling in Dobbs v. Jackson Women’s Health Organization, which overturned Roe v. Wade and shifted the regulation of abortion back to the states. T
The recent decision came through unsigned orders, with no dissents, leaving some questions unanswered.
The Supreme Court agreed to hear two cases: Food and Drug Administration (FDA) v. Alliance for Hippocratic Medicine (AHM) and Danco Laboratories LLC v. AHM. However, they declined another petition in AHM v. FDA. Danco Laboratories is the manufacturer of the abortion pill known as Mifeprex or RU-486.
The Alliance for Hippocratic Medicine (AHM) is dedicated to upholding and promoting the fundamental principles of Hippocratic medicine, which include protecting vulnerable individuals at both the beginning and end of life, ensuring the patient’s ultimate good with compassion and moral integrity, and providing healthcare based on the highest standards of excellence rooted in medical science.
FDA Approval Controversy
In April, a federal district judge determined that the FDA had wrongfully approved mifepristone for public use in 2000 and had obstructed opponents’ efforts for years. The judge also found fault in the FDA’s decision to lift restrictions related to accessing the drug in 2016 and 2021.
In 2016, the FDA modified the drug’s label, extending its use cutoff from 49 to 70 days of gestation, permitting non-doctors to prescribe it with just one in-person visit, and eliminating the requirement for prescribers to report nonfatal adverse events related to the drug.
In 2019, the FDA approved a generic version of the drug, and in 2021, it allowed patients to receive the drug via mail.
Legal Battle Escalation
The U.S. Department of Justice (DOJ) appealed the district judge’s decision, but the U.S. Court of Appeals for the 5th Circuit refused to block most of the order. The 5th Circuit found the FDA’s actions in 2016 and 2021 potentially unlawful, prompting the FDA and Danco to seek Supreme Court review.
On August 16, the 5th Circuit upheld restrictions on the abortion pill imposed by the district judge, asserting that the FDA had not adequately considered public safety concerns during its approval process.
Supreme Court Involvement
The DOJ appealed to the Supreme Court, which issued a stay, temporarily preventing the order’s implementation until April 19.
The stay was extended to April 21, after which the Supreme Court blocked the order again, allowing mifepristone to remain on the market. Notably, Conservative Justices Clarence Thomas and Samuel Alito voted against extending the stay.
U.S. Solicitor General’s Statement
U.S. Solicitor General Elizabeth Prelogar emphasized the importance of the Supreme Court’s intervention, highlighting that the 5th Circuit’s ruling was the first time a court had questioned the FDA’s “expert judgment” in approving medication.
Erin Hawley, senior counsel at the Alliance Defending Freedom, expressed concerns about the FDA’s actions, stating that the removal of safeguards from the chemical abortion drug regimen could harm women’s health and undermine the rule of law.
Justice Department’s Commitment
Associate Attorney General Vanita Gupta reassured that the Department of Justice would continue to defend the FDA’s authority and expertise in this matter, emphasizing that mifepristone would remain available under the FDA’s approved conditions.
The Supreme Court’s decision to review the Biden administration’s mifepristone regulations has ignited a contentious legal battle with significant implications for women’s reproductive healthcare.
As the case unfolds, it will undoubtedly draw attention from all sides of the debate, and its outcome will shape the future of abortion access in the United States.