President Biden’s Administration Appeals to Supreme Court to Protect Access to Mifepristone

Currently, the 5th Circuit's decision is on hold, awaiting the outcome of the administration's Supreme Court appeal.

President Joe Biden’s administration has taken its fight to preserve broad access to the abortion pill mifepristone to the U.S. Supreme Court on Friday by appealing a lower court’s decision that would restrict the drug’s delivery and distribution.

The appeal, filed by the Justice Department, challenges the August ruling of the New Orleans-based 5th U.S. Circuit Court of Appeals, which sought to ban telemedicine prescriptions and mail shipments of mifepristone, with the drug’s manufacturer, Danco Laboratories, also lodging an appeal.

Currently, the 5th Circuit’s decision is on hold, awaiting the outcome of the administration’s Supreme Court appeal.

The Justice Department argues in its filing that allowing the 5th Circuit’s restrictions to take effect would harm women seeking lawful abortions and disrupt a healthcare system reliant on the current conditions of use for the drug.

This case potentially threatens the authority of the U.S. Food and Drug Administration (FDA), which granted approval for mifepristone in 2000.

Danco’s attorney, Jessica Ellsworth, asserts that the 5th Circuit’s decision disrupted the approved conditions for the use of Danco’s drug, Mifeprex, at the behest of plaintiffs who neither prescribe nor use the drug and who fundamentally oppose all forms of abortion.

Should the justices decide to hear the case, arguments could take place during the next term commencing in October, with a ruling expected by June 2024.

The 5th Circuit’s decision partly aligns with anti-abortion groups and doctors who contested mifepristone but does not go as far as a prior ruling by U.S. Judge Matthew Kacsmaryk in Amarillo, Texas, which would have suspended FDA approval and effectively removed the drug from the market.

In April, the Supreme Court temporarily halted Kacsmaryk’s order while litigation continued, granting emergency requests by the Justice Department and Danco Laboratories.

President Biden’s administration aims to defend mifepristone in response to increasing abortion bans and restrictions enacted by Republican-led states following the Supreme Court’s overturning of the landmark 1973 Roe v. Wade decision in June 2022, which had legalized abortion nationwide.

Mifepristone is a critical component of medication abortion, which accounts for over half of all U.S. abortions and serves other purposes, such as managing miscarriages.

The FDA has affirmed the drug’s safety and effectiveness over decades of use by millions of Americans, with adverse effects being exceptionally rare.

Anti-abortion groups, led by the Alliance for Hippocratic Medicine and four anti-abortion doctors, filed a lawsuit against the FDA last year.

Represented by the conservative religious rights group Alliance Defending Freedom, these challengers argue that the FDA unlawfully approved mifepristone and removed crucial safeguards from what they perceive as a hazardous drug.

The 5th Circuit’s August decision reversed FDA measures that had enhanced drug accessibility in recent years, including remote prescriptions and mail deliveries in 2021, replacing the requirement for in-person doctor visits, and an extension of the drug’s use to 10 weeks of pregnancy in 2016, up from seven.

Since the Supreme Court’s ruling last year, at least 14 U.S. states have implemented complete abortion bans, while many others have restricted abortion after specific pregnancy durations.

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