The US Food and Drug Administration (FDA) first approved mifepristone in 2000, under its brand name Mifeprex. Credit: Anna Moneymaker / Staff via Getty Images.

The New Orleans-based Fifth US Circuit Court of Appeals remained steadfast in a ruling to heavily restrict access to the abortion pill mifepristone on 16 August.

The court decision banned telemedicine prescriptions and mail orders of the drug, which will take effect upon Supreme Court review. This could potentially happen in its upcoming term from October 2023 to June 2024.

The US Food and Drug Administration (FDA) first approved mifepristone in 2000, under its brand name Mifeprex, imposing several conditions to prevent potentially serious medical side effects from the drug. However, in 2016, the organisation lightened these restrictions. The agency followed this with approval of the drug’s generic version in 2019. In 2021, the FDA further reduced restrictions such that therapy did not need to be prescribed solely in person. Finally, earlier this year, the regulator approved mifepristone for over-the-counter use, increasing access to those in need.

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In the US, mifepristone is sold by Danco Laboratories in its branded version while GenBioPro sells a generic version of the drug. The abortion pill has been the subject of several heated debates in 2023, surrounding its over-the-counter approval, and a Texas appeals court decision amongst other things.

The 16 August appeal decision centred around the drug’s 2000 approval, the 2016 removal of prior protections for mifepristone, the generic approval and the 2021 amendment. The Alliance for Hippocratic Medicine, a Christian association of doctors who advocate for ethical medical practices, plus similar organisations and individual doctors, challenged these actions. The group argued that the FDA had taken unlawful action under the Administrative Procedure Act, by “[overlooking] important safety risks in approving mifepristone and amending its restrictions”.

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The Administrative Procedure Act was instilled in 1946 to govern the way in which federal agencies develop and issue regulations.

The White House’s press secretary Karine Jean-Pierre stated the Biden Administration’s strong disagreement with the ruling in a same-day press release. She said: “If the Fifth Circuit’s ruling stands, it will significantly roll back the ability for women in every state to get the healthcare they need, and undermine FDA’s scientific, evidence-based process for approving safe and effective medications that patients rely on.”

The US Supreme Court will have the opportunity to overturn the Appeals Court decision, following its landmark 2022 overturning of the Roe versus Wade ruling that had legalised abortion nationwide.