US Courts Threaten the Abortion Drug Mifepristone

The US Supreme Court is set to hear the most important reproductive rights case since the fall of Roe, after a Texas judge ruled to restrict access to the abortion drug mifepristone. Judge Matthew Kacsmaryk’s ruling is unprecedented in its attempt to overturn well-established and scientifically-supported FDA regulations. In response, Democratic governors all over the US have moved to stockpile abortion medications should his ruling be upheld.

Abortion drugs have become a focal point for anti-abortion activists after Roe was overturned, and abortion ostensibly made a ‘states issue’. If Kacsmaryk’s ruling is upheld, it will prevent abortion access even in states that have enshrined its legality since Roe’s fall.

What is mifepristone?

Mifepristone is one of two drugs in a medication abortion regimen approved for use in the US, along with misoprostol. Today, more than half of all US abortions use the mifepristone/misoprostol regimen. Furthermore, both drugs have healthcare uses beyond abortions.

Mifepristone was approved by the FDA back in 2000, with decades’ worth of scientific research confirming it is safe for use, despite claims made in the Texas lawsuit. It has since been in a select category of just 60 drugs that are thoroughly regulated and regularly reviewed.

Originally, mifepristone was approved for use up to seven weeks into pregnancy, though this timeframe was extended to ten weeks in 2016. Additionally, in 2021 the FDA allowed it to be dispensed by mail during the pandemic – a change made permanent in December last year.

The legal fight for abortion drugs

On the 7th of April, Texas judge Matthew Kacsmaryk ruled in favour of a lawsuit brought to his court by the conservative Christian legal group ADF (Alliance for the Defence of Freedom), invalidating mifepristone’s approval by the FDA.

This was entirely unprecedented – no lone judge has ever overturned the medical decisions of the FDA. But it was unsurprising – Kacsmaryk was an appointee of Trump, and was an anti-abortion advocate before his judicial career. He previously worked for First Liberty Institute, another conservative Christian group pushing anti-LGBT+ and anti-abortion legislation, and has referred to gay and transgender people as ‘disordered’.

It’s thought the ADF specifically chose to file their lawsuit in his jurisdiction given his very conservative ideologies.

Not only Kacsmaryk, but the fifth circuit court of appeals, to whom the case was forwarded after his ruling, is also considered very conservative. The appeals court agreed to put a hold on Kacsmaryk’s ruling, but reinstated the older, tighter rules around mifepristone’s distribution – namely the seven-week window and a requirement for in-person collection.

The FDA has strongly condemned both courts’ decisions, as has President Biden’s Office and the US Department of Justice.

Pharmaceutical executives have also expressed their condemnation of the ruling.

The DOJ has filed an emergency appeal to the Supreme Court to reinstate full access to the drug, although the success of such an appeal is unclear, given the Supreme Court’s conservative supermajority. On the other hand, as the Supreme Court is a federal body, just like the FDA, logic dictates they should side with the FDA, as federal law takes precedence over state law in the US.

In response to the legal scuffle for abortion drugs, Democratic governors have ordered stockpiles of mifepristone and misoprostol, promising to fight to protect access to medication abortions in their states.

Cover photo: “Lek Prevent zawierający mifepriston” by Yuchacz is licensed under CC BY-SA 4.0.

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