Explainer-Texas Judge Suspends Approval of Abortion Pill. What Happens Next?

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(Reuters) – U.S. district judge Matthew Kacsmaryk, in Amarillo Texas, suspended Friday approval of the abortion drug mifepristone. This will essentially make the sale of the pill illegal while a legal case proceeds.

The legal battle about medication abortion has only just begun. It could take months or even years to resolve. What you need to be aware of as the case unfolds is:

What is medication abortion?

The medication abortion is a two drug regimen consisting of misoprostol and mifepristone used to end a pregnancy in the first 10 weeks. More than half of all abortions in the United States are performed with this method.

What has happened so far?

Last year, anti-abortion groups including the Alliance for Hippocratic Medicine in Texas sued the U.S. Food and Drug Administration. They claimed that the FDA approved mifepristone for use as an abortion drug in 2000 by using a process illegal and without considering the safety of the drug. They asked Kacsmaryk not to approve the drug.

Kacsmaryk’s order isn’t a final decision on the merits, but a preliminary injunction. This means that the drug will be banned while the case continues. Kacsmaryk, like all federal judges can issue injunctions that have nationwide effect even though he's assigned to a district in Texas.

What will the BIDEN administration do first?

The Biden Administration is asking the 5th U.S. Circuit Court of Appeals in New Orleans to grant an emergency stay on Kacsmaryk’s order. Circuit Court of Appeals. This would prevent the order from going into effect until this court heard a full appellate.

Kacsmaryk already put Kacsmaryk's own order on hold seven days to give the administration the time to apply for the emergency stay.

The 5th Circuit is known for its conservative reputation. Twelve of the 16 judges who are currently active were appointed by Republican Presidents. The decision to grant a stay will be made by a three-judge panel, which will also consider whether the agency will succeed in the case.

What if the 5th CIRCUIT does not grant a stay?

The FDA can then petition the U.S. Supreme Court to grant an emergency stay. The 5th Circuit will first send emergency petitions to Justice Samuel Alito. Alito is one of the most conservative judges on the court and was the author of Roe v. Wade last year, which overturned abortion rights in the United States.

The full court is usually notified of emergency petitions, but individual justices can decide on them themselves. These petitions are typically decided without much argument or explanation. For this reason, they're often referred to as the "shadow docket" of the court.

What does a stay mean for MIFEPRISTONE

If the FDA is successful in obtaining a stay to block the injunction then mifepristone remains FDA approved for the duration of the stay. In the event that it fails to do so, the FDA can be ordered by a court to revoke the approval. It will then be illegal to market the drug in the United States. It is unclear whether the FDA will take enforcement action against the continued use of this drug.


The FDA will appeal Kacsmaryk’s preliminary injunction regardless of whether or not it receives an emergency stay. Both the agency and anti-abortion organizations will have the chance to submit briefs in support of their legal arguments to the 5th Circuit. A three-judge panel could decide to hold oral arguments.

The 5th Circuit won't be examining the merits of the case but will only consider whether Kacsmaryk acted correctly in issuing a preliminary order. It depends on whether plaintiffs who are challenging mifepristone approval have demonstrated a probability that they will succeed on the merits and that their harm would be irreparable without an injunction.

This appeal process may last for months. The losing party can appeal the decision of the panel to all the judges in the 5th Circuit (known as an en banc hearing) and then petition the Supreme Court. Most of these petitions are rejected.

What's next?

After all appeals regarding the preliminary injunction have been exhausted, the case will proceed to a trial on the merits. This gives both sides the opportunity to present evidence.

The FDA must provide evidence of the processes that led to the original approval of mifepristone in 2000 as well as the subsequent actions taken to modify the approval process and the rules surrounding the drug.

The anti-abortion group will be required to provide evidence in support of their claims that the procedure was unconstitutional and that mifepristone poses a danger. Both sides will exchange evidence through a discovery process.

Kacsmaryk can then decide the case, also known as summary judgement, without a trial. Or, he can hold a full trial with witness testimony.

The final decision could take months or even years. The losing side can appeal the decision to the 5th Circuit Court and ultimately the Supreme Court.