Three-Minute Legal Talks: The Abortion Drug Mifepristone’s Legal Battle

Mifepristone provides an effective form of abortion for women throughout the United States and in over 90 countries worldwide. In April, a Texas judge issued an order withdrawing the FDA’s 2000 approval of the drug after a group of doctors brought a case arguing that the decades-old approval was arbitrary and capricious. In a short period of time, the case made its way up to the United States Supreme Court, only to have the Court send it back down to the Fifth Circuit Court of Appeals. As the legal process continues, the drug’s FDA approval remains currently intact.

With the drug’s future uncertain, both sides of the abortion issue will be monitoring the legal battle closely. Follow along as Jessica West, a lecturer at UW Law, covers the case’s back-and-forth journey through the courts and how a decision in favor of anti-abortion groups could affect other drugs’ FDA approval as well.

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Jessica West: My name is Jessica West. I'm a lecturer at the University of Washington School of Law.

Three-Minute Legal Talks: What is the next step in the legal battle regarding the drug mifepristone?

JW: There are likely a number of steps in the legal battle regarding mifepristone. By way of background, in early April Judge Matthew Kacsmaryk out of Amarillo, Texas issued an order purporting to withdraw FDA approval for the abortion medication mifepristone nationwide. That order was appealed to the Fifth Circuit Court of Appeals, and without a full hearing, the Fifth Circuit Court of Appeals upheld parts of Judge Kacsmaryk’s order and itself purported to cut back on the FDA approval with regards to timing, during which the medication is permitted to be prescribed, as well as the approval of generic medication mifeprex. The FDA then appealed that Fifth Circuit order to the Supreme Court and after a tense week with some back and forth the Supreme Court has stayed, or postponed, implementation of the order, interfering with the FDA approval of mifepristone. So, that means that the medication will remain available while that Texas case proceeds through the appellate process. The Supreme Court then sent the case back to the Fifth Circuit to more fully consider the issues.

TMLT: What is the core argument from anti-abortion groups regarding the drug?

JW: With regards to the Texas case, that is a case brought by some doctors who don't themselves prescribe abortion medication, but they are asking courts to find arbitrary and capricious the FDA’s approval of the medication mifepristone.

It's unclear, first of all, why these doctors would even have standing as they would have to show some claim of harm to themselves. But in addition, it's a stretch of a legal argument, given that the medication mifepristone has been shown to be incredibly safe and effective over the course of the decades that it's been approved and used. Also, it's a stretch because the FDA clearly has responsibility to oversee medication approvals and took that responsibility very seriously with regards to mifepristone.

TMLT: How likely is it that the case will make its way back up to the Supreme Court?

JW: The mifepristone case will make its way back up to the Supreme Court. In fact, the Dobbs decision opened up a huge Pandora's box and I expect that many abortion cases will make their way up to the Supreme Court, as anti-abortion groups work to undercut state rights to allow safe and legal abortions.

TMLT: What is the current state of the drug’s availability?

JW: The drug is currently available nationwide wherever it's legal and permissible for doctors to prescribe it.

TMLT: If the FDA’s approval of mifepristone is overturned, could this affect other drugs’ FDA approval as well?

JW: Yes, it could, and drug companies are very concerned about the Texas case. Judge Kacsmaryk and the Fifth Circuit decisions are out of step with principles of administrative law and agency authority. And drug and pharmaceutical companies spend an enormous amount of money developing medications, and then following a very rigorous protocol laid out by the FDA to receive approval of those drugs. Some would say that the process is too rigorous, but it's rarely said that it's not rigorous enough, and that politics and courts could play such an enormous role with regards to the approval of medication. And then the unapproval of medication really undercuts the ability of companies to rely on the FDA approval process.