Becerra warns mifepristone case could open door to challenges against other approvals

Xavier Becerra, secretary of the Department of Health and Human Services (HHS), warned that if the US Food and Drug Administration (FDA) loses the upcoming Supreme Court case involving the abortion drug mifepristone, it could jeopardize the regulatory approval process and lead to lawsuits challenging the approval of other products by the agency.

Speaking at the National Press Club on 8 February, Becerra addressed the potential consequences of FDA v. Alliance for Hippocratic Medicine case that is currently before the Supreme Court. A group of anti-abortion physicians and other advocates brought the case before the US District Court for the Northern District of Texas in 2022, arguing that FDA did not do its due diligence in ensuring the safety and efficacy of mifepristone before allowing it on the market. FDA appealed District Judge Matthew Kacsmaryk’s preliminary injunction that would have suspended the drug’s approval to the Fifth Circuit Court of Appeals in April 2023. The Fifth Circuit overturned part of Kacsmaryk’s ruling but walked back rules on distributing mifepristone by mail that FDA had enacted several years prior. As such, the drug can now only be prescribed after a face-to-face consultation with a physician instead of a telemedicine consultation and can not be purchased via mail-order.

The Supreme Court has stayed the Fifth Court’s order until it has reviewed the case and issued a ruling later this year.

During the Press Club event, Becerra was asked how he thinks the case will play out at the Supreme Court.

“What I can tell you is this, remove mifepristone and put your medication in the place of mifepristone, and now you'll understand the consequences of what the Supreme Court decision means,” said Becerra. “Because so many of the medications, so many of the medical devices, so many of the therapies that you and I and our fellow Americans count on are based on the FDA's actions to let America know that that product is safe and effective for the intended use.”

He further warned that if the regulatory review process that mifepristone was evaluated under is found to be defective by the Supreme Court, it could open the door to other lawsuits. Ultimately, he said that he thinks the justices will recognize that the decision will have consequences far beyond mifepristone.

“It is consequential in ways that most people don't recognize and that's why I think there will be sanity, at least in one of the institutions of the federal government when it comes time to reach a decision by the Supreme Court,” said Becerra.

Becerra warns mifepristone case could open door to challenges against other approvals

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