Biden officials defend mifepristone approval as abortion pill fight returns to appeals court

WASHINGTON – President Joe Biden's administration defended the approval of the abortion pill mifepristone in a federal appeals court filing Wednesday, the latest development in a case that may decide whether Americans have access to the drug.

The brief comes less than a week after the Supreme Court kept access by mail and telehealth in place for the drug on a temporary basis. That decision sent the underlying lawsuit back to the New Orleans-based U.S. Court of Appeals for the 5th Circuit, which is considering the challenge to the drug on an expedited basis. 

There's a good chance the legal fight over mifepristone will wind up back in front of the Supreme Court, potentially by the time the justices begin their next term in October and just over one year before the next presidential election.

The battle over mifepristone has landed as the nation is still grappling with the Supreme Court's decision last year to end the constitutional right to abortion Roe v. Wade established in 1973. With some states banning abortion in response to that ruling, being able to get mifepristone through the mail has become, in many places, one of the few avenues left to get an abortion.

The administration asserted that the district court's decision to suspend approval of mifepristone was, to its knowledge, the first time any court had tried to step in to overturn the FDA's approval of a drug "based on disagreement with the agency's judgment about safety – much less done so after that approval has been in effect for decades."

A coalition of anti-abortion groups is challenging the process the Food and Drug Administration used to approve the drug. Their response to the Biden administration is due May 8 and the appeals court will hear arguments May 17.   

The drama over the drug began earlier this month when a pair of federal court rulings on April 7 plunged the fate of mifepristone into uncertainty. One of those rulings, from U.S. District Judge Matthew Kacsmaryk, effectively invalidated the FDA's 23-year-old approval for the drug. Days later, the 5th Circuit sided with the Biden administration on the drug's approval but let stand on a temporary basis the parts of Kacsmaryk's ruling that halted efforts to expand access to the drug.

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Those expansions included FDA actions that allowed Americans to receive the drug through the mail and that allowed pharmacists to prescribe the drug. In an unsigned, one-paragraph order on April 21, the Supreme Court allowed those FDA actions to stand while the underlying legal fight over the drug continues.

"FDA's 2000 approval of mifepristone was lawful," the Biden administration told the appeals court. "FDA reasonably explained its decision, relying on multiple clinical trials that demonstrated the drug's safety and efficacy."