AMARILLO, Texas--A U.S. judge on Wednesday questioned lawyers for President Joe Biden's administration on whether the federal regulatory approval given to the abortion pill mifepristone 22 years ago was proper as he considered a request by anti-abortion groups to ban sales of the drug nationwide.
U.S. District Judge Matthew Kacsmaryk during a hearing in Amarillo also pressed the groups, led by the Texas-based Alliance for Hippocratic Medicine, to explain how he could reverse approval of a long-established drug.
The judge raised the possibility of a more limited ruling, keeping the drug on the market but re-imposing some restrictions lifted by Biden's administration, including requiring it to be dispensed in person rather than by mail. Kacsmaryk, appointed to the bench by former President Donald Trump, said he would rule "as soon as possible."
It is shaping up as the most consequential abortion case since the U.S. Supreme Court, powered by its conservative majority, last year overturned its landmark 1973 Roe v. Wade ruling that had recognized a constitutional right to terminate a pregnancy. The anti-abortion groups sued the U.S. Food and Drug Administration in November, contending the agency used an improper process when it approved mifepristone in 2000 and did not adequately consider the drug's safety when used by girls under age 18.
The plaintiffs are asking Kacsmaryk for a preliminary order halting sales of mifepristone nationwide - even in states where abortion is legal - while their lawsuit proceeds.
Twelve of the 50 states now ban abortion outright while many others prohibit it after a certain length of pregnancy, according to the Guttmacher Institute, a research organization that supports abortion rights. A ruling against the FDA would hinder abortion access in every state as medication abortion - with mifepristone part of a two-pill regimen - accounts for more than half of U.S. abortions.
The judge heard arguments in a windowless courtroom in a small courthouse in the northwest corner of Texas for more than four hours, listening intently and asking questions. Erik Baptist, a lawyer with the conservative legal group Alliance Defending Freedom representing the plaintiffs, said the scope of the judge's ruling should be "universal and nationwide."
The judge questioned lawyers for Biden's administration on how the FDA accelerated its approval for mifepristone under a process typically used for drugs to treat HIV infection and other life-threatening illnesses. The administration has said that the drug's approval was well supported by science, and that the challenge comes much too late.
Lawyers for the U.S. Justice Department and an attorney for mifepristone's manufacturer, Danco Laboratories, argued that the plaintiffs had no standing to bring the case, and said mifepristone has an impressive safety and efficacy record. "An injunction here would upend the status quo. An injunction would cause significant public harm," Justice Department attorney Julie Straus Harris told the judge.
Harris also argued that a ruling in favour of the plaintiffs would undercut trust in the FDA, the agency charged with signing off on the safety of food products and drugs in the United States. Harris said such a ruling would also increase the burden on surgical abortion clinics, already overcrowded as they admit patients from states where clinics have closed in the wake of last year's Supreme Court decision.
