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Richter is considering a ban on the abortion pill in the US and is questioning regulatory approval

By Gabriella Borter and Brendan Pierson

AMARILLO, Texas (Reuters) – A U.S. judge on Wednesday questioned lawyers for President Joe Biden’s administration about whether federal regulatory approval for the abortion pill mifepristone, granted 22 years ago, was appropriate when he met a request by anti-abortion groups to ban its sale reviewed the drug nationwide.

US District Judge Matthew Kacsmaryk, during a hearing in Amarillo, urged 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 decision to leave the drug on the market but reimpose some restrictions lifted by Biden’s administration, including requiring it to be delivered in person rather than through the mail. Kacsmaryk, who was appointed to the bench by ex-President Donald Trump, said he would govern “as soon as possible”.

It is shaping up to be the most momentous abortion case since the US Supreme Court, spurred by its conservative majority, delivered its landmark Roe v. Wade repealed the 1973 law that recognized a constitutional right to abortion.

Anti-abortion groups sued the US Food and Drug Administration in November, alleging that the agency used an improper process in approving mifepristone in 2000 and failed to adequately consider the drug’s safety for use by girls under 18.

The plaintiffs are asking Kacsmaryk for a temporary order to halt the sale of mifepristone nationwide – even in states where abortion is legal – while their court case continues.

According to the Guttmacher Institute, a research organization that advocates for abortion rights, 12 of the 50 states now ban abortion outright, while many others ban it after a certain gestational age. A ruling against the FDA would impede access to abortion in every state, since medical abortions — using mifepristone as part of a two-pill regimen — account for more than half of abortions in the US.

The judge listened intently and asked questions for more than four hours in a windowless courtroom in a small Northwest Texas courthouse.

Erik Baptist, a lawyer representing the plaintiffs with conservative rights group Alliance Defending Freedom, said the scope of the judge’s ruling should be “general and statewide.”

The judge questioned Biden administration attorneys about how the FDA expedited approval of mifepristone in a process normally used for drugs used to treat HIV infection and other life-threatening diseases. The government has said the drug’s approval was well supported by science and that the challenge comes far too late.

“PUBLIC DAMAGE”

Attorneys for the U.S. Department of Justice and an attorney for mifepristone’s manufacturer, Danco Laboratories, argued that the plaintiffs did not have the right to bring the case, saying mifepristone has an impressive safety and efficacy record.

“An injunction here would turn the status quo on its head. An injunction would cause significant public damage,” Justice Department Attorney Julie Straus Harris told the judge.

Harris also argued that a ruling in favor of the plaintiffs would undermine trust in the FDA, the agency charged with underwriting food and drug safety in the United States. Harris said such a ruling would also increase the burden on surgical abortion clinics, which are already overcrowded as they accept patients from states where clinics were closed after last year’s Supreme Court decision.

Mifepristone is available under the brand name Mifeprex and as a generic. In conjunction with another drug called misoprostol, it is approved for abortion within the first 10 weeks of pregnancy. The FDA said in January that the government would allow mifepristone to be sold in retail pharmacies for the first time.

Major medical organizations, including the American College of Obstetricians and Gynecologists, have sided with the FDA, stating that mifepristone “has been thoroughly studied and is completely safe.”

Abortion rights advocates, who claim the lawsuit is a baseless attempt to restrict access to abortion, protested outside the courthouse on Wednesday morning. One was dressed as a kangaroo and carried a gavel, suggesting the hearing was a “kangaroo court”.

By filing the lawsuit in Amarillo, where the Alliance for Hippocratic Medicine had been formed just three months earlier, the plaintiffs ensured the case would be heard before Kacsmaryk, a conservative former Christian activist. His courthouse has become a prime target for Republicans looking to challenge aspects of Democrat Biden’s agenda.

Kacsmaryk’s final decision will likely be immediately appealed by the losing side in the US 5th Circuit Court of Appeals in New Orleans, with the US Supreme Court a possible next step thereafter.

The 5th Circuit has a conservative reputation, with more than two-thirds of its judges appointed by Republican presidents. The Supreme Court has a Conservative majority of 6-3.

(Reporting by Gabriella Borter in Amarillo, Texas and Brendan Pierson in New York; Additional reporting by Liliana Salgado in Amarillo; Editing by Will Dunham and Alexia Garamfalvi)

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