A U.S. judge in Texas is set to hear arguments Wednesday in a bid by anti-abortion groups to ban sales of the abortion pill mifepristone across the country, even in states where abortion is legal, as they challenge regulatory approval granted more than two decades ago.
Dozens of journalists and people planning to attend the hearing gathered before dawn outside the federal courthouse in Amarillo. The Texas-based Alliance for Hippocratic Medicine and other groups are asking U.S. District Judge Matthew Kacsmaryk for a preliminary order halting sales of the drug while their lawsuit proceeds.
The hearing is scheduled to begin at 9 a.m. local time. Protests, organized in part by the feminist organization Women's March, are expected outside the courthouse.
The 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 to terminate a pregnancy.
President Joe Biden's administration, responding to the lawsuit, has said that the drug's approval was well supported by science, and that the challenge comes much too late.
Legal experts have said the lawsuit could be the most consequential abortion case since the U.S. Supreme Court, powered by a conservative majority, last year overturned its landmark 1973 Roe v. Wade ruling that had recognized a constitutional right to abortion. Twelve of the 50 states now ban abortion outright while some others prohibit it after a certain length of pregnancy, according to the Guttmacher Institute, a research organization that supports abortion rights.
Mifepristone is part of the regimen in the United States for medication abortions, which account for more than half of all abortions in the country.
The judge could rule any time after hearing arguments. Any ruling is likely to be appealed immediately to the New Orleans-based 5th U.S. Circuit Court of Appeals.
Kacsmaryk had sought to keep news of the hearing from becoming public for as long as possible by delaying posting notice of when it would occur on the court's docket and asking lawyers to keep it secret. The judge cited death threats and harassment directed at the court during the case and a wish to avoid disruption. The unusual move drew an objection from several media organizations.
Mifepristone is available under the brand name Mifeprex and as a generic. Used in conjunction with another drug called misoprostol, it is approved to terminate a pregnancy within the first 10 weeks of a pregnancy. The FDA in January said that the government for the first time will allow mifepristone to be dispensed at retail pharmacies.
By suing in Amarillo, where the Alliance had been incorporated just three months earlier, the plaintiffs ensured that the case would go before Kacsmaryk, a conservative former Christian activist appointed to the bench by Republican former President Donald Trump. His courthouse has become a favored destination for Republicans seeking to challenge aspects of Democrat Biden's agenda.
The 5th Circuit also has a conservative reputation, with more than two-thirds of its judges appointed by Republican presidents.
The FDA said in a January court filing that the "public interest would be dramatically harmed" by pulling mifepristone from the market, forcing women to have unnecessary surgical abortions and greatly increasing wait times at already overburdened clinics.
Major medical organizations, including the American College of Obstetricians and Gynecologists, have weighed in on the side of the FDA, saying mifepristone "has been thoroughly studied and is conclusively safe."
Mifepristone is also the subject of lawsuits in West Virginia and North Carolina seeking to expand access to the drug by arguing that state restrictions conflict with federal law, and a lawsuit by Democratic state attorneys general seeking to remove federal restrictions on how it can be distributed.
The Texas lawsuit is now the furthest along of any of the cases. After appealing to the 5th Circuit, the losing side could seek to take the matter to the U.S. Supreme Court.
Kacsmaryk is also presiding over a pending lawsuit accusing media companies, including Reuters, of violating federal antitrust laws by working with tech companies to censor information about COVID-19. A Reuters spokesperson has denied the allegations.
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