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Anti-abortion groups are seeking to ban the sale of the abortion pill, Mifepristone, across the United States, even in states where abortion is legal. The groups, led by the Texas-based Alliance for Hippocratic Medicine, are challenging the drug’s regulatory approval, granted over two decades ago. They asked U.S. District Judge Matthew Kacsmaryk in Amarillo for a preliminary order halting drug sales while their lawsuit proceeds. The groups sued the U.S. Food and Drug Administration (FDA) in November, arguing that the agency used an improper process when approving Mifepristone in 2000 and did not adequately consider the drug’s safety when used by girls under 18 years old to terminate a pregnancy.
Legal experts suggest that this lawsuit could be the most significant 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. The ruling led to 12 of the 50 states in the U.S. banning abortion outright, while some others prohibit it after a certain length of pregnancy. Mifepristone is a part of the regimen in the United States for medication abortions, which accounts for more than half of all abortions in the country.
The judge could rule anytime after hearing arguments, and any ruling is likely to be appealed immediately to the New Orleans-based 5th U.S. Circuit Court of Appeals. The judge’s courthouse has become a favored destination for Republicans seeking to challenge aspects of Democrat Joe Biden’s agenda. The 5th Circuit also has a conservative reputation, with more than two-thirds of its judges appointed by Republican presidents.
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 ten weeks of pregnancy. In January, the FDA said that the government would allow Mifepristone to be dispensed at retail pharmacies for the first time. In a January court filing, the FDA said that the “public interest would be dramatically harmed” by pulling Mifepristone from the market, forcing women to have unnecessary surgical abortions and significantly increasing wait times at already overburdened clinics.
Major medical organizations, including the American College of Obstetricians and Gynecologists, have supported the FDA, saying that mifepristone “has been thoroughly studied and is conclusively safe.” The FDA maintains that the drug’s approval was well-supported by science and that the challenge comes too late. However, 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.
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In the Texas lawsuit, 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 objection from several media organizations.
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.
The legal battle over the sale of Mifepristone, a medication used for terminating pregnancies, is becoming a significant abortion case in the United States. Anti-abortion groups seek to ban the drug’s sale across the country, arguing that its regulatory approval was improper and that its safety for minors was not adequately considered. However, major medical organizations have supported the drug’s safety, and the FDA has warned that banning it would harm the public interest. The judge presiding over the case in Texas has a conservative reputation, and any ruling is likely to be appealed immediately. This case highlights the ongoing debate over abortion rights and the challenges facing those seeking to protect access to safe and legal abortion care in the United States.
