The US government has filed an appeal against a Texas judge’s decision to block the FDA’s approval of a medication used for early abortions.
The appeal, filed on Monday, argues that the judge’s ruling is “legally erroneous” and “irreparably harms public health”. The medication, known as mifepristone or RU-486, has been approved by the FDA since 2000 and is used in combination with another drug, misoprostol, to end pregnancies up to 10 weeks. The Texas judge, Sam Sparks, issued a preliminary injunction on March 31 that suspended the FDA’s approval of Mifepristone, saying that it poses “serious health risks” to women and that the agency did not follow proper procedures when it relaxed some of the restrictions on the drug in 2016.
The judge’s ruling came in response to a lawsuit filed by several anti-abortion groups and individuals who claimed that the FDA’s approval of Mifepristone violated federal law and the Constitution. The US government’s appeal says that the judge’s ruling is based on “flawed factual findings” and “misapprehends the relevant legal standards”.
It also says that the ruling interferes with the FDA’s authority to regulate drugs and protect public health, and that it deprives women of access to a safe and effective option for ending unwanted pregnancies. The appeal also notes that several states, including California, New York and Illinois, have been stockpiling Mifepristone in anticipation of a possible nationwide ban on the drug.
The appeal asks the Fifth Circuit Court of Appeals to stay the judge’s ruling pending a final resolution of the case.