On Wednesday, a hearing took place in Texas regarding the FDA approval of mifepristone, the abortion pill, where a judge heard plaintiffs suggest that the pill should be taken off of the market after it has been available for 22 years, according to Reuters.
The news: U.S. District Judge Matthew Kacsmaryk left the hearing without presenting a ruling, but did offer the suggestion that the drug could be offered on a more restricted basis, requiring it to be dispensed in person instead of by mail.
- The hearing lasted for four hours, and the judge said he would make a ruling as soon as possible, per Reuters.
- Lawyers for anti-abortion groups presented their case to the judge, claiming that the abortion pill is unsafe and that the FDA made mistakes upon approving the drug, The New York Times reported.
- Lawyers from the Department of Justice who represented the FDA countered by saying that mifepristone is safe and that the plaintiffs had no legal basis to file the lawsuit because none of them could prove that approval of the drug had caused them harm, the Times continued.
Details: Attorney Erik Baptist told the judge that taking mifepristone from the market would “restore proper policing power to the states,” per AP.
- Plaintiffs argue that pregnancy is “not a disease,” stating that approval of the drug should not have been accelerated. The FDA’s lawyers rebutted, saying that pregnancy is a medical condition and can be serious in life-threatening cases.
The bigger picture: Reuters says that Kacsmaryk’s final ruling is likely to be immediately appealed by the losing party to the 5th U.S. District Court of Appeals, with the possibility of the case moving to the Supreme Court after that.
The case: The original lawsuit against the FDA was filed by anti-abortion groups in November, Reuters reported.
- The Alliance for Hippocratic Medicine, an organization including five anti-abortion groups, filed the suit. It claims that the FDA did not follow proper protocols when approving the drug in 2000 and that the FDA ignores the safety risks of the drug, per the Times.
- Lawyers for the FDA said that it followed all legal processes when approving the drug. They stated that removing mifepristone from the market could “cause significant harm, depriving patients of a safe and effective drug that has been on the market for two decades,” according to the Times.