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Was the FDA wrong to approve a drug that’s used in nearly all medication abortions in the U.S. — and should the drug, mifepristone, be taken off the market? Those questions are being argued in court Wednesday, in a case heard by controversial federal judge Matthew Kacsmaryk in Amarillo, Texas.
If the case succeeds, it could have sweeping repercussions — for abortion clinics and patients across the nation, as well as for the FDA’s drug-approval process. At least 25 states have filed amicus briefs in the case.
Here’s a guide to what’s at stake in the lawsuit:What will happen Wednesday?
Each side will have two hours to present their arguments. The judge could rule at any time after hearing the two sides.
The anti-abortion groups say the FDA used a flawed process to approve the medicine; they also say it should not have increased the term in which the drug is approved for use: In 2016, the agency changed its guidance allowing use in the first 10 weeks of pregnancy, up from seven weeks.
The FDA says it approved the drug more than 20 years ago after „a thorough and comprehensive review of the scientific evidence presented and determined that it was safe and effective for its indicated use.“What could the judge do?
Kacsmaryk has a few options, from leaving the drug on the market to restoring rules around mifepristone that the Biden administration recently eased. Those changes include allowing mifepristone to be mailed or dispensed by retail pharmacies.
The judge could order a halt to either or both of those practices. Or he could order the FDA to take the drug off the market altogether.
Whatever he decides, the ruling will likely be appealed, and it’s very possible the case will end up before the Supreme Court.Abortion opponents sued the FDA in November
The case is titled Alliance for Hippocratic Medicine v.
