The US Supreme Court on Friday temporarily blocked a lower court’s order that would have banned the abortion pill mifepristone.
and a 2016 change that allowed the pill to be taken up to the 10th week of pregnancy.
“There is a very detailed procedure of removing drugs from the market,” says Ameet Sarpatwari, a lawyer and assistant professor of medicine at Harvard Medical School. Kacsmaryk’s ruling circumvents that established process, Sarpatwari says. Manufacturers and the FDA have, either because of low demand or dangers to patients, but a court has never stepped in to pull a long-approved drug from use.
There are a few scenarios in which mifepristone could remain available—or come back onto the market—even if the Supreme Court affirms Kacsmaryk’s ruling to pull its approval, Sarpatwari says. The FDA could exercise its “enforcement discretion,” meaning the agency wouldn’t prosecute manufacturers, distributors, or providers making the drug available. Another option is that the FDA could rapidly reapprove mifepristone based on decades of scientific studies that back up its safety and efficacy.
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