Why An Abortion Drug Approved 20 Years Ago Might Get Yanked From The Market – By Maggie Koerth and Amelia Thomson-DeVeaux (FiveThirtyEight) / Feb 23, 2023
It’s less about science, and more about philosophy — particularly that of the Trump-appointed judge poised to rule on the approval.
Approving an abortion drug is always going to come with a high level of scrutiny and pushback. Dr. Michael Greene knew this well back in 2000 when he was leading the Food and Drug Administration committee that first approved the abortion drug mifepristone for sale in the U.S.
To Greene, now a professor emeritus of obstetrics and gynecology at Harvard University, that meant his team and the agency as a whole would need to be extremely cautious about ensuring mifepristone’s safety. “Four-plus conservative,” he calls it; an approach that led to an approval process that took more than three times as long as other drugs approved that year. It also resulted in a series of stringent, post-approval regulations that tightly controlled who could prescribe the drug, where patients could take it, what tests doctors needed to perform and even where the drug could be kept. “It had to be stored quite literally under lock and key,” Greene said.
But to abortion opponents who didn’t want to see mifepristone approved at all, those extra regulations seem less like an abundance of caution, and more like an admission that the drug was extremely dangerous. “They needed to use that authority because the FDA at the time recognized the dangers with chemical abortion drugs,” said Erik Baptist, senior counsel for Alliance Defending Freedom, a conservative legal advocacy group that is representing a group of organizations challenging the FDA’s approval of the drug. By “shoehorning in” post-approval regulations, he said, the FDA was “recognizing the dangers [mifepristone] poses to women and girls who take it.”
CONTINUE > https://fivethirtyeight.com/features/mifepristone-lawsuit-fda-approval/
