A conservative federal judge in Texas could soon order the U.S. Food and Drug Administration to reconsider its 22-year-old approval for a pill used in the most common form of abortion in the United States, or order the approval revoked outright.
Julia Harte, Gabriella Borter and Brendan Pierson -
Some of the FDA's options could be politically and legally risky both for the agency and mifepristone suppliers, they said. At a hearing last week in Amarillo, Texas, anti-abortion groups asked U.S. District Judge Matthew Kacsmaryk to halt sales of mifepristone nationwide – even in states where abortion is legal – while their lawsuit against the FDA proceeds.The groups contend the agency used an improper process when it approved mifepristone in 2000 and did not adequately consider the drug's safety when used by girls under age 18.
That was the case in 2019 with Makena, a pre-term birth prevention drug. The manufacturer protested the FDA's action and subsequent administrative hearings dragged out, allowing Makena to be sold for more than three years before the drugmaker took it off the market this month. Some lawyers said the FDA might assert its enforcement discretion under Democratic President Joe Biden's administration, but acknowledged that would elicit political and even legal blowback.
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