A conservative federal appeals court in New Orleans appeared skeptical of the Biden administration's arguments for leaving intact the FDA's 2000 approval of a commonly used abortion pill, in a case that could disrupt the drug's availability nationwide.
by the 5th Circuit that narrowed the district court's injunction, allowing mifepristone to remain on the market, but leaving in place portions that rolled back the FDA's changes since 2016.to mifepristone while the appeals process plays out, though the case is almost certain to land before the justices again.
While it's understandable that an accelerated regime would be necessary for drugs treating cancer or AIDS, he said,"Why do you need to use that process here and does it even fit given that pregnancy almost certainly is not an illness?"Ho asked Jessica Ellsworth, who represented Danco Laboratories, a drug company that makes mifepristone and submitted the original new drug application to the FDA in 1996.
But Ho challenged that characterization as an"FDA-can-do-no-wrong theme" and said the FDA has on numerous occasions withdrawn drugs approved under the same rules as mifepristone. But lawyers for the Alliance Defending Freedom, which is representing the medical groups, argue that the FDA"put politics above women's health" when it approved mifepristone in 2000 and removed certain requirements surrounding access to it, including allowing it to be dispensed through the mail.
The FDA's backers are also sounding the alarm that if the district court's order is allowed to stand, it would undermine the agency's approval process for other drugs.
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