Court Slaps Down FDA Again For Illegally Dropping Abortion Pill Rules

Despite the intense focus on the FDA's decision to remove these restrictions, this case is more about whether the FDA followed the law in doing so.

The FDA approved mifepristone, under the trademark Mifeprex, in September 2000 not through its normal evaluation process, but under special "Accelerated approval" rules for drugs intended to treat "Serious or life-threatening illnesses."

The FDA had violated the act, the organizations claimed, because its decisions to approve Mifeprex through the accelerated process and to drop safety restrictions for its use were "Arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law."

Having exhausted options within the FDA, four medical associations and four individual physicians filed a federal lawsuit in Texas in November 2022, challenging both the original 2000 FDA approval of Mifeprex and the 2016 and 2021 decisions to lift safety restrictions.

The plaintiffs did have standing to sue, and while their challenge to the original FDA approval of Mifeprex came too late, the FDA's decision to drop the drug's safety restrictions in 2016 and 2021 were arbitrary and capricious.

First, rather than examine the effect of dropping several safety restrictions at once, the FDA looked only at the effect of dropping individual restrictions.

Second, the FDA dropped the requirement of reporting non-fatal medical complications in 2016, and then, in 2021, claimed the absence of data on non-fatal medical complications justified dropping the in-person dispensing requirement. 

https://www.dailysignal.com/2023/08/18/5th-circuit-slaps-down-fda-again-illegally-dropping-abortion-pills-safety-rules/