ROCKVILLE, MARYLAND - APRIL 13: In this photo illustration, packages of Mifepristone tablets are displayed at a family planning clinic on April 13, 2023 in Rockville, Maryland. A Massachusetts appeals court temporarily blocked a Texas-based federal judge’s ruling that suspended the FDA’s approval of the abortion drug Mifepristone, which is part of a two-drug regimen to induce an abortion in the first trimester of pregnancy in combination with the drug Misoprostol.
Medical groups filed another petition in March 2019 to challenge these changes. Once again, the FDA ignored the law and, this time, waited for 994 days before rejecting the petition.it would allow “dispensing mifepristone through the mail … or through a mail-order pharmacy.”, alleging that its approval of Mifeprex and subsequent decisions weakening its safety restrictions were “arbitrary and capricious” under the Administrative Procedure Act.
In other words, “Hundreds of thousands of women will … need emergency care on account of [the FDA’s] actions. And because [the FDA] chose to cut out doctors from the prescription and administration of mifepristone, plaintiff doctors and their associations will necessarily be injured by the consequences,” the panel wrote.
Finally, the Fifth Circuit considered whether the plaintiffs had first exhausted any opportunity to address these issues with the FDA itself. The courts allow an exception to this requirement when such an administrative step would be futile. This is where the FDA’s failure to follow the law—dragging its feet for 14 years after the petition regarding the 2000 approval and for nearly three years after the petition regarding the 2016 safety rule changes—came back to bite it.
The second factor is whether the FDA would suffer “irreparable harm” if Kacsmaryk’s stay was not lifted. The FDA, it turns out, did not offer any evidence on this point at all.
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