The US Biotechnology Innovation Organization (BIO) has signed onto an amicus brief to challenge a District Court’s unprecedented ruling (related to the ‘morning after’ abortion pill mifepristone (marketed under the trade name Mifeprex) that would create regulatory barriers and potentially upend the US Food and Drug Administration’s (FDA) authority to approve life-saving and life-enhancing therapies to patients.
The BIO action adds to other protests, including US President Joe Biden, who said his administration would fight the Texas decision. Also, the FDA itself appealed the decision to the 5th Circuit Court of Appeals, noting that its approval of the drug in 2000 rested on a "comprehensive evaluation of the scientific data."
Additionally, over 300 biotech and industry executives signed an open letter on Monday calling for reversal of a federal judge's decision to halt the FDA approval of mifepristone.
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