Will Mifepristone Be Recalled If Texas Ruling Remains In Effect? Biopharma Leaders Back FDA
It is ‘up in the air’ what manufacturers and the FDA will have to do if an appeals court does not stay the injunction against mifepristone. More than 400 biopharma industry leaders sign a letter calling for reversal of Judge Kacsmaryk’s order and supporting the FDA’s regulatory authority.
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After sitting out the initial rounds, trade group backs FDA’s decisions on the medication abortion pill and asks Supreme Court to stay Texas district court ruling suspending the drug’s approval.
Supreme Court stays Texas district court’s order until 19 April. FDA’s deputy principal commissioner says if it goes into effect, sponsors will have to submit additional applications, prescribers may need to be recertified, and FDA will have to reinstate higher dosing regimen.
BIO signs on while PhRMA and AAM stay on the sidelines as 169 companies, executives and investors file amicus brief supporting FDA’s request for stay of Judge Kacsmaryk’s decision to halt approval of the medication abortion drug. Members of Congress file opposing briefs.