The FDA knew:
Section 564, as amended by PAHPRA, permits the Commissioner6 to authorize the emergency use of an unapproved medical product or an unapproved use of an approved7 medical product for certain emergency circumstances (discussed in section III.A of this guidance) after the HHS Secretary has made a declaration of emergency or threat justifying emergency use. The Commissioner may issue an EUA to allow an MCM to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by a CBRN agent when there are no adequate, approved, and available alternatives. Section III of this guidance addresses EUAs.