Another Anthrax Alert by the HHS Dept.

The Authorization contains, among other things,
conditions on the emergency use of doxycycline hyclate tablet emergency
kits. The Authorization follows the determination by the Secretary of
the Department of Homeland Security that there is a significant
potential for a domestic emergency, involving a heightened risk of
attack with a specified biological, chemical, radiological, or nuclear
agent or agents--in this case, Bacillus anthracis.

Among other things, section 564 of the act allows FDA to authorize the use of an unapproved medical product or an unapproved use of an approved medical product during a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a specified biological, chemical, radiological, or nuclear agent or agents.

. . . the Secretary must declare an emergency justifying the authorization based on one of the following grounds:

. . .a domestic emergency, or a significant potential for a
domestic emergency, involving a heightened risk of attack with a
specified biological, chemical, radiological, or nuclear agent or
agents;

. . .military emergency, or a significant potential for a military
emergency, involving a heightened risk to United States military forces
of attack with a specified biological, chemical, radiological, or
nuclear agent or agents.

. . .A determination by the Secretary of a public health emergency
under section 319 of the Public Health Service Act (PHS Act) that
affects, or has a significant potential to affect, national security,
and that involves a specified biological, chemical, radiological, or
nuclear agent or agents, or a specified disease or condition that may
be attributable to such agent or agents.

The Secretary has delegated his authority to issue an EUA under section 564 of the act to the Commissioner of Food and Drugs.

Were the government to determine in the future that there is a heightened risk of an anthrax attack--if, for example, there were credible information about an imminent threat of such an attack--that would almost certainly result in a domestic emergency. That is so, among other important reasons, because those exposed to Bacillus anthracis need to take appropriate antimicrobials rapidly after exposure to avoid contracting anthrax and because of the significant challenges to rapidly delivering such antimicrobials to those at risk in an anthrax emergency.