Secretary of Health and Human Services (HHS) Tom Price last week issued a “Determination and Declaration Regarding Emergency Use of Injectable Treatments for Nerve Agent or Certain Insecticide (Organophosphorus and/or Carbamate) Poisoning,” authorizing emergency use of injectable treatments for nerve agent or certain weaponized insecticides.
Price determined that there is a significant potential for a public health emergency affecting national security or the health and security of U.S. citizens living abroad, and that involves nerve agents or certain insecticides (organophosphorus and/or carbamate).
Under Section 564 of the FD&C Act, the Commissioner of the Food and Drug Administration (FDA), acting under delegated authority from the Secretary of HHS, may issue an Emergency Use Authorization (EUA) authorizing the emergency use of an unapproved drug or an unlicensed biological product; or an unapproved use of an approved drug, approved or cleared device, or licensed biological product.
Before an EUA may be issued, the Secretary of HHS must declare that circumstances exist justifying the authorization based on one of four determinations:
- A determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a chemical, biological, radiological, or nuclear (CBRN) agent or agents
- The identification of a material threat by the Secretary of Homeland Security pursuant to section 319F–2 of the Public Health Service (PHS) Act 1 sufficient to affect national security or the health and security of United States citizens living abroad
- A determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to United States military forces of attack with a CBRN agent or agents
- A determination by the Secretary of HHS that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of United States citizens living abroad, and that involves a CBRN agent or agents, or a disease or condition that may be attributable to such agent or agents
Based on any of these four determinations, the Secretary of HHS may then declare that circumstances exist that justify the EUA, at which point the FDA Commissioner may issue an EUA if the criteria for issuance of an authorization under section 564 of the FD&C Act are met.
The Centers for Disease Control and Prevention (CDC) requested that the FDA issue an EUA for use of an injectable treatment for nerve agent and certain insecticide (organophosphorus and/or carbamate) poisoning to support preparedness and response to potential public health threats posed by these agents and compounds.
At this time, FDA-approved injectable treatments for nerve agent or certain insecticide (organophosphorus and/or carbamate) poisoning are not available to replenish the Department’s Strategic National Stockpile 3 inventory when the products in the current inventory expire. Pending the availability of such products, an EUA will facilitate ensuring that the products are available in the event of a public health emergency requiring these countermeasures.
The determination of a significant potential for a public health emergency, and the declaration that circumstances exist justifying the authorization of emergency use of these countermeasures by the Secretary of HHS, enables the FDA Commissioner to issue an EUA for certain injectable treatments for emergency use under section 564 of the FD&C Act.
Source: Federal Register
