In the event of emergencies, such as pandemic threats or attacks involving chemical, biological, radiological, and nuclear (CBRN) agents, the FDA may authorize emergency use of medical products that are unapproved, or of approved products for an unapproved use. The FDA may take action to employ “medical countermeasures” (MCMs) after a relevant U.S. agency has declared an emergency or threat justifying such use.
Emergency Use Authorizations
The FDA’s emergency use authorization (EUA) power is distinct from the power to use a medical product under an investigational application. Before an EUA may be issued, the HHS Secretary must make an EUA declaration based on one of the following:
- the Secretary of Homeland Security’s determination that there is a domestic emergency, or potential for emergency, involving a risk of attack with a CBRN agent;
- the Secretary of Defense’s determination that there is a military emergency, or potential for emergency, involving a risk of attack on U.S. military forces involving CBRN agents;
- the Secretary of HHS’ determination that there is a public health emergency, or potential for emergency, that would affect national security or the health and security of U.S. citizens living abroad, involving a CBRN agent or related disease; or
- the Secretary of Homeland Security’s identification of a material threat sufficient to affect national security of the health of US citizens living abroad.
After the EUA declaration is issued, the FDA Commissioner is expected to confer, to the extent feasible and appropriate, with the Assistant Secretary for Preparedness and Response, the Director of the National Institutes of Health, and the Director of the Centers for Disease Control and Prevention, before authorizing emergency use of a product.
The CBRN agents in the EUA declaration must be capable of causing serious or life-threatening harm. Medical products eligible to be considered for an EUA require a lower level of evidence than the typical effectiveness standard that the FDA uses when approving products, and are those with the possibility of effectiveness in preventing, diagnosing, or treating serious or life-threatening conditions. The FDA may also make available products that might mitigate a disease or condition caused by an FDA product (including emergency use products) used due to the CBRN agent.
The product must be one that has benefits known to outweigh known and potential risks, as determined by assessing the totality of scientific evidence available. Additionally, there must be no adequate, approved, and available alternative to the product in an EUA. This criterion is satisfied if the potential alternative product lacks sufficient supplies, is contraindicated for special populations, lacks an approved dosage form for special populations, or may not withstand the CBRN agent.
Although most EUA requests will likely be submitted by government agencies, industry sponsors are eligible to submit such a request. In the event that a sponsor wishes to do so, the FDA recommends the inclusion of an organized summary of scientific evidence supporting a product’s safety and effectiveness, as well as approved alternatives. Other relevant information includes a description of the product and its intended use, a description of the product’s FDA approval status, the need for the product, and information about the adequacy and availability of approved alternative products.