FDA may allow unapproved use of medical products during emergencies

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.

EUA Criteria

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.

EUA Requests

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.

Highlight on Florida: Hurricane causes hospital closures, requires extra support for vulnerable patients

Florida health care facilities were forced to make serious operating choices when Hurricane Matthew hit, and provided recommendations to the public that may be important during future emergency situations. In such situations, hospitals strive to allocate staffing and provisions to best meet patients’ needs, and rely on locals to seek shelter elsewhere.

Hospital closures, evacuations

The state of Florida faced some serious health care delivery concerns when Hurricane Matthew hit last week. Jackson Health System, a major hospital system in Miami, planned to operate as normally as possible, except for some clinics that closed Thursday and Friday. Broward Health, a five-hospital system, took the opposite approach and closed all hospitals except for emergencies and trauma patients. All outpatient procedures were canceled on Thursday and Friday. Baptist Health kept hospitals and emergency rooms open, but closed some of its centers. Cape Canaveral Hospital, Baptist Medical Center Beaches, and three Florida Hospital locations were forced to evacuate patients. Although Florida Hospital Flager remained opened for emergencies, Ormond Beach and New Smyrna Beach locations closed their ERs.

Storm considerations

Hospitals offered some advice for locals, and urged patients not to plan on using hospitals as a last-minute shelter option. One official said that every year, some individuals show up seeking to wait out the hurricane at the hospital, requiring staff to be diverted away from patient care. According to the Orlando Sentinel, counties established shelters for those with special needs that are staffed with nurses and have some equipment. Hospitals also warned that patients needing medications would not be able to pick them up at a hospital and would be forced to proceed through the ER to get prescriptions.

Jackson Health posted a special advisory for women planning to deliver their baby at one of its facilities, outlining who should report to the hospital when a hurricane warning takes effect. Women carrying multiple babies who are at least 34 weeks along, having a history of preterm labor, or have placental implantation issues at least 28 weeks into their pregnancy were encouraged to come to the hospital and be prepared for admission. Others were told to call their physician and report to the hospital if referred.

Other patients, such as those requiring oxygen and dialysis, were also particularly vulnerable in this situation. Over 500,000 such patients were in the hurricane’s path. Chen Senior Medical Centers identified many vulnerable patients and called them individually, asking about their conditions and needs. Oxygen was provided at no cost to those who needed it. There was also a federal Disaster Distress Helpline staffed to provide immediate crisis counseling.