Role of FDA Emergency Use Authorization (EUA) Program Examined

July 27, 2007

A policy review published in the July 2007 edition of Emerging Infectious Diseases (EID) examines the utility of the Emergency Use Authorization (EUA) as a tool for approving public health countermeasures in the event of a national public health emergency.

Established by the BioShield Act of 2004, EUAs enable the Food and Drug Administration (FDA) to "approve the emergency use of drugs, devices and medical products" that are not already approved by the FDA.

According to the authors, this new tool "fills the need for timely and practical medical treatment under emergency conditions” and “authorizes use of the best product available" to treat a disease during a public health emergency, such as a pandemic.

EUAs can be issued by the FDA commissioner after the secretary of the Department of Health and Human Services (HHS) has declared an emergency. The EUA is issued if the FDA commissioner concludes:

The agent listed in the emergency declaration can cause a serious or life-threatening disease or condition;
A specific medical product can aid in diagnosing, preventing, or treating the disease;
The known and potential benefits of the product outweigh it risks; and
No adequate, approved alternative medical product is available. To guide the HHS secretary and the FDA commissioner on the use of the EUA, HHS has established an Emergency Use Authorization Working Group consisting of federal officials with expertise in public health, medicine, law, ethics and risk communication.

As the EID review explains, EUAs serve an important purpose in emergency settings because no matter how quickly the FDA can approve drugs and vaccines in non-emergency settings, in an emergency "there will always be promising drugs, biologic products and devices that do not have FDA approval." Additionally, certain drugs may have "off-label" uses that are not approved by the FDA but that could be effective in treating people in an emergency situation. Although physicians have the authority to prescribe drugs off-label on a patient-by-patient basis, there is no mechanism to allow doctors to do so on a large scale. The study explains that an EUA can authorize off-label use for "prevention, treatment or diagnosis under emergency circumstance."

Since its creation in 2004, the EUA program has been used only once. In 2005. DoD requested that an EUA be issued to vaccinate military personnel with an anthrax vaccine that had not yet received approval by the FDA for use as a large-scale bioterrorism countermeasure against inhalation anthrax. While the vaccine, Anthrax Vaccine Absorbed (AVA), awaited official approval, then-HHS Secretary Tommy Thompson issued a declaration of emergency. FDA Commissioner Lester Crawford then issued an EUA for AVA on Jan. 27, 2005.1 The EUA expired on Jan. 14, 2006, when AVA was granted FDA approval for its indication. As described in EID, the EUA was successful as it "cleared the way for DoD to resume anthrax vaccinations to protect military personnel."

References

1. Nightingale S, Prasher J, Simonson S. Emergency use authorization (EUA) to enable use of needed products in civilian and military emergencies, United States. Emerging Infectious Diseases (EID). 2007;13(7). Available at: http://www.cdc.gov/eid/content/13/7/1046.htm. Accessed July 12, 2007.

- Center for Biosecurity

Contingency Planning