Monkeypox Emergency Authorization (EUA)
On August 9, 2022, the Secretary of the Department of Health and Human Services (HHS) made a determination that there was a public health emergency or a significant potential for a public health emergency that involved the monkeypox virus, which could affect national security or the health and security of United States citizens living abroad. This determination was made pursuant to section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act, which provides the HHS Secretary with the authority to declare a public health emergency and take action to address it.
Monkeypox is a rare disease caused by the monkeypox virus, which is similar to the human smallpox virus. The virus is primarily found in central and West African countries and is typically transmitted to humans through contact with infected animals. While the virus is usually not fatal, it can cause serious illness and complications in some individuals, particularly those with weakened immune systems.
Following the determination of a public health emergency, on September 7, 2022, the HHS Secretary declared that circumstances existed justifying the authorization of emergency use of in vitro diagnostics for the detection and/or diagnosis of monkeypox virus infection, including in vitro diagnostics that detect and/or diagnose infection with non-variola Orthopoxvirus. This authorization was made under section 564 of the FD&C Act, subject to the terms of any authorization issued under that section.
The emergency use authorization (EUA) for in vitro diagnostics provides a pathway for the rapid deployment of diagnostic tests to help identify cases of monkeypox virus infection. This is especially important in the context of a public health emergency, as early detection and diagnosis can help to prevent the spread of the virus and improve patient outcomes. The EUA allows for the use of tests that have not yet received full approval from the U.S. Food and Drug Administration (FDA), provided that they meet certain criteria for safety and effectiveness.
The EUA for in vitro diagnostics is an important tool in the fight against the monkeypox virus, and it highlights the importance of preparedness and response planning for emerging infectious diseases. While rare, outbreaks of monkeypox have occurred in the past, and it is important for public health officials to be able to quickly respond to such outbreaks in order to protect the health and safety of the public.
In conclusion, the HHS Secretary’s determination of a public health emergency involving the monkeypox virus and the subsequent authorization of emergency use of in vitro diagnostics for its detection and/or diagnosis underscores the critical role of public health preparedness and response planning in addressing emerging infectious diseases. By quickly mobilizing resources and deploying diagnostic tools, public health officials can work to prevent the spread of infectious diseases and protect the health and well-being of the public.
To read more about the Moneypox (mpox) EUA please visit the FDA website here