For the second time in as many months, US regulators have leveraged new authority granted to them under recently-passed anti-bioterrorism legislation that allows them to approve products based on an understanding that an emerging virus could become a threat to public health. This time, however, the emerging virus is far different than the typical strains of influenza public health officials usually grapple with.
In March 2013, the US Food and Drug Administration (FDA) was given a host of new authorities and responsibilities under the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), a piece of legislation meant to bolster the government's ability to respond to health crises, and especially those of a biological nature.
Among the law's many provisions is one that allows FDA to temporarily approve a medical product if it determines that an emergency is likely to occur-a "threat justifying emergency authorized use," to quote the legislation. The law also allows FDA to approve those products without first ensuring that they meet current good manufacturing practice (CGMP) regulations.
The bill was signed into law on 4 March 2013 by President Barack Obama, and received overwhelming bipartisan support during its passage through Congress.
A little more than a month later, FDA issued an order finding that an emerging strain of the influenza virus (H7N9) represented a "significant potential for a public health emergency," clearing the way for the subsequent emergency use approval (EUA) of the Center for Disease Control and Prevention's (CDC) Human Influenza Virus Real-Time RT-PCR Diagnostic Panel-Influenza A/H7 (Eurasian Lineage) Assay on 22 April 2013.
At the time of FDA's Federal Register posting on H7N9, CDC hinted at further products coming down the pipeline as well.
"The Centers for Disease Control and Prevention (CDC), HHS, requested that the FDA … issue an emergency use application (EUA) for in vitro diagnostics for detection of the avian influenza A (H7N9) virus to allow the Department to take preparedness measures based on information currently available about the avian influenza A (H7N9) virus detected in China," DHHS wrote. The key word there being diagnostics-plural, not singular.
New Virus, New Authority, New Device
Sure enough, FDA has now quietly approved its second Emergency Use Application of the year-but in a twist, not for the H7N9 virus.
Instead, the new approval follows a Federal Register posting on 5 June 2013 in which the US Department of Health and Human Services (DHHS) declared that a second virus, the Middle East Respiratory Syndrome Coronavirus (MERS-CoV), again represents a "significant potential to affect national security or the health and security of US citizens living abroad."
The virus, about which little is known, has already been detected in several countries by public health officials who have expressed alarm at its high fatality rate and unknown origins. But US public health officials again seem to be moving quickly to stay ahead of the virus, with FDA approving a real-time RT-PCR assay made by CDC to assist healthcare providers in detecting MERS-CoV.
"The CDC Novel Coronavirus 2012 Real-time RT-PCR Assay is a real-time reverse transcriptase PCR (rRT-PCR) for the in vitro qualitative detection of MERS-CoV viral RNA from respiratory specimens (such as nasopharyngeal or oropharyngeal swabs, sputa, lower respiratory aspirates/washes), sera, and stool from patients with signs and symptoms of MERS-CoV infection in conjunction with clinical and epidemiological risk factors," FDA explained in its EUA letter to CDC Director Thomas Frieden. "The testing procedure consists of nucleic acid extraction followed by rRT-PCR on the FDA cleared Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument."
FDA said it would also be waiving CGMP requirements for the device under 21 CFR 820, as well as labeling requirements under 21 CFR 809.10 and 809.30.
FDA: Emergency Use Authorizations Page
Federal Register Notice