Background
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.
Second Approval
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 is diagnostics—plural, not singular.
Later on that year, FDA approved a second application based on an EUA, this time for an assay intended to detect the presence of the Middle East Respiratory Syndrome Coronavirus (MERS-CoV), another virus which officials said represented a “significant potential to affect national security or the health and security of US citizens living abroad.” The device, known as the Real-Time RT-PCR Assay, was also developed by the CDC.
New: Third Approval
Now FDA has announced a third EUA for yet another H7N9 influenza assay, representing the diagnostic test developed outside government laboratories to be given an EUA approval. Quidel Corporation’s Lyra Influenza A Subtype H7N9 Assay was given FDA authorization on 14 February 2014 based on the same public health threat assessment identified in April 2013. “Based on the totality of scientific evidence available to FDA, it is reasonable to believe that the Lyra Influenza A Subtype H7N9 Assay used on the specified instruments may be effective in diagnosing influenza A (H7N9) virus,” FDA wrote in its letter to Quidel. The assay includes two reagents and two control materials, all of which fall under the approval order.
As with all products subject to emergency approval, FDA’s approval also includes a specific fact sheet for healthcare providers, another for patients, and unique labeling meant to convey its limited approval. cGMP (21 CFR 820) requirements for the assay are also being waived by FDA, the agency wrote. The device will only be allowed to be sold to CLIA High Complexity Laboratories or foreign laboratories, FDA added.
REFERENCE: Regulatory Focus; Alexander Gaffney, RAC; 19 FEB 2014