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Regulatory News | 20 June 2014 | By Alexander Gaffney, RAC
Citing continued risks to human health, the US Food and Drug Administration (FDA) has once again granted market access for an in vitro diagnostic device meant to detect the H7N9 influenza virus, using its emergency authority under a little-known law.
In March 2013, 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.
Since then, FDA has approved at least three other products for the H7N9 virus:
Now, though, FDA has announced two additional approvals.
In a Federal Registerposting on 20 June 2014, FDA announced the approval of Arbor Vita Corporation's A/H7N9 Influenza Rapid Test, saying that the agency believed that the test's benefits would "outweigh the known and potential risks" of its use based on the "totality of scientific evidence available to FDA."
The approval had been made on 25 April 2014, FDA said.
A review of FDA's website also revealed that FDA recently reapproved a device made by CDC known as the Novel Coronavirus 2012 Real-time RT-PCR Assay. That device, first approved in July 2013, is intended to detect the presence of the Middle East Respiratory Syndrome Coronavirus (MERS-CoV), a virus thought to have originated in camels that has been spreading throughout the Middle East in recent months.
FDA said the CDC had submitted an amendment to the original application on 22 May 2014, and that FDA had approved it on 10 June 2014—just 19 days later.
While all applications are given special regulatory privileges, such as an exemption from current good manufacturing practices under 21 CFR 820, they are also subject to strict marketing restrictions. The products must be distributed with a specific fact sheet for healthcare providers, another for patients, and unique labeling meant to convey its limited approval. In addition, products must only be sold to "qualified laboratories," usually defined as CLIA High Complexity Laboratories or foreign laboratories.
Federal Register Notice
Tags: Emergency Use Authorization, H7N9, Emergency Use, Assay, Emergency Use Approval, PAHPRA