A new Federal Register document published by the US Department of Health and Human Services (DHHS) indicates that the US Food and Drug Administration (FDA) is moving to leverage new regulatory authorities that for the first time ever allow it to declare a public health emergency based on a potential, rather than actual, threat. The new authority has already been leveraged once, officials say, based on an emerging strain of the avian flu that has researchers and public health officials concerned.
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.
Quick Use Based on Emerging Flu Threat
Barely more than a month since PAHPRA was signed into law, FDA has already used its newfound authority to approve an emergency use application.
The first product approved by the agency is the Center for Disease Control and Prevention's (CDC) Human Influenza Virus Real-Time RT-PCR Diagnostic Panel-Influenza A/H7 (Eurasian Lineage) Assay, approved on 22 April 2013.
That determination came just three days after FDA Commissioner Margaret Hamburg determined that an emerging strain of an avian flu virus known as H7N9 represents a "significant potential for a public health emergency." That step was necessary to support the emergency approval of the CDC's device.
The agency's 2013 EUA approval letter notes that CDC will be required to track and report adverse events, maintain records of the device's usage, ensure that only qualified facilities use the device, and post information regarding its safe use on its website. The EUA is in effect until it is specifically revoked by FDA.
Further Approvals on the Way?
And, according to the Federal Register, CDC isn't asking for FDA to approve just one device-there are others in 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.
And those further approvals may already be well on their way. The 2009 H1N1 influenza outbreak saw FDA approve 19 products under its EUA authority, including three from the CDC.
Other products are on their way as well, BioCentury reported last week. In an interview between Steve Usdin, editor at BioCentury, and Luciana Borio, assistant commissioner for counter-terrorism policy at FDA, Borio explained that FDA is already working to approve new flu detection devices. Another official, Robin Robinson, director of the Biomedical Advanced Research and Development Authority, added that his agency is also working with private industry to get new treatments-and specifically vaccines-to market as fast as possible. Robinson said he hoped to have a vaccine available by summer 2013.
Federal Register Notice on H7N9