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FDA Using New Legal Preparedness Authority to Combat Potential MERS / H7N9 Threats

posted on Wed, Aug 14 2013 3:48 pm by Daniel G. Orenstein

Over the past several months, considerable public health (and popular media) attention has focused on H7N9 influenza and Middle East respiratory syndrome coronavirus (MERS/MERS-CoV). The Food and Drug Administration (FDA), acting under legal authority recently bolstered by the Pandemic and All Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), moved decisively to facilitate preparedness by issuing Emergency Use Authorizations (EUAs) for diagnostic tests for both viruses. EUAs allow the FDA to temporarily approve medical products such as antibiotics, vaccines, and diagnostic tests needed during emergencies. Should either virus become a significant domestic public health threat, EUAs provide an advance legal tool to address their impacts.

H7N9 is a novel form of avian influenza—similar to H5N1, among others—that was first reported in China in April 2013 and has thus far not spread internationally. The number of new cases fell abruptly this summer, potentially due to effective containment measures or rising temperatures. However, the virus could reemerge in the fall, consistent with a pattern seen in other avian influenzas.

MERS is a coronavirus—the same type implicated in the 2003 SARS outbreak—that was first reported in Saudi Arabia in 2012. There have been less than 100 confirmed cases (all linked to the Arabian Peninsula), but over half have been fatal.

There is concern of a global increase in infections following the upcoming annual Hajj pilgrimage, which will bring millions of Muslims to Mecca, Saudi Arabia. The CDC is not currently advising changes in travel for Americans planning to attend. The World Health Organization is similarly recommending only general travel health precautions, as there has been no sustained human-to-human transmission. Yet Saudi authorities have limited the number of persons allowed to attend this year and urged those who may be at increased risk of illness or serious negative outcomes—including the elderly, chronically ill, children, and pregnant women—not to participate.

There have been no reported cases of H7N9 or MERS in the U.S., and neither has emerged as a global pandemic. However, the mortality rates, pandemic potential, and historical echoes of the two viruses are concerning. There is currently no FDA-approved test or treatment for either virus. In response, FDA has taken early precautionary measures, issuing EUAs for diagnostic tests for both viruses. EUAs allow either the use of unapproved drugs or medical devices, or unapproved uses of approved drugs or devices. The Project Bioshield Act of 2004 empowers FDA to issue EUAs in response to public health emergencies declared by the Secretary of Health and Human Services. PAHPRA further clarified a critical aspect of this authority, specifically authorizing FDA to issue EUAs prior to a formal declaration of public health emergency if there is significant potential that a CBRN agent will affect national security or the health and security of U.S. citizens abroad.  Among many advantages, issuing EUAs earlier provides stakeholders with more time to prepare for an emergency and improves the capability to monitor safety and effectiveness of emergency usage. PAHPRA’s specific statutory authority improves responsiveness and reduces the potential for conflict.

Prior to PAHPRA, EUAs had been issued only regarding H1N1 influenza (2009-2010) and Anthrax (2005 and 2008). One Anthrax-related EUA, concerning post-exposure prophylactic antibiotics, remains in effect, but all others have been terminated.

Issuance of EUAs related to H7N9 and MERS prior to any reported U.S. cases indicates the seriousness with which FDA regards their pandemic potential. It also illustrates the flexibility and adaptability of FDA authority as clarified under PAHPRA. As epidemiologic research develops further on these viruses, FDA will be able to respond quickly, hopefully mitigating the impact on population health.

This blog post was developed by Daniel G. Orenstein, J.D., deputy director, Network for Public Health Law – Western Region at the Sandra Day O’Connor College of Law, Arizona State University.

The Network for Public Health Law provides information and technical assistance on issues related to public health. The legal information and assistance provided in this document does not constitute legal advice or legal representation. For legal advice, readers should consult a lawyer in their state. This blog post does not represent the views of the Robert Wood Johnson Foundation.

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