Recommended Reading: Public Health Law Bolsters FDA’s Pandemic Preparedness
Ahead of the annual pilgrimage of Muslims to Mecca and Medina in Saudi Arabia this October, the Saudi health ministry is limiting the number of foreign and local pilgrims in order to lower the risk of the spread of H7N9, a new form of avian flu identified several months ago in China, and MERS, or Middle East respiratory syndrome corona virus (MERS/MERS-CoV), a potentially fatal virus that emerged last year. The largest numbers of cases of the virus—and deaths—have been in Saudi Arabia. According to a recent post on the Network for Public Health Law’s (NPHL) blog by Daniel G. Orenstein, JD, deputy director of NPHL’s Western Region, so far neither the U.S. Centers for Disease Control and Prevention nor the World Health Organization have issued travel restrictions about the Hajj.
However, the post does note that the emergence of the two viruses has prompted the U.S. Food and Drug Administration (FDA) to take action under its legal authority to increase U.S. readiness to treat potential outbreaks of H7N9 and MERS. Under the Pandemic and All Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), the FDA recently issued Emergency Use Authorizations (EUAs) for diagnostic tests for both viruses. EUAs enable the FDA to temporarily allow use of unapproved medical products such as antibiotics, vaccines and diagnostic tests needed during emergencies.
Orenstein says that “issuing the EUAs 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.”
>>Read more: Read the full post on the Network for Public Health Law’s blog.