FDA Counters Coronavirus based on the Realities of the Connected World
​[Thursday, March 5, 2020]
World’s response to COVID-19, the flu-like disease caused by the latest strain of coronavirus, highlights key aspects of how we would handle any potential pandemic. Although most of the measures to control the spread, rapid diagnosis, and management of the disease have been taken by the Chinese government where the disease originated and has caused most infections and deaths so far, other countries including the US, have taken measures to limit not only the spread of the disease but also reduce other collateral issues such as the disruption of the supply chains and ongoing regulatory activities. In less than three months since the world found out about the existence of COVID-19, the measures taken by several governments to prevent the spread of the disease have so far avoided a pandemic. Chinese government rapidly quarantined the regions where the infection is known to originate, along with imposing strict travel restrictions to control the spread of the infection. Genetic sequence of the virus and the resulting diagnostic tests were developed in weeks. The Chinese government announced more than 120 clinical trials with potential therapies for COVID-19. FDA announced that it would allow Emergency Use Authorization (EUA) for most COVID-19 diagnostic tests for rapid deployment in the field.  FDA and NIH also announced a clinical trial to evaluate a vaccine for coronavirus. At the same time, FDA has suspended all on-site GMP inspections in China; instead FDA announced that till the travel restrictions to China are lifted, it would rely on import screening, sample testing, a firm’s previous compliance history, and other alternate means to assure that the products imported from China meet the FDA quality requirements. But these are temporary measures. COVID-19, just like flu, is expected to be a seasonal disease which would subside as the temperatures rise in the spring and summer in the northern hemisphere. Theoretically, the disease may spread in the southern hemisphere as it would be winter in those regions but since the spread of the disease is being aggressively controlled, and the epidemiology of the disease in better understood, the probability of a similar spread in other countries a few months hence seems unlikely. Now FDA and other government agencies in the US need to focus on educating the population on sensible measures to prevent the spread of the infection, while controlling the paranoia and anxiety caused by the media hype. The more permanent outcome could be standardization of preventive measures, and incentivization of rapid diagnostic and therapeutic innovation.