On February 4, 2020, FDA issued a press release regarding the issuance of an emergency use authorization (EUA) (here) to allow for emergency use of a Coronavirus diagnostic panel by Centers for Disease Control and Prevention (CDC)-qualified labs across the country. Previously, the panel’s use was limited to only CDC laboratories. This additional step by FDA to assist ongoing efforts to control the Coronavirus outbreak reinforces the seriousness of the Coronavirus problem. As we’ve seen extensively covered in the news, the Coronavirus outbreak continues to spread, causing severe respiratory illness in humans. In an attempt to contain the spread of the virus, China has implemented extensive travel bans – including grounding flights and trains, and closure of roads. The CDC also issued a Level 3 Travel Health Notice, recommending that travelers avoid all nonessential travel to all of China.
Because the outbreak’s origin has been linked to Wuhan, China, US health officials feel that the threat to the US population, in general, is low. However, in this age of globalization, infectious diseases can spread very quickly, so FDA’s cautionary steps are justified. Also, FDA may have another interest in working on this issue, which is the impact this outbreak is expected to have on drug supply in general, as many parts of the drug supply chain go through China
It has yet to be seen how the transportation restrictions caused by the outbreak will affect pharmaceutical supply worldwide. However, China is the world’s largest producer and worldwide distributor of active pharmaceutical ingredients (API) and excipients. The total impact of this ban will likely not be seen for months ahead, as distributors work through current stock on hand, and it is unclear and debated what level of shortage will be seen – minor disruption unseen to end user, or full-on shortage? In the meantime, we hold our breath and wait for a vaccine to save the world from Coronavirus and drug shortages. We will keep you apprised of the effect that this current public health crisis could have on our drug supply.