With Coronavirus deaths now over 1,000, the US Food and Drug Administration (“FDA”) announced actions to advance the development of countermeasures directed to the emerging public health threat posed by the novel coronavirus, 2019-nCoV. The FDA noted in their announcement that they are collaborating with other federal agencies and global regulators, as well as product developers and international partners, to “expedite the development and availability of medical products needed to diagnose, treat, mitigate and prevent” outbreaks.
Specifically, the FDA is taking the following steps:
The agency is sharing updates on processes to help developers understand the relevant regulatory pathways, including Emergency Use Authorization (“EUA”), that may assist in rapidly advancing medical countermeasures to the coronavirus, including for example, diagnostic tests.
The agency is issuing key information to the public to help support the timely development of medical products. This information is available on a special landing page, which is available here.
The agency highlighted its Pre-IND Consultation program, and encouraged sponsors developing therapeutics directed to the coronavirus to submit information and questions to that program.
The agency encouraged diagnostic test sponsors interested in the EUA pathway for such tests to contact the agency directly for templates and further information.
Regarding this last concern, the FDA noted that “[b]eing able to quickly and accurately diagnose patients infected with the novel coronavirus is an essential step in helping patients identify the need for care and mitigate the spread of the virus to additional individuals.” However, there are currently no commercially available products to detect the coronavirus. The FDA added that it is “actively working to facilitate the development and availability” of such diagnostics, and that it is “working with public health partners to advance and share the reference materials necessary to facilitate diagnostic development.”
FDA Commissioner Stephen Hahn, MD, noted that the FDA has “a vital mission to protect and promote public health and … [is] actively leveraging the vast breadth of the FDA’s expertise and have begun employing the full range of [the FDA’s] public health authorities to facilitate the development and availability of investigational medical products to help address this urgent public health situation.”
The urgent need for a diagnostic test to combat the spread of the coronavirus is highlighted by comments of former FDA Commissioner Scott Gottlieb, MD, who noted “[a]ccruing date suggests [the virus] is far more contagious, but perhaps less virulent for most victims, than first surmised. It’s possible actual global disease burden is in the many hundreds of thousands and severe cases are a smaller fraction of a big total prevalence.”
The CDC shipped about 200 test kits to be distributed to U.S. domestic laboratories and a similar amount will be distributed to select international laboratories. Each test kit can test approximately 700 to 800 patient specimens. The test kits plus the FDA focus on this emerging health threat will greatly help if the virus becomes wider spread in the US.
In an effort to educate healthcare providers on the coronavirus, this Friday February 14th, at 1pm Eastern, MedChi the Maryland Medical Society and Rockpointe will host a live webinar on the Coronavirus for healthcare professionals. The webinar is free and open to all health professionals, you can register here.