Regulatory Focus™ > News Articles > 2020 > 1 > FDA Outlines Product Development Process to Combat Wuhan Coronavirus

FDA Outlines Product Development Process to Combat Wuhan Coronavirus

Posted 28 January 2020 | By Michael Mezher 

FDA Outlines Product Development Process to Combat Wuhan Coronavirus

The US Food and Drug Administration (FDA) on Monday issued a statement explaining how the agency can facilitate the development of investigational products to diagnose, treat and prevent emerging public health threats such as the novel coronavirus (2019-nCoV) that emerged in Wuhan, China in December.
“We are actively leveraging the vast breadth of the FDA’s expertise and have begun employing the full range of our public health authorities to facilitate the development and availability of investigational medical products to address this urgent public health situation,” said FDA Commissioner Stephen Hahn.
As with the Zika and Ebola virus outbreaks in recent years, FDA says it may grant emergency use authorizations (EUA) to medical countermeasures, such as diagnostics and therapeutics under Section 564 of the Federal Food, Drug, and Cosmetic Act.
There are currently no FDA-approved diagnostics, vaccines or drugs for 2019-nCoV, though several drugmakers, including Johnson & Johnson and Inovio Pharmaceuticals, and diagnostics developers have said they are working on vaccines and tests. The National Institutes of Health (NIH) has also partnered with Massachusetts-based biotech company Moderna to develop an RNA vaccine against the virus.
However, before FDA can issue an EUA, either the Department of Defense (DoD), Department of Homeland Security (DHS) or Department of Health and Human Services (HHS) Secretary must issue an emergency or material threat determination. After one of those determinations is made, the HHS Secretary must issue an emergency declaration justifying emergency use of unauthorized products or unapproved uses of authorized products.
On Tuesday, HHS Secretary Alex Azar said he “won’t hesitate at all” to make an emergency declaration but said that the circumstances for a declaration have not been met, noting that there are only five confirmed cases of the virus in the US. Azar’s statement comes a week after the World Health Organization’s Emergency Committee determined that the outbreak so far does not meet the conditions to declare a Public Health Emergency of International Concern (PHEIC).
While FDA cannot currently issue an EUA, the agency directs diagnostics developers to contact the Center for Devices and Radiological Health for information and templates for submitting a pre-EUA and requests that therapeutic sponsors contact the Center for Drug Evaluation and Research’s pre-investigational new drug consultation program.
According to FDA, a pre-EUA “allows FDA scientific and technical subject matter experts to begin a review of information and assist in the development of conditions of authorization, fact sheets, and other documentation that would be needed for an EUA in advance of an emergency and also helps to facilitate complete EUA requests during a current emergency declaration,” but notes that a pre-EUA cannot transition to an EUA without an emergency declaration from the HHS Secretary.


© 2022 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.