Johnson Quoted by Pink Sheet and SmartBrief on FDA’s COVID-19 Medical Products Guidance
Shook Of Counsel John F. Johnson III was quoted by Pink Sheet in the article, “Coronavirus Products Would Get Safe Harbor Under Senate Bill.” The article discusses FDA’s Emergency Use Authorization (EUA) of medical products and the abandoned safe harbor legislative proposal.
EUA was a previously little known power that allows FDA to permit the use of unapproved medical products, or of unapproved uses of medical products, during an emergency if there is evidence that the medical products “may be effective.” This is far lower than the normal approval evidence standard. FDA has been relying on this power to respond to the extraordinary circumstances brought by the COVID-19 pandemic.
In the article, Johnson discusses why a proposed safe harbor that would have allowed manufacturers to share “competent and reliable scientific information” outside of the scope of FDA’s EUA would be something manufacturers may decide they don’t want to use.
Based on Johnson’s previous experience working on EUA before the coronavirus, the article quoted from John’s FDLI presentation about the practical considerations for importing products or components subject to an EUA (much of the medical products supply chain is dependent on imports), noting the authorization is just the first step.
Johnson was also quoted by SmartBrief in the article, “FDA Takes Steps to Speed Diagnostics, Provide Regulatory Relief Amid Pandemic.”