FDA Has Stopped Accepting Covid Related EUAs, It Seems.
(Thursday, March 10, 2022)
Even though the US government has not officially withdrawn the Declaration of Public Health Emergency (PHE) related to Covid from February 2020, there are multiple reports that FDA is not accepting any new Emergency Use Authorization (EUA) applications for diagnostic products under that Emergency. Typically, such rejections from the FDA come with a suggestion to file De novo 510k applications instead of the EUA. While the advice may be practical since the 510k process is much better defined than the EUAs, the rejection of the EUA submissions still comes as a rude shock to the applicants who are following the presumably still active program under the PHE. There has been no formal announcement of the new policy. The last EUA authorized by the FDA was last November. FDA has been signaling for a few months that it wants to move beyond the EUAs. In December last year FDA released two draft Guidance Documents describing the process for de-authorizing EUAs by asking the manufacturers to either withdraw their tests from the market or file 510k applications for the same. But the Guidance Documents state that the until the end of the PHE, FDA will continue to accept and review EUAs. FDA has often been accused of being non-transparent and subjective in its decisions. FDA officials worked hard for the last two decades to dispel that impression of the Agency by creating a robust website containing detailed descriptions of internal processes, releasing several hundred Guidance Documents, making numerous public presentations, engaging directly with stakeholders, creating multiple processes to meet and discuss with FDA review teams, and having its top officials directly interact with the public and industry via social media and public speeches, among other things. However, FDA’s response to the pandemic exposed a still vulnerable agency that is not designed to make quick decisions. Throughout the pandemic, FDA was playing catch-up with other countries in its countermeasures to the virus particularly in diagnostics. The US was far behind other countries in wide adoption of rapid diagnostics, home tests, and public screening. The EUA process for diagnostics was painfully slow and opaque. Many applications did not even get reviewers assigned to them for weeks and months and then rushed through reviews with changing requirements. Even Covid vaccines were approved in other countries first. While one can argue that FDA has one of the most strenuous criteria for product approval, what was missing was the practical approaches to modify the conventional process for a pandemic that killed tens of thousands of patients every day at its peak. The arbitrariness of the EUA acceptance process further stains the reputation of an Agency already tainted by its response to the biggest health emergency in the history of the mankind. FDA should be held accountable for not following its own process. The challenge is that most applicants fear alienating the very Agency they desire to give favorable responses to their applications. So, even when an applicant may believe they have been treated unfairly, they try to work behind the scenes. Thus, many of FDA’s subjective decisions are hidden from the public. There is need for a watchdog who can shine the sunshine on such interactions for an objective regulatory review process that is fair, transparent, balanced, and unambiguous.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC