We recently examined the National Institutes for Health’s (NIH) failure to fund research into repurposable therapeutics during the pandemic in a TrialSite article “COVID-19 Pandemic: What Have We Learned about Effective Responses to Save Lives?”
We felt it fitting to check in with another member of the Alphabet Soup Gang to see what they are actively doing to address the current national crisis. As cases increase exponentially, essential services are grinding to a halt, hospitalizations are surging while staff shortages are choking the ability to provide care, and while the hospital staff is being advised to work with covid in some states, it’s been frustrating to see little to no help coming from the FDA. The questionable EUA for molnupiravir is just the latest example of their concerning actions and inaction, as we covered here.
However, yesterday, it became clear that the FDA has been engrossed in leveraging their regulatory powers that led to their issuance of the landmark rule that will no doubt improve the health and wellbeing of all Americans.
Lest you think that this was a simple regulatory rule change requiring minimal effort, it’s been in the works for years by our ever-diligent top national health regulatory agency. In late December 2020, when the pandemic’s most deadly surge was raging, the FDA submitted this detailed rule change proposal. Subscribe to the Trialsitenews “Vaccine” ChannelNo spam – we promise
Now seeing what critical matters the FDA was dedicated to leading up to this filing, it’s clear why they didn’t have the time or resources to perform other lower priority tasks, such as inspecting the four Ventavia trial sites that were reported for shocking quality control issues by an internal employee. Remember this is the whistleblower working for a contract research organization (CRO) serving the Pfizer COVID-19 vaccine clinical trial. Evidence was provided by the employee directly to the FDA via a formal complaint.
Despite being handed the smoking gun on a silver platter, the FDA was clearly working on more pressing matters at the time, such as the revocation of the standard identity for French dressing.