Dear Readers,
This is the podcast recording that Substack would not let me cross-post from Cornelia’s page. She has written about this in the article that I was able to cross post yesterday. Which tells me, someone at Substack is minding my newsletter very closely. Substack has cut off all the growth for my page for over 12 months now, however, this particular selective “feature” is new. This type of censorship is very sophisticated and technically difficult to implement.
Not to worry, censorship won’t stop me, and I thank all of you who support this newsletter!
I received some questions regarding the material I previously published about biologics non-regulation, and how it squares with the CHD Citizen Petition which asks the FDA to revoke BLA licenses for Pfizer and Moderna covid shots because they did not satisfy the BLA standards.
This is a very confusing issue (on purpose, I assure you). There are several categories of law and regulations that apply, don’t apply or sometimes apply to “biologics” and “vaccines”. I tried to make a simplified and highly generalized graphic for two major categories of regulations/law that we are concerned with:
Regulation of the composition-of-matter for a given medicinal product: this is where we are concerned with precision of ingredients, contaminants, i.e. - all cGMP regs.
Regulation of informed consent and protection of human subjects in investigational clinical research, which are pre-requisites to “FDA approval” of anything. These rules are entirely suspended under CBRN “emergencies” declared via the PREP Act.
As you can see, the EUA Countermeasures is an extremely attractive space, because no pharmaceutical regulations apply whatsoever for the duration of the PREP Act declaration of emergency! The PREP Act has proven to be a nearly impenetrable liability shield based on the now accumulated case law. The CHD petition is primarily focused on the FDA falsely claiming that studies conducted by Pfizer and Moderna while on the non-investigational EUA pathway, can satisfy the legal requirements of the investigational biologics approval pathway. I.e., we are talking about the difference between the upper 2 quadrants of this graph.
Hope this helps you to navigate this discussion.
Art for today: Lilac and Tulips, oil on panel, 12x16 in.
