The FDA has no shortage of regulatory terms. In fact, they are awash with them to the point of exhaustion. But there is one term that I haven’t been able to find, “BLA Compliant.”
This won’t make sense if you don’t know what BLA means, so allow me. BLA is an acronym for Biologics Licensing Application. This is the application a drug company submits when it is seeking full FDA approval for their drug. Pretty basic, so let’s move on.
The applications are pretty dull, a lot of clinical data to show the efficacy of the product etc etc, but there are two aspects of the application that are also approved by FDA and required by the drug manufacturer. Those two things are: manufacturing locations and labeling requirements. Some of this was touched on previously about licensure. See Part 1.
In fact, it’s such an important part of the licensure process it is specifically addressed in the approval letter.
Under content of labeling it states, “Content of labeling must be identical to the Package Insert submitted on August 21, 2021.”
So here is what that Package Insert label submission looked like. Thanks B.
All license labeling requirements met. Proprietary name, license number, expiration date and manufacturer info. Check check check and check. (Don’t worry, I am getting to why this is important.)
We haven’t seen any of these labeled products (we will get to why in some later posts) but what we got instead was a Dear Healthcare Provider letter from Pfizer about the mysterious regulatory term “BLA Compliant” lots.
The letter and corresponding lots.
There are some interesting words in this letter, and a lot of deception. The letter is basically saying to the healthcare professionals “you just ignore those labels and treat them “as if” they are licensed.” Did anyone else get the Terry Adirim shivers? That was rough. Anyway, I am still just trying to figure out how an improperly labeled product can meet the terms of the BLA when the BLA specifically has a labeling requirement. That makes absolutely no sense. Maybe it is even illegal.
But despite this, the DoD has contended in the court (one of their many vaccine lawsuits) that they are only mandating these BLA compliant lots. Kinda strange though, I do not remember seeing anything about that in Adirim’s memo. No mention of BLA compliant lots anywhere, no publicly available policy to remedy this confusion. It is almost as though this became a convenient excuse for when the mandates began to be challenged.
Now I could tell you that 7 of these 9 lots (that retain EUA labels inexplicably) were manufactured before the approval, that for legal purposes all 9 cannot be mandated, that I know for a fact that each of these lots is associated with emergency use National Directory Code (NDC) and are legally designated as EUA products. Sure, that’s all true. But what I think is really important, is that the FDA are big fat law breakers and any misrepresentation to imply approval of an unapproved product is a violation of Title 21 Sec 207.37.
Alright, so what we know now is that BLA compliant is a made term. The FDA is violating the law, as far as I can tell, and the DoD is not off the hook because Judge Allen Winsor has already made a judgement on November 12, 2021 that any EUA labeled vaccine cannot be mandated. Yet, DoD persists.
So tomorrow, I don’t know yet. Maybe see what the Defense Health Agency thinks. Maybe explore what legally distinct means.
The world is my oyster bay.