On FDA buildings as virtual mailboxes to project the public illusion of biological product manufacturing regulation.
Part 9 of series.
Orientation for new readers - American Domestic Bioterrorism Program - Tools for dismantling kill box anti-law
A Bailiwick reader is doing a deep research dive into pre-1972 statutory and regulatory history of some Public Health Service-Health and Human Services divisions, including National Institutes of Health (NIH) and Food and Drug Administration (FDA).
For context, 1972 is the year that ostensible biologics regulation — which is actually non-regulation — transferred from the NIH Division of Biologics Standards to the FDA Bureau of Biologics.
November 1973 is when FDA published a consolidated set of biological product manufacturing non-regulations in the Federal Register.
Administrative rule-making by FDA since 1973 is relatively easy to locate.
Administrative rule-making by NIH prior to 1973 is more difficult to locate.
One of the questions the reader is trying to answer has to do with whether biological regulation authority was ever statutorily established by Congress, for NIH and its precursor organizations, going back to the late 1800s.
Modern-day NIH and FDA officials present historical accounts of how the biological product and vaccine manufacturing regulatory systems began and developed.
But from her research so far, the reader has concluded that their origin-story claims are not supported by the text of the statutes they cite.
During an email exchange recently, she raised the question “Why are they lying” about their statutory and/or administrative origins?
I sent her a reply with my hypothesis about why NIH and FDA lie about their origins and evolution.
…The "why they are lying" question is one that I've been mulling for a few months.
My hypothesis is that they have maintained a bunch of empty office buildings that serve only as mailing addresses (virtual mailboxes), without having any actual technical staff, laboratory equipment, or application and sample processing procedures.
They do that so that they can have fake forms for vaccine manufacturers to fill out. These included both the establishment license application, ELA, and product license application, PLA, from 1973 to the mid-1990s.
The ELA+PLA application process became, in the mid-1990s, the biologics license application, or BLA, by eliminating even the ostensible/fake requirement for establishment inspections and licensing, and by breaking up the "responsible head" at the factories, into multiple responsible people, so that no one would be responsible.
The factory employees, who are also just a handful of paper pushers with no scientific knowledge or responsibility, in a building whose equipment just makes immunotoxic junk and puts it in vials and slaps labels on it, filled out the application forms and mailed them to the FDA addresses (Bureau of Biologics in 1973, all its NIH predecessors and FDA successors, Center for Biologics Evaluation and Research-CBER now).
The application forms arrived at that address where another one or two paper pushers put them in a filing cabinet and then shredded them a few years later.
Since the advent of electronic filing systems, the application and licensing forms have been filed, transferred and stored electronically, and deleted at regular intervals.
There are no technicians in the buildings, there's no equipment, no sample testing occurs.
It's all a front: statutes, regulations, procedures, application forms, buildings, addresses, offices, labs, approved applications and licenses sent by FDA back to the factories, everything.
A handful of people at pharma companies know it.
A handful of people at FDA know it.
And everyone else just assumes that a different, specialized department with specialized staff, equipment and procedures, is handling it somewhere in the factory, and somewhere within FDA.
Nov. 1995 - Clinton-Gore National Performance Review, Reinventing the Regulation of Drugs Made from Biotechnology:
Revision of the Requirements for a Responsible Head for Biological Establishments
Background: Manufacturers of biological products are required to name a "Responsible Head" who is to exercise control of the manufacturing establishment in all matters relating to compliance with the regulations and who is to represent the manufacturer in all dealings with FDA. This individual must have an understanding of the scientific principles and techniques related to the manufacture of biological products…
Today, however, manufacturers of biological products tend to be larger firms with more manufacturing locations and more complex corporate structures. Most companies do not have one person with the knowledge to represent a company in all matters, but instead have several people with expertise in regulatory affairs, manufacturing, and medical issues…
FDA proposes to revise its requirements for a "Responsible Head" to allow more flexibility to assign control and oversight responsibility within a company…
Firms will be able to divide management responsibility among appropriate regulatory, medical, or manufacturing staff…
Documents
1973.11.20 38 FR 32048 FDA Biological product regulation baseline 21 CFR 600 to 680 42 USC 262
1997.01.29 62 FR 4221 HHS FDA Proposed Rule Responsible head biologic 21 CFR 600.10
1997.10.15 62 FR 53536 HHS FDA Final Rule Responsible head biologic 21 CFR 600.10
1999.10.20 64 FR 56441 HHS-FDA Final Rule eliminate ELA, replace PLA with BLA 21 CFR 601
Series so far
March 8, 2024 - Part 1: Mutual Recognition Agreements. First in series on legal links connecting domestic and international non-regulation of non-medicines
March 12, 2024 - Part 2: Statutory and regulatory definitions for drugs, biological products, and biosimilars
March 15, 2024 - Part 3: Deregulation of biological product manufacturing, mid-1990s to present
March 20, 2024 - Part 4: Vaccines have always been heterogeneous mixtures of toxins used to intentionally sicken people and animals
March 21, 2024 - Part 5: Vaccine and related biological product manufacturing as US government-licensed poison manufacturing Evidence from November 1986 'mandate for safer childhood vaccines' codified at 42 USC 300aa-27, and July 2018 stipulation by HHS.
April 3, 2024 - Part 6: On why FDA revised written non-rules for non-regulation of biological products to make them more unintelligible, inapplicable and unenforceable since the 1990s.
April 25, 2024 - Part 7: Terms, phrases and organizations involved in worldwide regulatory and manufacturing deception surrounding vaccines and other biological products.
May 21, 2024 - Part 8: There is no legal limit to the amount of so-called contamination that can legally be included in vaccines or any other biological products.
