Legalized FDA non-regulation of biological products effective May 2, 2019, by Federal Register Final Rule, signed by then-FDA Commissioner Scott Gottlieb.

Katherine Watt

Dec 19

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Orientation for new readers.

Related Sage Hana reporting and analysis.

Dec. 18, 2023 - Brook Jackson's November, 2021 Whistleblowing BMJ Article Reprinted (Sage Hana)

NOTE: Brook Jackson’s litigation is related to legalized FDA non-regulation of clinical trials. The information below is related to legalized FDA non-regulation of biological product manufacturing.

Legal paper trail documents are provided after the text for readers interested in digging deeper.

Under the 1944 Public Health Service Act, biological products were defined as “any virus, therapeutic serum, toxin, antitoxin, or analogous product, or arsphenamine or its derivatives (or any other trivalent organic arsenic compound).”

In 1970, the biological products definition was amended to add, after the word “antitoxin,” several new products, including “vaccine, blood, blood component or derivative, allergenic product."

Until May 2, 2019, FDA inspectors were required to inspect all establishments or facilities producing biological products at least once every two years, and held eight enumerated inspection duties.

The relevant section, 21 CFR 600.22, read:

"The inspector shall:
(a) Call upon the active head of the establishment, stating the object of his visit,
(b) Interrogate the proprietor or other personnel of the establishment as he may deem necessary,
(c) Examine the details of location, construction, equipment and maintenance, including stables, barns, warehouses, manufacturing laboratories, bleeding clinics maintained for the collection of human blood, shipping rooms, record rooms, and any other structure or appliance used in any part of the manufacture of a product,
(d) Investigate as fully as he deems necessary the methods of propagation, processing, testing, storing, dispensing, recording, or other details of manufacture and distribution of each licensed product, or product for which a license has been requested, including observation of these procedures in actual operation,
(e) Obtain and cause to be sent to the Director, Center for Biologics Evaluation and Research or the Director, Center for Drug Evaluation and Research (see mailing addresses in § 600.2(c)), adequate samples for the examination of any product or ingredient used in its manufacture,
(f) Bring to the attention of the manufacturer any fault observed in the course of inspection in location, construction, manufacturing methods, or administration of a licensed establishment which might lead to impairment of a product,
(g) Inspect and copy, as circumstances may require, any records required to be kept pursuant to § 600.12,
(h) Certify as to the condition of the establishment and of the manufacturing methods followed and make recommendations as to action deemed appropriate with respect to any application for license or any license previously issued.

Since May 2, 2019, FDA inspectors have had none of those duties, and are not required to inspect biological product manufacturing facilities at any time intervals.

Prior to the rule change, 21 CFR 600.21, Time of inspection, read:

The inspection of an establishment for which a biologics license application is pending need not be made until the establishment is in operation and is manufacturing the complete product for which a biologics license is desired.
In case the license is denied following inspection for the original license, no reinspection need be made until assurance has been received that the faulty conditions which were the basis of the denial have been corrected. An inspection of each licensed establishment and its additional location(s) shall be made at least once every 2 years. Inspections may be made with or without notice, and shall be made during regular business hours unless otherwise directed.

Effective May 2, 2019, the last three sentences of 21 CFR 600.21 were removed.

There is currently no legal requirement for an initial FDA inspection; no minimum interval for subsequent FDA inspections, and no legal consequences for compliance failures, such as establishment or product license denial or revocation.

The legal mechanism through which FDA regulation of biological product manufacturing disappeared, included a Direct Final Rule and a Proposed Rule, simultaneously issued by Federal Register notice on Feb. 26, 2018, and an April 2, 2019 Final Rule, issued by then-FDA Commissioner Scott Gottlieb.

To summarize: On April 2, 2019, effective May 2, 2019, FDA Commissioner Scott Gottlieb changed the federal regulations governing inspection of licensed facilities manufacturing biological products including ‘vaccines’, from at least every two years to unspecified times; eliminated provisions about what would happen if a licensed facility failed an inspection; and eliminated all inspection duties for FDA inspectors.

A commenter submitted a pithy comment in response to the Feb. 26, 2018 notices, reprinted in the Final Rule document published in the Federal Register April 2, 2019:

"One comment expressed concern that the risk-based inspection frequency will not be without negative health consequences.
The comment also stated that ‘‘[R]isk Management is an identified known weak element to a majority of biological and medical device companies’’ and that the management and mitigation of risk without FDA oversight for a number of years is going to be a high-risk endeavor…"

Indeed.

Related Bailiwick reporting and analysis:

Oct. 21, 2022 - Legal horror movie pitch: The World According to Darp. 'Shouting fire in a crowded theater' meets 'When did you stop beating your wife?' “…The villain is Darpon Fink, an ugly, awkward, reclusive middle-aged serial killer/arsonist. Darpon gets a job as a building inspector in a mid-sized American city. His first day on the job, he repeals all the building safety codes. His second day on the job, he lobotomizes city council members, police officers, firefighters, prosecutors and judges, and then gasses them with paralytics. They sit in their usual chairs, at their usual desks in their City Hall offices. But they can’t move or speak. His third day on the job — the day a popular musician is scheduled to perform in the city’s largest theater — Darp removes the smoke detectors and sprinklers in the theater and barricades from the outside all but one door…”
Dec. 19, 2022 - Biomedical security state and state-run bioterrorism programs: six American statutory frameworks. (Memo prepared for Sen. Ron Johnson, at his request.) “…Through the pioneering work of the Informed Consent Action Network (ICAN) and Children's Health Defense (CHD), culminating in a July 9, 2018 stipulation, [signed by Robert F. Kennedy Jr.] Americans have learned that those oversight functions have never been performed by US Government officials, and none of the currently-available "vaccines" produced by or for American pharmaceutical companies and administered to children and adults in the United States and around the world, can be conclusively demonstrated to be safe or effective. It is now more widely understood that federally-directed production and use of the toxic bioagents known as "vaccines" to injure, sicken and kill Americans, and provide liability exemption for sponsors, pharmaceutical manufacturers and vaccinators, has been domestic and international policy and practice since 1986…”
April 13, 2023 - Vaccine production facilities are indistinguishable from bioweapon production facilities, and vaccines are indistinguishable from bioweapons. “…At the third review conference of the BWC in 1991, several countries tried to launch a formal negotiation to bolster the treaty with a legally binding verification regime, but they failed to achieve consensus. The George H. W. Bush administration argued that verification was not possible with any degree of confidence because of the dual-use nature of biotechnological materials and equipment, which makes it easy to divert legitimate facilities such as vaccine plants to illicit production…Advances in fermentation technology have also eliminated the need to stockpile biowarfare agents. Instead, a legitimate production facility, such as a vaccine plant, could be commandeered to grow seed cultures into militarily significant quantities of agent within a period of weeks. Given these technical realities, the detection of illicit biological weapons activities poses daunting challenges for any conceivable monitoring regime…”
Oct. 28, 2023 - Whatever is in the biochemical weapons bearing Pfizer and other pharma labels, is there because US SecDefs and their WHO-BIS handlers ordered it to be there. “…What Malone, Steve Kirsch and other DoD spokesmen are doing is a distraction maneuver to keep attention away from the intentional toxicity of the biochemical weapons, the DoD/WHO control of the programs, and the fact that “biodefense” is camouflage for straight-up State-sponsored biowarfare, conducted by bringing pharmaceutical companies into the military-industrial-Congressional complex, calling bioweapons “vaccines,” and terrifying people into taking them under “public health emergency” and “pandemic” narratives…”

Documents related to legalized FDA non-regulation of biological product manufacturing, including but not limited to vaccines; Public Health Service Act Section 351; 42 USC 262; 21 CFR 600 et seq.; presidential executive orders on regulatory reform; more.