Sen. Rand Paul, FDA Modernization Act 2.0, and animal testing of new drugs.
Part 10 of series.
Orientation for new readers - American Domestic Bioterrorism Program - Tools for dismantling kill box anti-law
Reply to a comment at Sasha Latypova’s latest post, about federal and state quarantine authorities.
June 2, 2024 - Grand Princess Quarantine Orders - Discussion with Dr. Jane Ruby. Partial FOIA response has been obtained from HHS by Children's Health Defense (Sasha Latypova)
“…I wrote previously about the lawsuit filed (and lost/not appealed) by the AGs of 15 states v HHS’s definitions of pandemic here. [Texas, Oklahoma v. HHS case documents] In response to that lawsuit, the HHS stated that they already have the authority to declare pandemics whenever they wish to, and do not need the WHO Pandemic Treaty or IHR Amendments to exercise this power.
The judge also ruled that the states did not have sovereignty on this matter.
In their response to the legal complaint by the AGs, the HHS stated that they already exercised this power in early 2020 by detaining people on false pretenses at several military bases, and killing 10 of them and labeling it “covid”.
Of course, they didn’t word it like that, they said something about “asymptomatic,” “pre-symptomatic,” and “reasonable belief” that of course was based on secret PCR-enabled knowledge about an alleged pandemic virus that only CDC had and nobody could independently verify at the time, nor since, really…
The government, federal or state, can throw you into a facility and murder you any time, calling it Disease X, Y, Z, avian flu, etc. That’s exactly how those CDC orders were written and dispensed for the Grand Princess passengers…
People who were not ill, without any symptoms were designated “pre-communicable” and a “threat” based on some handwaving “rules” that CDC uses and nobody can question or review were kept in detention, until CDC would decide if they can be released. They could appeal - to CDC of course, the same people who put them there! 10 people died as the result of this detention.
Ask the brave freedom warriors Governor DeSantis or AG Paxton or the 49 Republican politicians who signed “Stop the WHO” letter to explain this one to you. Maybe they are interested in signing “Stop the CDC!” letter?”…
It is mine and Katherine’s conclusion that under PHE, CDC Director becomes the judge, jury and executioner. There is no due process and nowhere to appeal to but to the same MD, PhD goons who stuck you into the military prison. Dear freedom movement people, please, come back from Geneva, and let’s start drafting those “Stop the CDC” campaigns asap!…”
Bailiwick reporting and analysis about federal and state quarantine authority at footnote.1
Reader commented at Sasha’s post:
“…If, as we know due to your and Katherine Watt's research that pharma is just a front for DoD EUA countermeasures bioweapon deployment, and if Jerry Hayseed from Upper Buttcrack, Missouri (read: ME!) knows this, HOW IS IT [Rand] Paul isn't addressing this?…And Dr. Naomi Wolf and Dr. Peter McCullough why aren't THEY talking about it?!”
My reply, expanded:
Yes, if you know about it, Rand Paul, Naomi Wolf, Peter McCullough and everyone else not talking about it, also know about it.
Those who don't talk about it, keep silent about it because they serve on the team assigned the job of misdirecting the public away from the DoD-FDA-Pharma complex and the intentionality of the worldwide sterilization and killing program.
Specific to Rand Paul, he sponsored FDA Modernization Act 2.0, passed in Dec. 2022 as part of the Consolidated Appropriations Act (PL 117-328).
Animal testing amendments were covered at Sec. 3209 (136 Stat 5821) and codified as revisions to 21 USC 355(i) and 42 U.S.C. 262(k)(2)(A)(i)(I).
For context, Congress and President Clinton passed the first FDA Modernization Act, PL 105-15, in November 1997, alongside the NDAA for FY1998, setting the legal framework for intentionally toxic, regulation-exempt EUA countermeasures to be deceptively presented to the public as regulated medicinal products, and coercively used.
The December 2022 law, FDA Modernization Act 2.0, sponsored by Sen. Rand Paul and Sen. Cory Booker, addressing what pharmaceutical companies theoretically must do to demonstrate safety of new drugs, eliminated animal testing requirements.
Press Releases issued by Sen. Rand Paul:
Sept. 29, 2022 - Senate passes Paul-Booker bipartisan FDA Modernization Act 2.0, end animal testing mandates… “Last October, Dr. Rand Paul and Sen. Cory Booker introduced the…FDA Modernization Act [2.0], and in the spirit of the bill, Dr. Paul hosted a Puppy Press Conference.
Jan. 6, 2023 - Dr. Paul’s Bipartisan FDA Modernization Act 2.0 to end animal testing mandates included in 2022 year end legislation
Nov. 20, 2023 - Dr. Rand Paul Urges FDA to Update Animal Testing Guidance in Accordance with the FDA Modernization Act 2.0
News report on the FDA Modernization Act 2.0:
Jan. 12, 2023 - The FDA no longer requires all drugs to be tested on animals before human trials (Joe Hernandez, KUOW)
"…Signed by President Biden in December as part of a larger spending package, the law doesn't ban the testing of new drugs on animals outright.
Instead it simply lifts the requirement that pharmaceutical companies use animals to test new drugs before human trials. Companies can still test drugs on animals if they choose to...
There are a slew of other methods that drugmakers employ to assess new medications and treatments, such as computer modeling and "organs on a chip," thumb-sized microchips that can mimic how organs' function are affected by pharmaceuticals…
This year's federal budget also includes $5 million for a new FDA program aimed at reducing animal testing by helping to develop and encourage industry to adopt new product testing methods…"
Keep in mind that FDA is not legally obligated to hold pharmaceutical companies to any safety, efficacy or purity standards for biological products.
Regulations, guidance documents, false nonclinical and clinical trial records, product licensing records, and press conferences are put forward only to deceive the public into thinking that there is a manufacturing regulatory system whose goal is to keep toxic products out of human bodies.
The truth is the opposite: the FDA-Pharma-DoD system's goal is to get toxic products into human bodies.
See also:
January 2023 - NIH-FDA MOU 225-23-003, re: “advancement of Microphysiological Systems.”
Bailiwick series on FDA non-regulation of non-medicines, including vaccines, more accurately understood as intentionally immunotoxic poisons.
Sept. 19, 2022 - In Nov. 2020, Pfizer told FDA reviewers, led by Marion Gruber, that safety studies were neither needed nor conducted. In making that argument, Pfizer cited WHO guidance written in 2002 by a team led by Marion Gruber. - “…At this point in early Summer 2021, four facts became more widely understood among the community of people trying to understand the biotechnology, risks and benefits of the products marketed as Covid-19 vaccines. (1) The inflammatory lipid nanoparticles and their payloads collect in the ovaries and other key organs, are not rapidly cleared from the human body and are toxic; (2) Pfizer scientists knew this before seeking EUA approval from the FDA through the 11/20/2020 EUA application; (3) FDA scientists led by Marion Gruber knew this when authorizing the product for emergency use on 12/11/2020; (4) Pfizer, FDA and Gruber withheld this information from the public and knowingly lied each time they described the products as ‘safe and effective…’ ”
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.
May 25, 2024 - Part 9: On FDA buildings as virtual mailboxes to project the public illusion of biological product manufacturing regulation.
Some Bailiwick reporting and analysis of federal (HHS-CDC) and state health dept. quarantine/detention authority:
Oct. 17, 2023 - Texas and Oklahoma v. US Department of Health and Human Services and Xavier Becerra: case documents
Oct. 18, 2023 - There is never going to be another "deadly global pandemic." There have not been any in the past. [More on Texas, Oklahoma v. US-HHS]
Jan. 20, 2024 - On the historical development and current list of 'quarantinable communicable diseases.'
March 28, 2024 - Repeal state public health emergency, emergency management, and communicable disease control laws. “…For example, some of the Texas state laws identified in the 2012 table include…T.C.A. § 81.085(i) - Authorizes commissioner to ‘impose an area quarantine coextensive with the area affected’ by a communicable disease outbreak; authorizes health department officers to demand individuals disclose ‘immunization status;’ and authorizes law enforcement officers to ‘use reasonable force to secure a quarantine area and...prevent an individual from entering or leaving the quarantine area.’ ”
