FDA 2.0 Modernization Act
This new law will eliminate the mandate of animal testing for new drugs coming to market to treat humans.
The bipartisan Bill 5002 - FDA Modernization Act 2.0 was signed into law by Joe Biden on December 29, 2021 as part of the 1.2 trillion Omnibus Bill. Its two main sponsors were Senators Rand Paul (R) Kentucky and Cory Booker (D) New Jersey. The bill amends the original 1938 Food Drug and Cosmetics Act that mandated animal testing to investigate the effectiveness and safety of drugs and vaccines.
Supplanting animal tests are human trials and three more recent testing protocols: cell-based assays, organ chips & microphysiological systems, and sophisticated computer modeling while animal testing will become optional. Because these methods are newer, they are being described by the bill's sponsors and animal rights groups as “superior.”
Cell-based assays measure and detect cell viability and proliferation, cytotoxicity, apoptosis, necrosis etc. Organ chips mimic the human body or organ's biological environment but cannot measure the interactions of the drug on other cell types and tissues. Computer modeling works similarly to weather or flight simulation computer programs and are meant to predict potential adverse side effects.
Scholarly and scientific articles make the case that animal testing is superior to computer and cell-based tests because of the complexity of biochemical processes and interrelated pathways in humans. Humans are 98% genetically similar to mice and both species suffer from many of the same diseases such as cancer, diabetes and heart disease. And because mice have much shorter life spans, long-term side effects can be measured in a much shorter period of time. Additionally, testing for teratogenicity (ability to cause birth defects in a fetus) and endocrine disrupting side effects takes several generations using transgenic mice and cannot be duplicated with cell-based tests.
Approximately 95% of warm-blooded animal used in laboratory tests are rodents. In addition to their role in the discovery of new ways to treat, prevent and cure diseases, organ transplant advances and the use of immunosuppressant drugs were accomplished through animal testing.
Animal rights groups see no benefits in animal testing and claim humans have no right whatsoever to make decisions for sentient animals especially if those decisions cause pain. In light of those concerns, in the past 50 years researchers have adopted ethical testing practicing the 3Rs principle: replacement, reduction and refinement. Reduce the number of animals by sharing research so that others don't duplicate the experiments killing animals unnecessarily. Replace or supplement the use of animals with acceptable alternative techniques whenever possible. And finally refine testing methods to reduce as much as possible the pain, suffering and distress the animals experience with the use of anesthesia and analgesia, along with training the animals what to expect in the lab. Public opinion polls demonstrate stronger support for animal research when these principles are put into use. Each side has ceded ground in the debate, neither being completely satisfied but coming to an acceptable consensus in which the public at large accepts the necessity and practice of humane animal testing.
Formerly, regulatory agencies have been unwilling to side with militant animal rights activists and groups who demanded the total elimination of animal testing mandates due to their official rol.e in protecting the public from harm caused by unsafe or untested drugs or procedures. As much as 83% of all Nobel Prizes awarded in medicine have involved animal research and without it, the patient is denied their ability and right to make an informed decision based on an accurate risk/benefit analysis. A 2016 Johns Hopkins study determined that medical error -or iatrogenic harm - was the third leading cause of death in the United States. Our government accused it's citizens of spreading “disinformation” or worse, causing unnecessary death by questioning their version covid-19 narrative, which has never once mentioned VAERS or the unimaginable and previously unheard of vaccine injury and death.
In light of the sheer volume of serious, life-threatening and fatal adverse events reported in VAERS, it would be incumbent on government and regulatory agencies to proceed with extreme caution in loosening the regulation of this important phase of research protocols. Yet they are eliminating the most important mandate of all when the pharmaceutical companies won't stand by their products, profit scandalously, enjoy immunity from civil suits and send deliberately blank package inserts inside the boxes of covid-19 injectables which nullifies the process of informed consent. It is not only an ethical but also a legal obligation of healthcare providers to fully inform those undergoing any medical treatment or intervention and yet doctors will deny needed care to those who refuse to take such a daunting risk.
The Biden administration decries the lack of trust the populace has for the current vaccines but continues to do the very things that caused the erosion of trust in the first place - protecting a big pharma industry that financially contributes to both political parties and in turn suffers no consequences for their negligence or fraud. Yet they continue their coercion that everyone submit to a novel and dangerous gene therapy that its makers admitted was never properly tested. In light of current circumstances, eliminating this mandate can only be seen as a dereliction of duty and breach of trust to we the people.
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