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On May 18th, the Energy & Commerce Committee passed H.R. 7667, the Food and Drug Amendments of 2022, without any dissent (55 -0, following a unanimous vote of 30 – 0 a week earlier in the Health Subcommittee). We are pleased to report that E&C Committee leaders included the FDA Modernization Act, H.R. 2565, as a rider. That measure was introduced last April by Reps. Buchanan, Luria, Mace, Sherrill, and Boyle. A companion to H.R. 2565, was introduced two months later by Senators Rand Paul, Cory Booker, Mike Braun, Ben Rey Lujan, and John Kennedy as S. 2952.
The full legislative package is set for final action for a full vote in the House in June and may pave the way for the phase-in of non-animal test methods in new drug development and a reduction in the use of animals. The Senate has issued a draft of a parallel legislative package which also includes the FDA Modernization Act language, with the two chambers hoping to complete all work on the new policies by summer’s end.
The current drug development model is broken. It relies solely on animal tests to determine the safety and efficacy of new drugs, but the reality is that 90 to 95 percent of drugs fail in human clinical trials after animal tests show safety and effectiveness.
The Food and Drug Administration’s (FDA) requirement that all drug candidates be tested on animals was implemented over three-quarters of a century ago, under the 1938 Federal Food, Drug and Cosmetics ACT (FFDCA). But the science of pharmacology has been radically transformed over the past several decades, and the FFDCA, enacted in a different era, urgently needs to be updated.
Many of the FDA’s scientists and pharmaceutical industry experts, not to mention scientists and drug manufacturers around the world, believe that non-animal testing methods are superior for measuring the safety and effectiveness of new drugs.
Source: PETA (People for the Ethical Treatment of Animals)/Youtube
The FDA Modernization Act of 2021 (H.R. 2565 and S. 2952), currently pending in Congress with robust bipartisan support, would modernize the FFDCA by allowing for the use of scientifically supported test methods in drug development. While it doesn’t eliminate animal testing, it allows drug developers to opt to utilize superior, human-relevant methods, which will spare untold millions of animals immense suffering each year.
The reliance on animal testing has resulted in an exorbitantly slow, expensive, and ineffective drug development process that has impeded medical research and hindered the discovery of urgently needed treatments. Despite billions in funding for animal research into cancer and Alzheimer’s disease over several decades, the failure rate in drug development remains 97 percent for cancer and 99 percent for Alzheimer’s disease. Many of the drugs that appear successful in animal trials are not only ineffective when given to humans but also unsafe.
In addition to extremely high failure rates, the average drug costs anywhere from $1 to $6 billion and takes an average of 10 to 15 years to bring to market.
COVID-19 has shined a spotlight on our inefficient and outdated drug approval process. The rapid development of vaccines in one year that allowed for human clinical trials to proceed before animal testing was complete, with some relying on modern, human-based technologies, has shown that we can overhaul the current drug development system.
“The ongoing COVID-19 pandemic has made clear the need for rapid vaccine development, and this can be hampered by the lack of animal models that faithfully replicate human vaccination responses,” said Donald E. Ingber, M.D., Ph.D., Founding Director of the Wyss Institute for Biologically Inspired Engineering at Harvard University.
The requirement that drug candidates be tested on animals has resulted in the continued use of outdated and ineffective tests. The Draize test, devised in 1944 to measure irritancy caused by cosmetics by exposing rabbits’ sensitive eyes and skin to chemicals, is the most common method for assessing skin and eye irritancy in pharmaceuticals. A 2015 study revealed that it was used in 94 percent of all skin irritation tests and 60 percent of eye irritation tests for all drugs approved by the FDA between 2011-2014.
The Draize test has remained the traditional test for nearly eight decades, despite scientific studies for the last 40 years showing the Draize test is deficient at predicting human response and that other technologies, such as the Reconstructed Human Epidermis (RhE), are more accurate at predicting human response to drugs than the Draize test.
The FDA Modernization Act would eliminate the requirement that pharmaceuticals be tested on rabbits and other animals and allow for the use of modern, humane, and human-relevant tests.
One example of such a technology are organ-chips, small lab-grown tissues that are highly accurate at mimicking human organs. In a recent study, researchers assessed the performance of 780 human Liver-Chips to evaluate the toxicity of 27 known drugs. The study demonstrated that the Liver-Chip developed by biotech company Emulate, Inc. was able to correctly identify 87 percent of the tested drugs that caused drug-induced liver injury in patients despite passing through animal testing. At the same time, the Liver-Chip did not falsely flag any drugs as toxic.
In another example, a scientific team supported by the National Institutes of Health has created a tiny, bioengineered 3-D model that mimics the biology of chronic inflammatory demyelinating polyneuropathy and multifocal motor neuropathy, a pair of rare, devastating neuromuscular diseases. The researchers used the organ-on-a-chip, or “tissue chip,” model to show how a drug could potentially treat the diseases. They provided key preclinical data for a drug company to submit to the U.S. Food and Drug Administration to get authorization for testing in a clinical trial without any animal testing.
Animal tests are simply not predictive of the human drug response. In 19 out of 20 cases, a drug candidate that seems promising when given to animals – whether it’s rabbits, mice, dogs, or primates – fails in human clinical trials.
On September 2, 2021, FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee said animal models are “problematic” in assessing the safety risks of gene therapies derived from adeno-associated virus (AAV) vectors. There have been “severe” adverse events in AAV vector clinical trials, including instances of acute liver and kidney failure in children. One-third of the 500 children under the age of 2 treated with Zolgensma, a gene therapy medication, had at least one adverse event of liver toxicity.
Imagine those statistics applied to air travel. If you boarded a plane and the pilot announced you have a 5 percent chance of reaching your destination, would you question the FAA safety regulations overseeing the safety of air travel?
Such abysmal odds would signal that something needs to change. That is exactly what the FDA Modernization Act is intended to do with disease and drug research. It will provide scientists with the option to use sophisticated and modern technologies rather than being held to standards that were passed nearly a century ago and have long since been surpassed.
Contact your federal representatives in Congress today to support the FDA Modernization Act so that we can end this archaic requirement that impedes science and causes animals to suffer in cruel drug testing.
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