Posted on
Morgan Lindstead | October 17, 2022

The newly proposed FDA Modernization Act has passed in the Senate and has big prospects for modernizing the drug development process and removing animal toxicology testing. 

On September 29th, 2022, the FDA Modernization Act passed in the Senate and began making its way to the House of Representatives. This Act seeks to remove animal toxicology testing in the drug development process by ending an “outdated mandate that required experimental drugs to be tested on animals before they could be used on humans in clinical trials.”

While this bill does not eliminate animal testing entirely, as research on animals is still needed at this time for systems in which in vivo alternatives do not exist, it places a particular emphasis and validation on the in vivo methods that have already been created and authorize their use as an alternative to animal toxicology testing. 

Modern Advancements and in vitro Alternatives to in vivo Toxicology Testing:

In recent years, advancements have been made toward the replacement, reduction, and refining of animal research, also known as the 3Rs. This includes replacing the emphasized need for animals in research by using other in vitro methods, such as cellular models and biochemical or cell-based systems. Examples of these systems include “organs-on-chips,” a variety of cell-based tests and tissue models including MatTek Life Sciences’ EpiDermTM Tissue Model, and MatTek Life Sciences’ EpiAlveolar for studying the lung and the effect of inhaled chemicals, pathogens, and more. These new developments cost a fraction of what animal studies cost, which would save research institutes thousands of dollars and countless time. 

Animal Toxicology Studies in Drug Development:

The drug development process, mediated by the FDA, is made up of a variety of phases. The first phase in this process is the drug discovery phase, in which a new compound is synthesized with the expectation that it causes a desired effect on a patient population. However, before this compound can make its way onto convenience store shelves and pharmacy counters, it must first undergo the later phases of the FDA’s mandated drug development process. The next step in this process, Phase 2, is when “Drugs undergo laboratory and animal testing to answer basic questions about safety.” These first two Phases collectively take between three and six years. Phase 3, the clinical trial phase, is when this drug is finally tested on human volunteers, then takes another estimated six to seven years. Assuming everything goes smoothly in the clinical trials phase, the drug then moves on to be reviewed by the Food and Drug Administration (FDA) to decide if it will be accepted or rejected as a marketed drug. This process is long and costly, especially in relation to costs associated with animal toxicology testing alone. However, the new FDA Modernization Act will help to eliminate some of these costs as alternatively engineered in vitro methods cost much less than in vivo animal studies.

Why Animal Testing is Outdated – the Need to Switch to Modern Methods

While it is true that in vitro systems are not yet capable of mimicking complex diseases such as Alzheimer’s or cancer, efforts taken to understand these diseases using animals have been, in large part, uneventful, costly, and redundant, only serving to further our understanding in how this disease works in other animals rather than how it works in humans and improving human quality of life. To further support this claim, according to the former National Cancer Institute Director Dr. Richard Klausner, “The history of cancer research has been a history of curing cancer in the mouse…We have cured mice of cancer for decades, and it simply didn’t work in humans.” Clinical trials, which come after the animal testing phase of drug development, continue to contradict results found in the animal testing phase. 

While the importance of animal testing is often highlighted by textbooks and research organizations that utilize these methods, what these sources often fail to mention is how costly animal testing is and how these emphasized “breakthroughs” in research are discovered in relation to the animal being tested on. In other words, further research on humans is still required to see if the discovered system, drug, or protein exists the same way in humans, which often does not occur as model organisms consist of a wildly different genome than that of humans. 

What the Passing of the FDA Modernization Act Would Mean for Vanderbilt and Institutions Like it

As a prominent research institution, eyes are on Vanderbilt not just in the scientific community, but in the global community as well. Thus, when in vitro methods like organs-on-a-chip are used in research, it plays a monumental role in the validation of this technology and sets a standard to be followed by other research institutions around the world. Vanderbilt and similar research institutions have a need to stay relevant, which requires that they stay in good standing with public opinion; in order to do so, they must be willing to abide by a society subject to change. As evidenced by the Protection of Dogs and Cats from Unnecessary Testing Act recently passed in the State of California, the emphasis on removing animals from toxicology testing is in alignment with public values. This bill, which will take effect in January 2023, will prohibit the use of traditional animal testing with dogs and cats when an alternative method has been approved and recommended by the state. 

The FDA Modernization Act is a call to action for research institutions across the country, declaring that the time has come to dispose of the practice of animal toxicology studies. By continuing to use these methods, money is being wasted, time is being lost, and the lives of animals are needlessly being sacrificed. The use and adoption of cruelty-free in vitro toxicology methods would not only be beneficial monetarily for Vanderbilt and similar institutions but would also be in alignment with public values and assert a new standard for global research. 

Bibliography

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By Morgan Lindstead