FDA Modernization Act 3.0

It is time to pass the FDA Modernization Act 3.0 to help phase out the use of animals in research.

 

An estimated 4 animals die every second in experiments around the world.

 

The Food and Drug Administration (FDA) Modernization Act 3.0 recently passed the House of Representatives, and the Senate version was passed last year. Now, the Senate must pass the House version of the bill, so it may go to the president to be signed into law. 
 
Animals used for research are force-fed, burnt, and blinded by products and infected with disease to discern how much will kill them. - all this, when we already know that each species responds differently to substances.

 

The Food and Drug Administration (FDA) specified in its Roadmap to Reducing Animal Testing in Preclinical Safety Studies that "Over 90% of drugs that appear safe and effective in animals do not go on to receive FDA approval in humans predominantly due to safety and/or efficacy issues." This means that 9 out of 10 times animal tests incorrectly predict what will happen to a drug in humans.

 

Animal tests are also subject to significant variability. Factors such as the animal's age, sex, diet, housing conditions, bedding materials, and even the laboratory environment can influence experimental outcomes. As a result, findings may differ not only between laboratories, but also within the same laboratory when experiments are repeated. This means that animal tests are not reliable.

 

Furthermore, many animal models involve the artificial induction of disease states that are used to 'model' diseases like arthritis, Alzheimer's disease and cancer. However, these artificial conditions do not fully replicate the complexity and underlying biology of naturally occurring human diseases. Therefore, this approach can produce misleading results. 

 

The research is generally conducted in secret, so the pain and suffering of these animals  are not subjected to wider scientific and public scrutiny, nor are modern, advanced techniques promoted enough.
 
A wide range of species are used in regulatory (safety) testing and research including dogs, mice, rats, monkeys, fish and many more.

 
In US laboratories alone, an estimated 12+ million animals are experimented on each year. 

 

Although much of the data is underreported and distorted, it is estimated that hundreds of thousands of animals, including guinea pigs, dogs, cats, rabbits, hamsters, and monkeys, die each year in US experiments.

 

However, many are shocked to learn that this excludes the use of birds, mice, and rats, who are estimated to be used for 95% of experiments.

 

We need to keep pressing our legislators for two measures: 

 

 

In the time it has taken you to read to here, around 250 animals will have died in experiments, and we are unlikely to ever find out why. Let's end that secrecy.

 

The FDA and other agencies have been slow to act on their commitments to phase out animal research.

 

The FDA Modernization Act 3.0 would require the FDA to consider "nonclinical tests" as a sufficient research method for FDA approval of a drug or product. The bill requires the FDA to incorporate "nonclinical tests" into its regulations concerning experiments, which will allow "nonclinical tests" to satisfy the FDA's testing standards.

 

"Nonclinical tests" include New Approach Methodologies (NAMs) that do not rely on subjecting animals to cruel and unnecessary experiments. Such NAMs include "computer modeling, organ chips, and microphysiological systems." Although animal tests would still be permitted, this bill would require the FDA to consider alternatives to animal testing: NAMs.

 

Please support the FDA Modernization Act 3.0 (S. 355 and H.R. 2821) to advance science and technology for faster, more relevant results, replacing the use of animals, and benefiting research for human conditions.