Phasing out of Animal Testing for Next Generation Drugs
New medicines need not be tested in animals to receive US Food and Drug Administration (FDA) approval. The Act 2.0 passed by Congress has created options for pharmaceutical companies to use novel technologies, and Artificial Intelligence as alternatives to animal testing.
By signing this into law in December 2022, President Biden responded to the emergence of nonanimal methods and growing public sentiment against animal research. The new approach is expected to accelerate innovation and get safer, more effective drugs to market more quickly by cutting red tape that is not supported by current science.
Current testing methods are often seen as unsafe or ineffective, adding further motivation to those who argue that animal experiments are wasteful and cruel. The FDA’s commitment to explore new approaches to animal testing also reflects the current thinking of the global biomedical community.
In 2014 the United Kingdom announced plans to replace the use of animal testing with “scientifically valid alternatives.” This was further supported in 2021 when the European Parliament voted in favour of phasing out animal testing in research.
Expectations are that new technologies, when validated, will lead to faster, cheaper, and more ethical products reaching the market.
The history of animal testing
The usage of animals to test the safety and efficacy of drugs has been practiced for centuries. In ancient Greece and Rome, animals were used to test poisons and medicines. In the 1800s, scientists started using animal testing in a more systematic way to study the effects of various chemicals on the body. In the early 1900s, animal testing became more widely accepted as a method of evaluating the safety of new drugs. With the passing of the Food, Drug and Cosmetic Act in in the 1930’s, the US required all drug manufacturers to prove the safety of their products before they could be marketed. In the 1950s and 1960s, due to the development of new drugs that required extensive testing, the use of animals in drug development increased dramatically.
Overall, animal drug testing has a long and complex history. While it has significantly contributed to the development of many life-saving medicines, it has also been the subject of controversy and ethical debate.
What are some of the solutions?
There are several emerging technologies that have the potential to replace the use of animals for drug testing. Some of these include:
- In vitro models. These are laboratory-based methods that use human cells, tissues, or organs to model human biological processes. In vitro models can be used to study the effects of drugs on human tissues, such as liver or kidney cells, and can provide a more accurate representation of human physiology than animal models
- Organ chips and microphysical systems. Human cells and engineered structures are used to create an environment that models the function of specific organs to test drug effects across diverse human populations. This is to help the development of drugs in a safe and efficient manner. An example of this approach is the use of a human liver chip to act as a warning signal of toxicity when an experimental drug causes cell damage.
- Computer models. Developments in artificial intelligence (AI) and machine learning allow scientists to utilize existing data to its fullest. Computer models are used to simulate the interactions between drugs and human tissues, providing insights into drug behavior and potential side effects. Computer simulations can also be used to screen large numbers of compounds for potential drug activity, reducing the need for animal testing.
Despite the promising alternatives to animal testing more research into the efficacy of the new methodologies is required. Pro animal research scientists are downplaying the new initiative, arguing that non-animal technologies won’t be able to replace animal models for many years. They believe animal testing to be a more precise way to determine the effectiveness of drugs. In the meantime, companies can still exercise the option of testing drugs on animals.
Although the legislation allows the FDA to clear a drug for human trials without animal testing, there are still diverse areas where the use of animals for testing is inevitable. Life-threatening diseases like cancer, require exceptional accuracy. Toxicologists prefer animal testing because they allow comprehensive examination of a potential drug’s toxic effects in every organ, rather than putting human trial participants at risk.
Funding for the development and validation of the new alternative methods remain an area of concern for the FDA and scientists who rely on federal funds. The US National Institutes of Health, known as the largest public funder of biomedical research in the world, currently has no program dedicated to developing alternatives to animal testing.
The FDA Modernization Act 2.0 neither changes the regulatory process for drugs, nor eliminates animal use in research work. Nonetheless, pharmaceutical companies will now have the option to use alternative methods of testing drugs before they enter human trials. The usage of animals should be curtailed to research where it is scientifically necessary and should require special assessment under strict ethical guidelines.