- The FDA is moving away from animal testing and considering a number of alternatives
- Alternatives include organ-on-a-chip technology, cell cultures, and mathematical modeling
- The FDA has sought 5 million dollars from the government to fund its non-animal methods initiative
When presented with medication, few of us consider the path those drugs have taken from the lab to our medicine cabinets. However, changes to the way drugs are developed are afoot, according to the American Chemical Society.
The Food and Drug Administration (FDA) is re-examining its decision to use animal-testing methods in drug development.
Under the FDA’s jurisdiction, animal testing is required for human drugs, vaccines, and other biological products. Most drugs will undergo preclinical animal testing. Then, the results of preclinical testing are presented along with proposals for how the drug may be tested in humans.
At this stage, the FDA will decide whether to move forward with testing the drug in humans.
However, the FDA is now considering technologies that do not involve the use of animals. So, why are they re-examining this requirement now and what could this mean for the way drugs are tested in the future?
The decision follows advancements in alternative testing methods and discussions surrounding ethical concerns.
“This decision may have been made due to increasing pressure from animal rights groups, scientists, and lawmakers,” says Abbas Kanani, superintendent pharmacist at online pharmacy Chemist Click.
“Some ethical concerns include the processes used in testing which can sometimes lead to a reduction in the number of animals, discrepancies with maintaining the balance between the suffering of animals and the overall benefit for humans, as well as the general respect for the animals’ dignity,” he explains.
Ethics aside, animal testing may not be the most effective way to test drugs meant for humans.
“Many drugs that work well in mice, are not necessarily effective in humans. Ultimately, this is down to the vastly different anatomy and physiology,” Kanani explains.
The rising cost of drug development is another problem. As well as raising ethical concerns and efficacy questions, Celean Camp, CEO of FRAME, a charity that researches scientific alternatives to animal testing, suggests that animal testing isn’t cost-effective.
“The inflation-adjusted cost of drug development
“There is an obvious need to streamline and increase the efficiency of the drug development pipeline. This would help increase the number of effective drugs reaching the market and reduce wastage of funds and animal lives.”
The decision to step away from animal testing begs an obvious question: what would replace it? There are a number of alternatives to animal testing.
“One of the most well-known alternatives is organ-on-a-chip technology that puts human cells in a small chip to mimic the responses of a human organ,” Camp explains.
“The fact that the FDA has given the Wyss Institute funding into organ-on-a-chip technology shows the potential this area could have for human health.”
Other testing methods include cell cultures, where human cells are grown in a laboratory. “This is an area the FRAME lab has a lot of experience with using tissue donated from local hospitals,” says Camp.
There are also mathematical modeling methods that, as technology develops, will see the use of patient data and human volunteers take a more prominent role.
“What’s very exciting about human-relevant, non-animal research is it opens up opportunities for patient-specific healthcare,” Camp enthuses.
With advancements in the field and increasing pressure to replace animal testing with more humane methods, how might the FDA’s drug testing model look in the future?
The FDA appears to be considering a number of non-animal research methods moving forward. In a meeting with its Science Board on June 14th, alternatives such as microphysiological systems in combination with cellular and computational methods were discussed.
Camp says the move away from animal testing isn’t just something we’re seeing Stateside but across the world too, with more governments exploring non-animal research and the EU strengthening its commitment to phasing out animal research.
However, change may be slow because, at the moment, non-animal methods receive very little funding, Camp points out.
“With increased confidence and funding, non-animal research methods have huge potential,” she says.
“What we would like to see is significant sums of money put into the development of animal-free testing methods to increase the human relevance of the outcomes of the preclinical testing phase.”
Camp says this would increase the number of potential drugs that make it to market and reduce the time the lab-to-market process takes.
To fund its Non-Animal Methods (NAMs) initiative, the FDA is asking congress for 5 million dollars in the 2023 fiscal year.
Though change may be slow, Camp believes the FDA’s decision can only be a good thing. She sees it as a win for animals and humans.
“Focusing on the development and uptake of non-animal methods allows us to focus on human-relevant models, and treatments, for the disease instead of using less relevant, more limited animal models with ethical concerns,” she says.
Additionally, Camp believes focusing on non-animal methods will open the door to huge advances in our understanding of human diseases and disorders. It could also speed up the development of new drugs whilst reducing the cost of research.
“By creating a range of methods closely based on our own human physiology we will be able to test more accurately, investigate diseases more clearly and create treatments that will hopefully give us answers where the current animal methods are not,” she says.