Animal funds

Why the FDA is exploring more alternatives

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The FDA is taking steps to move away from animal testing and experts say this could ultimately lead to the development of more effective drugs for humans. Getty Images
  • 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 asked the government for $5 million to fund its non-animal approach methods

When presented with drugs, few of us consider how far those drugs have traveled from the lab to our medicine cabinets. However, changes in the way drugs are developed are underway, according to the American chemical society.

The Food and Drug Administration (FDA) is reconsidering its decision to use animal testing methods in drug development.

Under the jurisdiction of the FDA, animal testing is mandatory for human drugs, vaccines, and other biological products. Most drugs will undergo preclinical testing on animals. Next, the results of the preclinical tests are presented along with proposals for how the drug can be tested in humans.

At this point, 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 reviewing this requirement now and what might it mean for how drugs are tested in the future?

The decision follows advances in alternative testing methods and discussions surrounding ethical concerns.

“This decision may have been made due to growing 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 animal numbers, deviations from maintaining the balance between animal suffering and overall human benefit, and the general respect for animals. dignity,” he explains.

Ethics aside, animal testing may not be the most effective way to test drugs for humans.

“Many drugs that work well in mice are not necessarily effective in humans. In the end, it depends on the very different anatomy and physiology,” says Kanani.

The rising cost of drug development is another issue. In addition to raising ethical concerns and questions of efficacy, Celean Camp, CEO of FRAMEa charity that researches scientific alternatives to animal testing, suggests that animal testing is unprofitable.

“The inflation-adjusted cost of drug development increased almost 80 times between 1950 and 2010,” she says.

“There is a clear 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 move away from animal testing raises an obvious question: what would replace it? There are a number of alternatives to animal testing.

“One of the best-known alternatives is organ-on-a-chip technology, which places human cells in a small chip to mimic the responses of a human organ,” Camp says.

“The fact that the FDA has provided funding to the Wyss Institute for organ-on-chip technology shows the potential this area could have for human health.”

Other testing methods include cell cultures, where human cells are grown in the laboratory. “This is an area where the FRAME lab has a lot of experience using tissue donated by local hospitals,” Camp says.

There are also mathematical modeling methods which, as technology develops, will see the use of patient data and human volunteers play a greater role.

“What’s really exciting about non-animal, human-relevant research is that it opens up opportunities for patient-specific healthcare,” enthuses Camp.

With advances in the field and growing pressure to replace animal testing with more humane methods, what might the FDA drug testing model look like in the future?

The FDA appears to be considering a number of non-animal research methods moving forward. During a meeting with its scientific council on June 14ealternatives such as microphysiological systems in combination with cellular and computational methods have been discussed.

Camp says the abandonment of animal testing is not just something we see in the United States, but around the world, with more governments exploring non-animal research and the EU stepping up its commitment to phase 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 enormous potential,” she says.

“What we would like to see is significant sums invested in the development of animal-free testing methods to increase the human relevance of results from the preclinical testing phase.”

Camp says this would increase the number of potential drugs coming to market and reduce the time it takes for the lab to market process.

To fund its Non-Animal Methods (NAM) initiative, the FDA is asking Congress for $5 million in fiscal year 2023.

Although change may be slow, Camp believes the FDA’s decision can only be a good thing. She sees it as a victory for animals and humans.

“Focusing on the development and adoption of non-animal methods allows us to focus on human-relevant models and treatments for disease instead of using less-relevant and more limited animal models with ethical concerns. “, she says.

Additionally, Camp believes that focusing on non-animal methods will open the door to huge advances in our understanding of human diseases and disorders. It could also accelerate the development of new drugs while 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 precisely, investigate diseases more clearly, and create treatments that will hopefully give us answers where the current animal methods are not,” she says.