As part of the fiscal year 2023 appropriations bill, legislation was passed that allows new medicines not to be tested in animals to receive U.S. Food and Drug Administration approval, according to Science.org.
This legislation was signed into law by President Joe Biden late last month and it replaces a stipulation from 1938 that called for potential drugs be tested for safety and efficacy in animals.
Usually, the FDA “requires toxicity tests on one rodent species such as a mouse or rat and one nonrodent species such as a monkey or dog,” in order for drugs to be approved in the U.S., Science said.
According to the publication, companies use tens of thousands of animals for these tests annually. Even so, it said more than 90% of drugs that enter the human clinical trial stage fail because they are unsafe or not effective, a figure backed up by the Center for Contemporary Sciences.
“Animal models are wrong more often than they are right,” said Don Ingber, a Harvard University bioengineer, according to Science. His lab developed organ chip technology now being commercialized by the company Emulate, where he sits on the board and owns stock.
In the new legislation signed by Biden, organ chips are mentioned. Science explained that these “consist of hollow channels embedded in silicone-based polymers about the size of a computer thumb drive,” lined with living cells and tissues from organs such as the brain, liver, lung, and kidney. When fluid flows through the channels, it mimics blood flow through tiny vessels and other functions of living organs.
For example, a human liver chip could warn of toxicity related to experimental drugs. A study published last month in the Nature journal found that “incorporating predictive Organ-Chips into drug development workflows could substantially improve drug discovery and development, allowing manufacturers to bring safer, more effective medicines to market in less time and at lower costs.”
“This is huge,” says Tamara Drake, director of research and regulatory policy at the Center for a Humane Economy, of the new legislation, according to Science. “It’s a win for industry. It’s a win for patients in need of cures.”
On the other hand, Jim Newman, communications director at the Americans for Medical Progress group that advocates for animal research argues non-animal technologies are still “in their infancy” and won’t be able to replace animal models for “many, many years,” per Science.
Some drug companies have also been critical of animal testing in the past due to costs associated with it.
“FDA still retains tremendous discretion to require animal tests, he notes, and he doesn’t expect the agency to change tack anytime soon,” said the outlet.
Indeed, it said that it is unclear whether the new law will change FDA requirements in practice.
“Although the legislation allows the agency to clear a drug for human trials without animal testing, it doesn’t require that it do so,” Science explained. “What’s more, FDA’s toxicologists are famously conservative, preferring animal tests in part because they allow examination of a potential drug’s toxic effects in every organ after the animal is euthanized.”
Steven Grossman, a former deputy assistant secretary of health who advises companies on their FDA applications, said that the real import of the change is that it opens a door for the FDA and companies to discuss alternatives such as organ chips.
“Animal studies are frequently used to assess certain aspects of risk, toxicity, activity, or public health impact of FDA-regulated products that focus on a product’s nature, chemistry, effects (pharmacology), and its potential damage to the body (toxicology),” said the administration in material updated in September. “FDA is working to replace, reduce, and refine (the 3 Rs) dependence on animal studies by advancing development of, and evaluating new, fit-for-purpose non-clinical tools, standards, and approaches that may someday improve predictability.”
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