A step to banning animal testing of medicines?
"New medicines need not be tested in animals to receive U.S. Food and Drug Administration (FDA) approval, according to legislation signed in late December 2022. The change—long sought by animal welfare organizations—could signal a major shift away from animal use after more than 80 years of drug safety regulation. In place of the 1938 stipulation that potential drugs be tested for safety and efficacy in animals, the law allows FDA to promote a drug or biologic—a larger molecule such as an antibody—to human trials after either animal or nonanimal tests. The Center for a Humane Economy, a nonprofit animal welfare organization and key driver of the legislation, and the nonprofit Animal Wellness Action, among others that pushed for changes, argue that in clearing drugs for human trials the agency should rely more heavily on computer modeling, “organ chips,” and other nonanimal methods that have been developed over the past 10 to 15 years. “Animal models are wrong more often than they are right,” says Don Ingber, a Harvard University bioengineer whose lab developed organ chip technology now being commercialized by the company Emulate, where he sits on the board and owns stock. Last month, Lorna Ewart, chief scientific officer at Emulate, Ingber, and colleagues published a study highlighting the potential of this technology. The company’s liver chips correctly identified 87% of a variety of drugs that were moved into human studies after animal studies, but then either failed in clinical trials because they were toxic to the liver or were approved for market but then withdrawn or scaled back because of liver damage. The chips didn’t falsely flag any nontoxic drugs. Article goes on to discuss new testing alternatives and the opposing viewpoint that animal testing is still necessary. It remains unclear just how much the new law will change things at FDA. Although the legislation
allows the agency to clear a drug for human trials without animal testing, it doesn’t
require that it do so. 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..." -
https://www.science.org/content/art...ug-trials?mc_cid=e429d5fd1a&mc_eid=cb009e1e09