The change is courtesy of the FDA Modernization Act 2.0, a bill Senator Rand Paul’s (R-KY) and Senator Cory Booker’s (D-NJ) first introduced back in October 2021. Nearly a year later, the bill unanimously passed through the Senate and then the House of Representatives. The FDA Modernization Act 2.0 made its way to President Biden’s desk last month and cleared its final hurdle just days before 2022 came to a close.
The law eliminates an animal toxicity testing mandate implemented in 1938. Rather than having to test medical treatments on rodents and other non-human animals, companies can now skip directly to the human trial step toward commercialization. Companies will still have the option to test their products on animals if they so choose.
The shift follows a long streak of impassioned investigation into animal testing’s validity and real-life practicality. Researchers have warned for years that animal drug tests aren’t as reliable as they’re made out to be. Aysha Akhtar, a neurologist and animal ethicist, published a paper in 2015 discussing the dangers associated with assuming a product is safe or effective on humans just because it was on mice, rats, dogs, or monkeys. This discrepancy can largely be blamed on physiological and genetic differences between species. Anthropologists like Emory University’s Todd Preuss have echoed this sentiment, saying that mice and other common test subjects aren’t the “generic mammals” laboratories make them out to be.
(Image: Janet Stephens/Wikimedia Commons)
But if companies don’t test their products somehow before moving to human trials, how can they—or more importantly, the public—know those products are safe? Akhtar has historically advocated for predictive human models: In her paper, she mentions “human organs grown in the lab, human organs on a chip, cognitive computing technologies, 3D printing of human living tissues, and the Human Toxome Project.” Some scientists have even proposed using computer simulations, like models representing human heart cells, to predict the likelihood of adverse drug effects in humans. This process, known as in silico, is already finding success with several pharmaceutical companies through a program called Virtual Assay.
“The FDA Modernization Act 2.0 will accelerate innovation and get safer, more effective drugs to market more quickly by cutting red tape that is not supported by current science, and I’m proud to have led the charge,” said Paul in a statement. “The passage of this bipartisan bill is a step toward ending the needless suffering and death of animal test subjects.”
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