WASHINGTON, Dec. 23, 2022 /PRNewswire/ — In a significant step for the advancement of human health, Congress passed the FDA Modernization Act as part of the FY2023 Omnibus Appropriations Bill. It is now being forward to President Biden’s desk to be signed into law.
In Section 3209 titled “Animal Testing Alternatives,” the bill amends the regulatory guidance at the FDA that requires animal testing for drugs and biosimilars. The bill amends the Federal Food, Drug, and Cosmetics Act (FFDCA) to:
- Substitute the term “nonclinical tests” for the current “preclinical tests” (including tests on animals),
- Substitute the term “animal” for “nonclinical tests” and,
- Add a new section defining “nonclinical tests” to include human-relevant testing methods such as cell-based assays, microphysiological systems (such as Organ-Chips), or bioprinted or computer models.
This is a needed step to innovate therapeutic development and modernize medical testing. By broadening the options for drug developers to include modern and human-relevant testing methods, in place of less effective animal experimentation, the bill introduces a much-needed improvement to the drug development process. Such change is expected to speed up drug discovery and lower the cost of life-saving medicine.
The existing drug development paradigm, established by statute in 1938 under the FFDCA, requires animal tests to be conducted in all new drug applications submitted for regulatory approvals, even though 90—95% of drugs that pass animal testing fail when tried in humans.
But modern test methods have been shown to outperform animal tests by a wide margin. A recent, comprehensive study shows the superiority of Liver-Chips in predicting drug liver toxicity in humans, as compared to animal testing. The human Liver-Chips correctly identified 87% of drugs that caused serious liver toxicity and deaths in patients despite all of them passing through animal testing. Liver toxicity is one of the top safety problems that lead to drug failures and causes significant human harm.
In a recent opinion article published in Frontiers Medical Technology, CCS lists a dozen reasons why Organ-Chips are better than animal experimentation at modeling human diseases and for drug development.
CCS has been the scientific lead working with Congress members to forward the FDA Modernization Act and has built a coalition of scientific institutions in support of the bill, including the Wyss Institute at Harvard, MatTek, Emulate, BICO, and others.
“Testing methods that are based on human biology like Organ-Chips can better protect people from significant harm than animal testing,” says CCS CEO and Co-Founder Aysha Akhtar, MD, MPH. “It is also very likely that numerous effective treatments were abandoned early because of misleading results in animals. This is extremely concerning as millions of Americans are desperately waiting for better treatments, yet the outdated method of animal testing has likely caused drug developers to throw out useful medication and maybe even cures. It’s past due that the FDA’s regulatory process catches up with modern science.”
“We are extremely grateful,” Dr. Akhtar continues, “for the hard work by Congressmembers to pass this much needed bill that not only will further human health, but also reduce animal testing. It’s a win-win for humans and animals.”
Center for Contemporary Sciences (CCS) is pioneering a paradigm shift towards innovative, evidence-based research methods that are based on human biology. We champion technologies that are better for humans and that replace animal testing.
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SOURCE Center for Contemporary Sciences