WASHINGTON, October 7, 2021 / PRNewswire / – Today, U.S. Senators Cory booker, D-New Jersey, Rand Paul, R-Ky., Ben ray lujan, D-NM, Mike Braun, R-Indiana, and John kennedy, R-The., introduced the FDA Modernization Act of 2021 to modernize drug development and authorize the FDA to accept test methods relevant to humans for safety and efficacy testing. Together with other groups, the CCS is leading the scientific support for this bill.
This bill is the companion of a bipartisan bill in the House.
“Having worked at the FDA for a decade, I have seen new drugs come in again and again, only for the majority to fail in clinical trials,” said CCS CEO Dr. Aysha Akhtar, MD, MPH. “Drug development in the United States is a broken system. Animal testing does not predict the safety and effectiveness of drugs in humans. About 95% of drugs that pass animal testing fail because “they are dangerous or ineffective in humans. Can you imagine jumping on an airplane and the pilot announcing that you have only about a five percent chance of landing safely at your destination? in desperate need of revamping the drug development process.
The existing drug development paradigm, established by law in 1938 under the Federal Food, Drug and Cosmetic Act (FFDCA), requires that animal testing be performed in all applications of new drugs. But this 80-year-old requirement hasn’t caught up with the science. Major developments have been made in the creation of efficient test methods based on human biology.
The FDA Modernization Act of 2021 amends the FFDCA by expanding drug development options to include modern, innovative, and relevant human-relevant test methods. In doing so, this bill will speed discovery and reduce the costs of new life-saving treatments.
“By changing just a few words in long-standing federal regulations, the FDA Modernization Act offers hope that we can move forward in the future using preclinical models relevant to humans for evaluations of the safety of drugs, such as human organ chips that mimic patient responses. with great fidelity, instead of animal models that we know most often fail to predict what is happening in humans, ”notes Donald E. Ingber, MD, PhD, Founding Director, Wyss Institute at Harvard University. “This seemingly minor change can have a transformative positive impact on human healthcare by shortening development time, lowering cost, and increasing the chances of success of future new drugs.”
“The European Parliament recently voted to phase out animal testing and replace it with methods suitable for humans. Now the United States must become a leader in this direction, ”said the Scientific Director of CCS, Zaher Nahle, PhD, MPA.
About the Contemporary Science Center
CCS is the pioneer of a paradigm shift towards innovative methods based on human biology. We champion technologies that are better for humans and that replace animal testing.
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SOURCE Contemporary Science Center