On Oct. 7, 2021, U.S. Senators Cory Booker, D-N.J., Rand Paul, R-Ky., Ben Ray Lujan, D-N.M., Mike Braun, R-Ind., and John Kennedy, R-La., introduced the FDA Modernization Act of 2021 to modernize drug development and to authorize the FDA to accept human-relevant testing methods for safety and efficacy testing. Collaborating with other groups, CCS is leading the scientific support for this bill.
The existing drug development paradigm, established by statute in 1938 under the Federal Food, Drug, and Cosmetics Act (FFDCA), requires animal tests to be conducted in all new drug applications. But this 80-year-old requirement has not caught up with the science. Major developments have been made in creating effective test methods that are based on human biology.
The FDA Modernization Act of 2021 amends the FFDCA by broadening options for drug development to include modern, innovative, human-relevant test methods. By doing so, this bill will speed up the discovery and lower the costs of new life-saving treatments. You can read more about the major developments surrounding the FDA Modernization Act of 2021 here.
CCS is saving and improving lives by catalyzing the world’s transition to human-specific medical research.