Washington D.C., March 24, 2022
In a positive development, last week the House Energy and Commerce Health Subcommittee held a hearing on the FDA Modernization Act of 2021 as part of a larger legislative effort to promote innovation and the future of medicine. The FDA Modernization Act of 2021 is a key legislation designed to modernize drug development.
With bipartisan support, the legislation H.R 2565 was introduced in the House in April 2021 by Reps. Elaine Luria, D-Va., Brendan Boyle, D-Pa., Nancy Mace, R-S.C., Vern Buchanan, R-Fla., and Mikie Sherrill, D-N.J. A companion bill S.2952 was introduced in the Senate in October by Senators Corey Booker, D-N.J., Ben Ray Lujan, D-N.M, Rand Paul, R-Ky., and John Kennedy, R-La.
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, even though 90—95% of drugs that pass animal testing fail when tried in humans. But major developments have been made since 1938 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.
“This hearing is a key step in the right direction,” said Dr. Zaher Nahle, Chief Science Officer at CCS. “It is vital that our elected leaders have all the facts as they advance legislations to spark innovation and benefit patients. As evident by our 2022 Investor Summit, there is a need to support innovative testing methods.”
The bill is endorsed by major scientific entities and CCS partners, including the BICO group and its companies, MatTek and CELLINK; Emulate; Humabiologics; Regenerative Medicine Development Organization (ReMDO); Obalata Sciences, AxioSim; Paul Watkins, MD, Director of the Institute for Drug Safety Sciences at the University of North Carolina, Chapel Hill; Donald Ingber, MD, PhD, Founding Director of the Wyss Institute at Harvard University; and others.