As your constituent, I am writing to urge you to support the FDA Modernization Act (H.R. 2565 and S. 2952), led by Reps. Vern Buchanan and Elaine Luria and Senators Rand Paul, Cory Booker, Mike Braun, and Ben Ray Lujan.
In March, the House Energy and Commerce Health Subcommittee conducted a hearing on the FDA Modernization Act and the bill currently has robust bipartisan support in the House and Senate.
The important bill will eliminate an outdated FDA directive, passed in 1938 under the Federal Food, Drug, and Cosmetics Act (FFDCA), that requires animal testing before a drug can be tested in human clinical trials. This archaic requirement is not supported by current science and impedes development of urgently needed drugs and treatments.
Science has advanced immensely since this law was passed and there are now countless innovative human-relevant technologies that can be used to test the safety and efficacy of drugs more accurately. Drugs deemed safe and effective in animals have a failure rate of 95% in human clinical trials, and it is nonsensical for the FDA to continue to require them.
In addition to being inaccurate and inhumane, animal testing causes unnecessary delays and exorbitant costs. The average drug costs upwards of $1 billion and takes approximately 10 years to make it to market. Allowing scientists to use more accurate human-based methods will speed up and lower the costs of drug development, while advancing treatments that are urgently needed.
It is imperative that regulatory requirements are aligned with scientific progress. Please support the FDA Modernization Act.