Victory! FDA Modernization Act 2.0 Signed into Law

• More than 90 percent of drugs that pass animal tests fail during human clinical trials because of safety problems or for lack of efficacy.
• The science of biomedical research has been substantially transformed since the FFDCA was enacted in 1938 and now includes a variety of advanced testing methods that are based on human biology and that can better predict how humans will respond to drugs than animal tests.
• On average it takes 10-15 years and $1-$6 billion to develop a single new drug. These drug development costs are then passed on to consumers in the form of high drug prices.
• There is no approved treatment for most human diseases, in large part because of the unreliability of animal testing.
  Many effective medications and perhaps cures were likely prematurely abandoned due to misleading results in animal tests.

What the FDA Modernization Act 2.0 does:

• Updates the 1938 Federal Food, Drug, and Cosmetics Act (FFDCA).
• Lifts the requirement for animal testing,
• Allows the use of human-relevant tests including organ chips, 3-D human organoids, and sophisticated computer modeling in place of unreliable animal tests.