Victory! FDA Modernization Act 2.0 Signed into Law

What is the FDA Modernization Act 2.0 (S.5002)?

The FDA Modernization Act 2.0 is a bipartisan-supported Bill that updates the Federal Food, Drug, and Cosmetics Act (FFDCA) by lifting the requirement for animal testing to determine drug safety and effectiveness and allow for more human-relevant methods to be used.

Why we supported the FDA Modernization Act 2.0

Updating the FFDCA will help modernize drug development by broadening options for drug sponsors and encouraging innovation and use of 21st-century science to improve success in clinical trials, bring more treatments to patients sooner, and at a lower cost.

Using human-relevant testing methods instead of animal experiments can significantly benefit human health and drug development by:

  • Better predicting if drugs and vaccines will be safe and effective in humans than animal tests.
  • Better protecting people enrolled in clinical trials
  • Preventing the abandonment of useful medications.
  • Improving response to public health emergencies. In vitro and in silico models including human organ chips and cognitive computing technologies can be deployed rapidly to develop vaccines and drugs to address emerging health problems like pandemics.
  • 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.

Ewart, L., Apostolou, A., Briggs, S.A. et al. Performance assessment and economic analysis of a human Liver-Chip for predictive toxicology. Commun Med 2, 154 (2022). https://www.nature.com/articles/s43856-022-00209-1

Uwe Mark, et al., Biology-inspired microphysiological systems to advance patient benefit and animal welfare in drug development, 37 ALTEX 365-394 (2021), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7863570/

Jonathan Gardner, New estimate puts cost to develop a new drug at $1B, adding to long-running debate, BiopharamaDive (Mar. 3, 2020), https://www.biopharmadive.com/news/new-drug-cost-research-development-market-jama-study/573381/

Danilo Tagle, The NIH microphysiological systems program: developing invitro tools for safety and efficacy in drug development, 48 Curr. Opin. Pharmacology 146-154 (2019), https://pubmed.ncbi.nlm.nih.gov/31622895/

Aysha Akhtar, The flaws and human harms of animal experimentation, 24 Cambridge Q. healthcare Ethics 407-419 (2015), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4594046/

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