FDA Must Take Immediate Steps to Implement the
FDA Modernization Act 2.0
The Food Drug and Cosmetics Act was amended in 2022 to allow for human-relevant nonanimal test methods, lifting the mandate for animal testing.
The current state
FDA must initiate rulemaking so outdated regulations comport with the revised statute and Congressional intent.
Deliberate Ambiguity at FDA
Current FDA programs to evaluate and accept nonanimal test methods are vague, ineffective, top-heavy, and lack transparency, failing to set up the agency or drug developers for success. FDA must end its deliberate ambiguity practice regarding the use of animals in preclinical research.
the path forward
FDA must create a clear pathway for regulatory acceptance of nonanimal test methods.
Break the status quo
FDA must act expeditiously to change the drug development paradigm as Congress intended. Otherwise, the 90 to 95% failure rate in clinical trials of drugs that pass animal tests for safety and efficacy fail in human trials will continue.