FDA Thumbing Its Nose at Congress On Implementing the FDA Modernization Act
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Expanding Use of Primates in Drug Testing Is a Threat to Public Health
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Expanding Use of Primates in Drug Testing Is a Threat to Public Health
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Congress Eliminates 1930’s Animal-Testing Requirement
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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

Outdated Regulations

FDA must initiate rulemaking so outdated regulations comport with the revised statute and Congressional intent.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

Regulatory Clarity

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.

Read our Fact Sheet

on the FDA Modernization Act 3.0

HERE