Dr. Robert Califf, Commissioner

Food and Drug Administration

10903 New Hampshire Ave.

Silver Spring, MD 20993-0002

Dear Dr. Woodcock,

On behalf of the undersigned, we are writing to urge the FDA to update its regulations regarding new drugs, shed animal testing wherever possible, and substitute state-of-the-art, human-relevant nonclinical test methods.  It's past time to move drug development into the 21st Century.
 
Animal tests have shown to be unreliable  predictors of  human reaction to new drugs that enter clinical trials.   The fact is that drugs entering human trials have  a 90 to 95% failure rate.
 
Your predecessor announced plans to permanently adopt any COVID-19 strategies that speed up the drug development process and remove any unnecessary barriers to get drugs and vaccines approved quickly.  He vowed to remove any unnecessary barriers and to streamline FDA processes to enable quicker reviews and authorizations.  
 
But FDA has ignored one critical barrier to change that is long overdue. Unreliable animal tests slow down the process and send researchers in the wrong direction. The unacceptably high failure rate in clinical trials is due in part to drugs found safe in nonclinical animal tests later failing during human clinical trials.  Animal data are notoriously unreliable for predicting human safety and efficacy, but FDA still requires these tests for product submission, to the exclusion of more predictive, non-animal tests.
 
The Center for Responsible Science – an affiliate of the Center for a Humane Economy and Animal Wellness Action – petitioned the FDA in 2015 to broaden options for drug developers to use the nonclinical test method most likely to predict human response based on scientific evidence.  After six years, FDA has not acted on this request.
 
It's time for FDA to weigh in. 
 
Congress certainly is. In July, the U.S. House Appropriations Committee has included language in the Fiscal Year 2021 Agriculture-FDA spending bill urging FDA to update its regulations to allow for the use of human-relevant non-animal test methods.  A similar effort is underway in the U.K. to urge regulatory bodies to update regulations to accelerate the use of human-relevant test methods, without the use of animals for all diseases in the wake of the pandemic.
 
It's time for FDA to update its ossified decades-old regulations and requirements for animal tests and to allow for nonclinical test models that are predictive of what will happen in humans in clinical trials. It's just good science and common sense. It's time for FDA to trust the science.

Sincerely,

Tamara Drake

Director of Research and Regulatory Policy

Center for Responsible Science

Wayne Pacelle
President

Center for a Humane Economy