Center For Responsible Science

TO PURSUE A SCIENTIFIC STRATEGY TO CLEAR THE WAY FOR DRUG SPONSORS TO EMPLOY HUMAN DERIVED TEST METHODS AND FOR THE FDA TO ACCEPT SUCH METHODS

THE CENTER FOR RESPONSIBLE SCIENCE (CRS) WAS FORMED TO PURSUE A SCIENTIFIC AND LEGAL STRATEGY TO CLEAR THE WAY FOR DRUG SPONSORS TO EMPLOY HUMAN-DERIVED TEST METHODS AND FOR THE US FOOD AND DRUG ADMINISTRATION (FDA) TO ACCEPT THOSE METHODS. ON JULY 31, 2015, CRS FILED A PETITION WITH FDA SEEKING AMENDMENT TO CERTAIN REGULATIONS THAT REQUIRE THE USE OF OUTDATED PRECLINICAL TEST METHODS IN DRUG AND DEVICE DEVELOPMENT (THE "REGULATION CITIZEN PETITION"). THE PETITION URGES FDA TO UPDATE DOZENS OF REGULATIONS TO ENSURE THE PRECLINICAL TEST METHOD MOST PREDICTIVE OF HUMAN RESPONSE IS USED DURING DRUG TESTING. CRS CONDUCTED RESEARCH REGARDING SERIOUS ADVERSE EVENTS IN HUMAN CLINICAL TRIALS THAT LEAD TO THE DEATHS OF TRIAL PARTICIPANTS. CRS DISCOVERED MORE THAN 165 TREATMENT RELATED DEATHS BETWEEN 2012 AND 2018. CRS HAD FILED SEVERAL AMENDMENTS TO THE REGULATION CITIZEN PETITION DISCLOSING THOSE DEATHS. CRS PRESENTED DOCUMENTED FAILURE OF ANIMAL-BASED PRECLINICAL TEST METHODS TO