 After Morton Mintz broke the story in July 1962 , there was a substantial public outcry . The Kefauver Harris Amendment was passed unanimously by Congress in October 1962 to strengthen drug regulation . Companies were required to demonstrate the efficacy of new drugs , report adverse reactions to the FDA , and request consent from patients participating in clinical studies . The drug testing reforms required " stricter limits on the testing and distribution of new drugs " to avoid similar problems . The amendments , for the first time , also recognized that " effectiveness [ should be ] required to be established prior to marketing . " The new laws were not without controversy . 
