Dear Commissioner Gottlieb:
I commend your plans to streamline the drug approval process. As you know, the current failure rate for new drugs is staggeringly high and extremely expensive.
Current scientific opinion, including that of FDA, attributes the high failure rate to preclinical models, in particular, animal tests. And yet, FDA perpetuates dependence on animal tests by requiring animal data for investigational new drugs.
As you work to modernize the drug approval process by incorporating computer simulations and in silico models for clinical trials, it’s imperative that you also allow innovative scientists to gain approval from the FDA without requiring animal tests.
As long as FDA continues to require these tests, future work in drug development and safety testing will remain permanently hindered by weak translation from animal data.
