Gottlieb’s job one

Four decades ago, in the aftermath of a narrowly avoided public health disaster, Bob Temple and a handful of his colleagues at FDA led a regulatory revolution. In the course of figuring out how to implement legislation Congress had passed in response to the thalidomide tragedy a decade before, Temple helped define how drug companies could comply with the law’s requirement to conduct pre-market “adequate and well-controlled trials.”

FDA’s regulations for demonstrating safety and efficacy transformed the way drugs were developed. The requirements the agency crafted, including for prespecified experimental and statistical protocols, propelled a scientific and medical revolution. The need to pass rigorous tests for scientific truth made it possible for the first time in history to confidently distinguish medicine from quackery...