In 1906, when President Theodore Roosevelt signed a bill to create what is now the FDA, one of his first actions was to delegate the oversight of food and drug safety to the agency’s scientists. In the 114 years since, FDA professionals have created a consumer safety net that has been a worldwide model for evidence-based public health policy. Indeed, for decades, when we and our predecessors spoke as FDA commissioners about issues of regulation and people’s health, the public knew we were speaking on behalf of experts whose judgments were grounded in science.
That is changing in deeply troubling ways. The White House has said it might try to influence the scientific standards for vaccine approval put forward by the FDA or block the agency from issuing further written guidance on its criteria for judging the safety and benefits of a potential Covid-19 vaccine. This pronouncement came just after key leaders at the FDA, the Centers for Disease Control and Prevention and the National Institutes of Health all publicly supported that guidance.