US FDA's Hahn Promotes Provider Role In Boosting Public Confidence In COVID-19 Products
Agency commissioner appeals to AMA audience to communicate message that FDA review decisions are based on good science.
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Beyond vaccine experts, specialists in medical areas where there might be safety concerns, as well as epidemiologists, could be helpful to aid the FDA in understanding the data in a coronavirus vaccine application.
In a JAMA article, senior FDA leaders state that the outside advisers will be needed to ensure transparency given the potentially widespread use of the vaccine.
Hahn’s communications, which go far beyond the claims a sponsor could make of an investigational product, are raising new concerns about the agency’s ability to serve as a science-based regulator during the coronavirus pandemic. HHS Secretary Alex Azar and NIAID Director Anthony Fauci have also touted the lifesaving nature of plasma donations for COVID-19, even though the treatment is still unproven.