FDA’s New Public Health Focus May Affect Vaccine, Antibiotic Reviews

FDA recently unveiled plans to factor the broader public health impacts of certain drugs and biologics, namely controlled substances and products treating communicable diseases, into its review and approval decisions -- a move two former FDA officials say could also significantly change how the agency weighs the benefits of vaccines and antibiotics. The policy shift will help align FDA’s regulatory decisions with its mission to protect public health, they add. But the Biotechnology Innovation Organization is pushing back against the...