LAUSR

Science-based decisions on drug safety are threatened by political interference For the better part of a century, the U.S. Food and Drug Administration (FDA) preserved public health by rigorously applying the scientific method. The central tenet of the Food, Drug, and Cosmetic Act of 1938 which created the FDA calls for “experts qualified by scientific training and experience to investigate the safety of drugs.” In recent times, however, partisan political interposition has grown increasingly worrisome. As the sole arbiter standing between a new drug application and a potential public health calamity, the FDA can hardly afford to be buffeted by undue political interference. In a recent salvo in this decades-long tug-of-war over politics and independence, seven former FDA commissioners, hailing from both sides of the political aisle and spanning many administrations, recently recommended that the “FDA should be an independent federal agency reporting to the President” (1, 2). It is against this backdrop that we explore the utility, desirability, and feasibility of restructuring the FDA charter with political insulation and administrative streamlining in mind. Amid uncertainty over leadership and direction at the FDA since the commissioner stepped down in April, it is a particularly critical time to reflect on how to enhance the independence of the FDA in keeping with its enabling statute.