FDA’s Hamburg: ‘We Can Do Better Assessing Safety’

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For nearly two years, FDA commish Margaret Hamburg has been in the proverbial hot seat as the agency struggles to remake itself and, specifically, respond to widespread concerns about food and drug safety. In this brief chat as part of a series of interviews The New Yorker conducts with high-profile interviews, she discusses the risk-versus-benefit problem and the challenges of communicating necessary and complex information.

For students of the FDA, this is an opportunity to watch Hamburg address broader, philosophical matters, as opposed to a granular discussion of the nitty gritty of guidances, for instance. In any event, she does acknowledge that “we can do a better job of assessing safety and, partly we need to do a better job because science is evolving.”

The agency, she adds, does not want to stand in the way of the practice of medicine or improving health. Hamburg is amused by a scenario in which consumers are able to walk into a store, point a personalized device at a product and receive a warning about what is, and isn’t, appropriate use depending upon the individual’s genetic make-up. “I hope I’m not FDA commissioner then,” she laughs.

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