FDA Commissioner Margaret Hamburg views the agency’s mission as one of fostering public health, she said earlier this month in a piece published in the New England Journal of Medicine on her first day on the job. In an interview in this morning’s WSJ , she describes some of priorities she has for the agency. Among them: taking a “hard look” at the FDA’s medical-device division. The video with WSJ’s Alicia Mundy has more. The device division has been a hot-button area amid concerns about how much influence the industry has on regulators and if they have been too easy on device makers in approving products. The medical-device industry is worried that different standards could hurt patients and companies alike. “The current system for medical device regulation is fundamentally sound and gives FDA the flexibility it needs,” Janet Trunzo, an executive vice president at

Advanced Medical Technology Association , told the WSJ. Transparency is another item high on Hamburg’s to-do list and she already has named a task force to look into what more information the acency can make public without giving away company secrets. Hamburg also wants to move quickly when action is warranted — such as with safety warnings and enforcement action — while taking the time when risk vs. benefit decisions need to be made. “We don’t feel we can take weeks or months to negotiate a plan for a recall” or relabeling, Hamburg told the WSJ. “Industry ultimately understands it’s in their best interest, too.” In a separate interview in the Washington Post , Hamburg said, “We’ve changed our posture to one that is more aggressive and forward leaning.”

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Hamburg Puts Faster Action, Medical Devices on FDA’s List