Washington Insider: John Kamp

The FDA must address its policies to accommodate the new medical and media environment

After six years as Commissioner of Food and Drugs, Dr. Margaret Hamburg announced last month that she is leaving the agency at the end of March. Although much was accomplished during her term, the agency still needs additional resources and more modern approaches to move it forward in 2015 and the years to come. 

“While there is still work ahead … I know that I am leaving the agency well-positioned to fulfill its responsibilities to the American public with great success,” Hamburg wrote in a February 5 e-mail to FDA colleagues. She ­highlighted some of the strides made while she was at the FDA's helm, including increasing the speed and efficiency of medical product reviews, especially for novel drugs and breakthrough therapies. 

Even though Hamburg ushered in these successful programs, there is room for improvement for the next Commissioner of Food and Drugs, particularly in regulating the marketing of biopharmaceuticals and devices. The FDA must address its policies to accommodate new medical and media environments while heeding the First Amendment. 

Much of that improvement could result from additional funding to handle both the complicated realities of
today's medical environment and the increased workload suggested in the excellent 21st Century Cures initiatives now being contemplated in Congress. In short, if the FDA is to continue its leadership rank as the best drug agency in the world, it needs the money and tools to do so. It's time for the White House and Congress to step up and increase the FDA's budget outside of the funding provided by industry user fees. 

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