FDA Reorganization Advocates Seek Senate Boost For Disease-Oriented Structure
This article was originally published in The Gray Sheet
Friends of Cancer Research proposes realignment of FDA to be organized more around disease areas and less around the distinctions between drugs, devices and biologics. The idea has generated some support from former commissioners and current officials, while others warn of unintended consequences.
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FDA's oncology drug guru Richard Pazdur will be heading a new cancer regulatory center aimed at bringing device, drug and biologics regulators together to support new innovations.
The White House held a summit on its Precision Medicine Initiative where President Obama emphasized the need to break down outmoded regulations, and suggested that the barriers between drug and device oversight need to be loosened. Also at the meeting: FDA and NIH announced new competitions and projects, including the launch of an effort to gather data from a million Americans over the next few years.
President Obama sent Congress a budget that would increase FDA's coffers by $360 million, but mostly from user fees. Advocacy groups say the proposal is insufficient considering the agency's growing responsibilities. Included in the request is money for a new Oncology Center of Excellence that would take a cross-agency effort to support development of combination therapies for cancer.