FDA seeks $4.9 billion for FY 2016; Commissioner Hamburg Reflects on FDA's Accomplishments Over the Past Year

Dr. Margaret Hamburg will step down from her post as Commissioner of the FDA next month. Hamburg and the FDA were busy in the few days before the announcement of her resignation, however. The Agency released a budget request for FY 2016, and Hamburg wrote a recap of the FDA's past year. Below is a summary of both.  FDA's Budget for FY 2016 In FDA's budget request, Hamburg stated that the agency is requesting a total of $4.9 billion, including a $148 million budget authority to: increase focus on improved oversight of imported foods, combat the growing threat of antibiotic resistance, promote the development and appropriate use of reliable molecular and genetic diagnostics to “personalize” the diagnosis, treatment, and prevention of disease (which raises potential concern over FDA's desire to regulate laboratory developed tests), implement key FDASIA requirements to improve medical product review and inspections, and address the safety of compounded drugs. While most of FDA's requested increase is for food safety oversight, on the medical product safety side, they include a $33.2 million increase in budget authority to support its key safety priorities.  In its press release regarding the budget, FDA states that five major pieces of groundbreaking legislation passed since 2009 have greatly increased the FDA’s responsibilities. Hamburg writes: FDA’s responsibilities continue to expand as we work to fulfill the mandates of groundbreaki...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs