Industry user fees would fund 98% of the proposed budget increase. The FY 2013 request covers the period from October 1, 2012 through Sept 30, 2013.
In addition to recommending new user fees to support the review of generic drugs and biosimilars, the FDA budget also contains increased funding for priorities such as import safety, medical countermeasures and research facilities to protect patients and consumers.
Margaret Hamburg, MD, commissioner of Food and Drugs, said: “These are austere budget times, and the FDA budget request reflects this reality. Our budget increases are targeted to strategic areas that will help speed the availability of new medical products, address the challenges of increased globalisation and allow FDA to fulfil its public health duties more efficiently.
“With FDA-regulated products accounting for about a quarter of each dollar that Americans spend, these budget priorities will benefit patients and consumers and strengthen our economy.”
Source: FDA
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