FDA seeks $4.9B to implement FSMA

by Erica Shaffer
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WASHINGTON – The US Food and Drug Administration is asking Congress for $4.9 billion to implement the Food Safety and Modernization Act (FSMA). The request is part of President Obama's FY 2016 budget.

The overall budget request includes $147.7 million for initiatives tied to implement FSMA and management of medical product issues, the agency reported.

Specifically, more than $109.5 million will allow the FDA to implement fundamental requirements for domestic food and feed safety; acquire the technical staffing and training needed to support the law; provide the appropriate guidance to industry about the changes the law will bring; strengthen the role of the states in helping to ensure the safety of the country’s food supply; and build and implement a new import safety system.

Another $5 million would help fulfill the agency's staffing needs, which FDA said must increase by 70 percent by FY2016.

FSMA gives FDA increased regulatory responsibilities, the agency said. Additionally, FDA's scope has expanded to include regulation of "an ever-increasing number of food and medical products" from around the world.

“This budget accurately reflects the challenges FDA faces in a global regulatory environment, which is becoming increasingly complex and scientifically demanding,” said Commissioner Margaret A. Hamburg, M.D. “As FDA’s mission expands on several fronts — from the regulation of tobacco products to supporting the development of personalized medicine to ushering in a new era of food safety — we must possess the resources to run a modern agency that fosters innovation and ensures the safest possible drug and food supply for the American people.”
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