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FDA Budget Could Hike User Fees, Overseas Inspections

Also, expect more frequent and stricter enforcement

Michael Causey
Tue, 03/13/2012 - 12:49
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Budget-conscious firms that do business in China and elsewhere outside the United States may not like what they find in the Food and Drug Administration’s (FDA) request in the Budget of the United States Government, Fiscal Year 2013.

While it is one of the few agencies that could see its overall budget increase a bit this year, much of that increase will be borne by industry. Broadly speaking, the FDA is requesting a budget of $4.5 billion as part of the fiscal year (FY) 2013 budget—a 17-percent increase over the FDA-enacted budget for FY 2012. Industry user fees would fund 98 percent of the proposed budget increase. The FY 2013 request covers the period from Oct. 1, 2012 through Sept 30, 2013.

“These are austere budget times, and the FDA budget request reflects this reality,” says Margaret A. Hamburg, M.D., the commissioner of FDA. “Our budget increases are targeted to strategic areas that will help speed the availability of new medical products, address the challenges of increased globalization, and allow FDA to fulfill 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.”

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