MASSDEVICE ON CALL — A U.S. House of Representatives committee slammed the FDA over the $1 billion in unobligated user fees the watchdog agency is carrying on its books.
"While Congress did allow for some exemptions from fiscal year limitations and for some amounts to be carried forward into subsequent fiscal years, it could not have been anticipated that FDA would be carrying in excess of $1,000,000,000 in unobligated user fees halfway into any fiscal year," according to a report from the House Appropriations Committee. "In the tobacco user fee program alone, the fiscal year 2012 unobligated balance that carried over into fiscal year 2013 was $600,000,000. While FDA estimates this figure will drop to $250,000,000 by the end of fiscal year 2013, the committee remains skeptical that this will occur."
Manufacturers pay the user fees in return for reviews of their products; the most recent user fee authorization for medical devices called for the agency to meet timeliness benchmarks to reduce the backlog of FDA applications
The House panel wants the agency to categorize each fee and provide "a detailed explanation of what accounts for the balance and what the balance will be used for," according to the report.
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