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Hamburg wants user fees exempt from sequester

April 20, 2013 12:20 AM UTC

FDA Commissioner Margaret Hamburg said on Thursday that she supports exempting user fees from sequestration. She said sequestering fees would hurt FDA's ability to meet negotiated performance goals. Hamburg also said industry "clearly expects" user fees will be used to meet goals and performance measures, and that she is "very concerned" about the potential negative effects of sequestration on future negotiations for PDUFA reauthorization. "It's something to think about next time we sit across the table to discuss these fees," said Hamburg. Her comments came during testimony before a subcommittee of the U.S. Senate Committee on Appropriations to discuss the agency's proposed FY14 budget.

President Obama released his FY14 budget proposal earlier this month. The proposal includes a requested bump in funding for FDA that would come largely from industry. Overall, the administration is requesting $2.6 billion in base appropriations -- taxpayer funding -- for FDA not including user fees, or $4.7 billion including user fees (see BioCentury Extra, April 10). ...