Hamburg: $755 million FDA budget increase "crucial"

March 11, 2010 by MassDevice staff

Food & Drug Administration chief Margaret Hamburg defended the agency's 23 percent budget increase request for 2011 before a senate panel March 10, saying that the $755 million boost was "crucial to the modernization" of the federal watchdog agency, which regulates nearly 20 percent of all products purchased and consumed in the United States.

In a mostly civil hour of testimony before a Senate appropriations subcommittee, Hamburg reiterated her talking points on the need for increased scrutiny of food, drugs and medical devices. It was her first time testifying before the appropriations committee since being sworn in eight months ago.

In February, the FDA requested $4.03 billion from Congress for fiscal 2011. The FDA's FY2010 budget came in at $3.28 billion, itself a 17.5 percent increase over the prior year's $2.79 billion allotment.

Appropriations Committee chairman Sen. Herb Kohl (D-Wis.) agreed that the budget increases were important, but said the committee had some reservations.

"We know that these increases are important, but we have concerns," Kohl said. "Our goal is to protect the important gains we've made over the last few years."

However, he said, the committee must have restraint and act in a "spirit of austerity," adding, "We must do more with less."

For her part, Hamburg stressed the necessity for increased budget requests for items including protecting the agency's patient safety and regulatory science initiatives, for which the FDA requested an additional $100 million and $25 million, respectively.

"Building strong regulatory science capacity is vital to the health of the nation, our economy and the global competitiveness of the country," Hamburg told the panel.

The agency would also use the increased funding to strengthen coordination and its presence alongside foreign regulatory agencies to monitor the increasing number of drugs, devices and biologics that are being produced outside of the U.S., she added. And the agency will look to help accelerate the transfer of innovations from the laboratory to the marketplace.

Hamburg also said the agency will increase user fees for some of its operations, including re-inspections of facilities that produce medical products and companies that make generic drugs.

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