In a hearing with a Senate subcommittee this week, FDA Commissioner Margaret Hamburg asked for additional funding to counter the $209 million in mandatory cuts to agency that were made as a part of the so-called “sequestration.”
While the FDA receives a portion of its funding through taxpayers, the majority comes from user fees paid by companies looking to speed the evaluation and potential authorization of their new products.
“FDA is a true bargain among federal agencies,” Hamburg said. “Americans each pay about $8 a year for FDA’s appropriations.”
“Americans get an extraordinary array of public health benefits” for about two cents a day, she added.
To the surprise of some observers, the mandatory cuts incorporate the withholding of $83 million in user fees. The commissioner suggested that these fees be exempted from the sequester cuts based on current goals for product reviews.
“We will not be able to use all those user fees to achieve the performance goals negotiated with industry,” she said.
She added that the growing challenges associated with globalization are forcing her agency to transform the way it approaches drug safety and potential terrorist threats.
“If we are to continue to promise Americans a safe food and drug supply, FDA must continue to transform itself, from a primarily domestic agency to one that uses innovative global strategies to secure a vast global supply chain,” Hamburg said.
Cuts to impact additional FDA oversight
The sequester cuts could also impact the new approach the FDA is taking toward special compounding pharmacies. A deadly meningitis outbreak that was traced to one such pharmacy in Massachusetts had spurred calls for additional FDA oversight that is expected to cost an additional $3 million.
While Congress has yet to legislate any additional oversight of these pharmacies, Hamburg said the FDA will more aggressively use authority it already has.
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