Freeze? What freeze? FDA in line for another budget boost


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The Food and Drug Administration is a screaming exception to the Obama administration’s freeze on discretionary spending in the 2011 budget.

Overall, the FDA budget could grow by as much as 23% to just over $4 billion from the current $3.3 billion. But getting all of what the agency wants will require Congress to authorize more than a quarter-billion dollars of new fees on food facilities and generic drug makers.


The healthy increase in the face of the sagging economy and a debt-ridden federal government is a testament to 1) the FDA’s increasingly complex responsibilities monitoring a global supply chain in both food and drugs, 2) to a perception that the agency has been underfunded for many years, and 3) to its new duties as a regulator of tobacco. The FDA’s budget has swelled by 78% since 2008 and no agency programs are on an Office of Management and Budget hit list of line items slated for extinction or downsizing.

The increased spending would allow the FDA to add 1,200 jobs, expanding its workforce by 10%. Key boosts in spending for 2011 include $318 million to improve food safety, $215 million for anti-smoking programs and $100 million to improve the safety of drugs and medical devices.

More than one-third of the 2011 budget -- about $1.5 billion -- would come from user fees paid by businesses that make payments for FDA services such as evaluating new applications for drugs and medical devices. The FDA is collecting about $920 million in user fees this year, so the new figure represents a whopping 63% increase.
The increase in the ‘budget authority,’ or tax-funded component of the budget, is relatively modest by comparison, rising 6% to $2.5 billion from $2.36 billion.

More than half of the uptick in user fees would come from increases in existing fee-based programs, and in statutorily-mandated payments by tobacco companies. But the FDA needs lawmakers to sign off on $220 million in fees on food facilities and $38 million for fees on generic drug applications.

The food fees are a critical component of the FDA’s food safety initiative -- a combination of increased inspections and improved data collection and food tracking technology -- which the agency lists in budget documents as its top priority.

But it’s not clear that the food industry or key members of Congress are on board with the fees.
A House-passed version of food safety legislation includes the charges, but a version passed in November by the Senate Health, Education, Labor and Pensions Committee does not.


Both the chairman of the Senate panel, Iowa Democrat Tom Harkin, and ranking member Mike Enzi of Wyoming, spoke against imposing user fees. “If this is something for public protection, it’s something we should all pay for,” Harkin said at the time.

A key industry lobbyist, Scott Faber of the Grocery Manufacturers Assn., said that his organization wasn’t necessarily opposed to fees but wanted the money spent on improving food safety science as opposed to facility inspections.

There’s bipartisan support for a reform of the nation’s food safety laws, the admittedly big issue of funding notwithstanding. But a full Senate vote on its version of the food bill has so far been hostage to healthcare overhaul negotiations.
Though it doesn’t have the huge line item of ongoing food, drug and tobacco programs, a $25-million allocation for “advancing regulatory science for public health” is listed among the agency’s top four priorities in its budget document. That’s because, according to the FDA, regulatory science has not kept up with advances in the rest of science:

‘During the past two decades, extraordinary investments have led to revolutionary advances in the biomedical sciences. However, FDA’s scientific expertise and infrastructure have not kept pace with these advances. Today, FDA is relying on 20th century regulatory science to evaluate 21st medical products,” the budget document states.

The goal is to keep up with development in genomics, nanotechnology, wireless medical devices and other cutting-edge science so that the agency can prudently regulate the products developed from it.
-- Andrew Zajac