Regulatory Focus™ > News Articles > New Funding Required to Allow FDA to Face 'Brave New World' of Global Supply Chains, Says Hamburg

New Funding Required to Allow FDA to Face 'Brave New World' of Global Supply Chains, Says Hamburg

Posted 18 April 2013 | By Alexander Gaffney, RAC

US Food and Drug Administration (FDA) Commissioner Margaret Hamburg has found herself in front of a congressional hearing for the second time this week, this time under far more favorable circumstances explaining why the agency deserves the funding it receives and-hopefully-more of it.


In prepared testimony delivered on 18 April 2013 to the Senate Committee on Appropriations, the congressional panel with principal authority over FDA's budget, Hamburg observed how the committee needs to keep up with the realities of a changing world.

"Not that long ago, FDA's job was to oversee a largely domestic market of food and medical product suppliers," Hamburg said. Most of the facilities in which these products were stored and manufactured were within our borders and relatively easy to inspect and oversee," Hamburg explained.

But Hamburg said the agency is no longer operating in the same environment it was a decade ago, or even a few years ago. Thanks to trends in globalization, the products and companies it now regulates are spread across every geography and country imaginable, creating new strains on both its resources and its mission to ensure marketed products are safe and effective.

"We have now entered a brave new world-a world in which, very soon, the majority of our food and medical products will come in whole or in part from foreign countries. In the last 10 years, the number of imported shipments of FDA-regulated products has skyrocketed," she explained. And with that increase has come additional counterfeiting and fraud, as people around the world attempt to profit from the trust and spending power of US consumers.

The agency is also taking on new areas of responsibility, such as an increased emphasis and investment in regulatory science initiatives and technological upgrades meant to increase its regulatory capacity.

A Value-Driven Agency?

Hamburg's testimony reflects many of the same sentiments outlined during last year's budget hearing: An increased scope of responsibility, the important work that FDA does to protect consumers, and the difficulties of regulating products in the global economy.

But in a tight fiscal environment, a new talking point has made its way into Hamburg's remarks: The value that FDA provides to the US taypayer.

In fact, the US pays more to consume snack chips than it does to fund FDA, Hamburg said-a bargain considering FDA oversees one fifth of all US domestic consumer spending. "And putting money into FDA is a smart investment," she continued. "For about two cents a day, Americans get an extraordinary array of public health benefits, including: (1) life-saving medicines approved as fast or faster than anywhere in the world, (2) confidence in the medical products they rely on daily, and (3) a food supply that is among the safest in the world. But maintaining this level of performance for the American public, especially related to food safety, demands a fully-funded FDA."

That argument could resonate better than most in a Congress that is now looking to cut money wherever and in whatever ways it can. Even maintaining its current level of funding might be seen as a victory under such austere circumstances.

Need for More Funding

Hamburg, though, isn't arguing for equal funding; she's arguing for more of It, explaining that her job has become "increasingly demanding."

"We are in the midst of dramatic technological and market-based changes in the way that foods, drugs, biologics, and devices are produced-from personalized medicine and nanotechnology to the globalization of our food and medical product supplies," she said. "Congress has also continued to pass new laws and expand our responsibilities," she observed, including the FDA Safety and Innovation Act (FDASIA) and the Food Safety Modernization Act (FSMA), among others.

It would be nice, she said, if those responsibilities came with added resources given that without them, their ability to complete their already substantial duties is diminished. Without that funding, her testimony implied, the agency would not be able to fulfill its desire to get innovative products to market as quickly as possible.

Budget Request

In light of these challenges and the overall value of FDA, Hamburg said the agency was requesting $4.7 billion in total spending authority, an $821 million increase relative to the prior year. The good news for legislators, however, is that all but 6% of that request-$51 million-comes from user fees. Some areas, like appropriated spending for drugs, biologics and devices would increase by more than $15 million, while others, such as new inspectors to be sent to China, would receive $10 million in new funding.

Hamburg concluded by calling FDA's oversight capabilities "indispensable to the health and well-being of every American."

"We carry out our broad public health responsibilities effectively and with few taxpayer dollars-even as those responsibilities are expanding as a result of new legislation, technological advances, and a globalized marketplace," she said. Her budget, she added, reflects both the needs of the agency and the expectations of the public for safety and effective products.

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