FDA asks Congress for 33 percent budget increase

The Food & Drug Administration asks Congress to boost its fiscal 2012 budget by a third over 2010, seeking $4.3 billion to fund its oversight of the medical device, pharmaceutical and food production industries.

It’s time once again for the annual Beltway Budget Brouhaha and the Food & Drug Administration is wading right in with a request for a 33 percent boost.

The federal watchdog agency is pitching Congress and President Barack Obama for $4.3 billion for fiscal 2012, about a third more than it got in 2010. The FDA’s fiscal 2011 request was for $4.03 billion, a 23 percent increase over 2010.

Dr. Margaret Hamburg, Obama’s pick to lead the agency, defended that increase, calling it “crucial to the modernization” of the agency, which regulates nearly 20 percent of all products purchased and consumed in the U.S. Hamburg used similar rhetoric to back up the 2012 request.

“The breadth of this mandate means that FDA responsibilities continue to grow. The new budget contains new resources so that FDA can fulfill its growing responsibilities to the American public,” Hamburg said in prepared remarks.

The FDA is pushing a four-pronged initiative for investing investing in “food-borne illness prevention, medical product safety and countermeasures:”

1. The “Transforming Food Safety and Nutrition Initiative,” which accounts for $324 million of the proposed increases, is designed to fund the implementation of the the Food Safety Modernization Act and help Americans to make healthier dietary choices.
2. The”Protecting Patients Initiative” would add $124 million to the FDA’s 2012 budget. The program is designed to “develop a pathway for approving bio-similars, which are biological drugs shown to be highly similar to, and without clinically meaningful differences with, an FDA-approved reference biological product.”
3. The “Advancing Medical Countermeasures Initiative” funded with a $70 million increase, would support the development of medical counter-measures for responding to national security threats such as “chemical, biological, radiological and nuclear threats, as well as naturally emerging diseases such as pandemic influenza.”
4. The “Regulatory Science and Facilities Initiative,” representing $49 million of the increase, would allow the agency to “strengthen its core regulatory scientific capacity that supports all elements of the FDA mission,” and would “help harness advances in science and technology to modernize and streamline the regulatory pathway and improve the review and approval process for products relying on new and emerging technologies.”

Fiscal 2012 runs from Oct. 1, 2011, through Sept. 30, 2012.