FDA Requesting $4.03 Billion for Fiscal Year 2011

By Daniel R. Matlis

The FDA is requesting $4.03 billion to promote and protect public health as part of the fiscal year 2011 budget. This represents a 23 percent increase over the agency’s current $3.28 billion budget and includes a $146 million increase in budget authority and $601 million in industry user fees.

According to FDA Commissioner Margaret A. Hamburg, M.D. “The FY 2011 resources will strengthen our ability to act as a strong and smart regulator, protecting Americans through every stage of life, many times each day. This budget supports the ability for patients and families to realize the benefits of science that are yielding revolutionary advances in the life and biomedical sciences.”

The budget request reflects commissioner Hamburg’s resolve to transform food safety practices, improve medical product safety, protect patients and modernize FDA regulatory science to advance public health. This budget also funds FDA’s new regulatory authority over cigarettes and other tobacco products.

According to the agency, four initiatives are the major highlights for the FY2011 budget increases:

Transforming Food Safety (+ $318.3 million)
The Transforming Food Safety Initiative reflects President Obama’s vision of a new food safety system to protect the American public. The FDA will set standards for safety, expand laboratory capacity, pilot track and trace technology, strengthen its import safety program, improve data collection and risk analysis and begin to establish an integrated national food safety system with strengthened inspection and response capacity.

Protecting Patients (+ $100.8 million)
The Protecting Patients Initiative advances the Obama Administration’s priorities for safe, quality health care for all Americans. The resources in this initiative will support the safety of drugs, devices, and vaccines, as well as the Nation’s blood supply. The FY 2011 resources will also strengthen the FDA’s ability to act as a strong and smart regulator to address medical product safety challenges in the years ahead.

Advancing Regulatory Science (+ $25.0 million)
Advancing Regulatory Science builds on President Obama’s commitment to harness the power of science for America’s benefit. During the past two decades, extraordinary investments have led to revolutionary advances in the life and biomedical sciences. Many key discoveries, however, have yet to translate into real therapies for patients. The FY 2011 budget will allow the FDA to begin to strengthen its core scientific capacity. This investment will allow the FDA to identify improved pathways to product development and approval for new technologies that offer promising new opportunities to diagnose, treat, cure and prevent disease.

Tobacco (+ $215.0 million)
An increase in tobacco user fees will allow the FDA to continue to implement the Family Smoking Prevention and Tobacco Control Act. Preventing youth from using tobacco and helping Americans quit, promoting public understanding of the harmful constituents of tobacco products, developing the foundation of science for regulating tobacco, and regulating tobacco to reduce the toll of tobacco-related disease, disability and mortality are tobacco program priorities for FY 2011.

In our December 2009 article “What to Expect from FDA in 2010” I stated that time would tell how the FDA’s current vision would affect industry and consumers. It is evident that through this budget request, Commissioner Hamburg is seeking the resources needed to achieve her vision for the FDA as a Public Health Agency. As she stated shortly after she took office, FDA’s role is to “Minimize Risks Through Education, Regulation, and Enforcement.”

The complete FDA FY2011 budget is available at: http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/BudgetReports/UCM199447.pdf

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