Federal budget proposal boosts food safety, biodefense

Feb 1, 2010 (CIDRAP News) – The Obama administration today released its $3.8 trillion budget for the 2011 fiscal year, trimming some public health programs but posting notable gains for food safety and bioterror countermeasures.

Proposed increases in two key public areas come just days after the Obama administration instituted a 3-year freeze on nonsecurity-related funding that it says will save $250 billion over the next decade. Overall, the US Department of Health and Human Services's (HHS's) share of the proposed federal budget is $81.3 billion, a $1.7-billion increase from the previous year.

The spending plan, if passed, takes effect in October 2010 when the next fiscal year begins. HHS secretary Kathleen Sebelius unveiled the HHS budget today at a press briefing. She said it includes key components to continue rebuilding the public health infrastructure, so that it is "a true healthcare system that promotes better health all the time."

Alongside other measures, such as reducing healthcare fraud and improving health information technology, Sebelius singled out food safety as an area that will receive a sizeable increase. The budget would target $318 million more to the US Food and Drug Administration (FDA) for food safety efforts.

In March 2009 President Barack Obama appointed a cabinet-level panel, the Food Safety Working Group, to advise him on ways to revitalize the nation's food safety laws in the wake of a troubling spate of foodborne disease outbreaks.

Last July the US House of Representatives passed the Food Safety Enhancement Act, which would give the FDA more power to and resources to prevent outbreaks. The legislation awaits Senate action.

She also noted that the budget includes $500 million to upgrade the nation's countermeasures against bioterror threats. The boost comes just days after a Congressional commission reported that the nation has done little over the past year to improve its capability to respond to a biological weapons attack.

Funds for new food safety initiatives
New funding for food safety, a 30% increase from last year, will help the FDA and the US Centers for Disease Control and Prevention (CDC) focus on prevention, strengthen surveillance and enforcement, and improve response, all key priorities of Obama's Food Safety Working Group.

The funds would help integrate federal and state food safety activities, pilot new tracking and tracing technology, deliver analytical tools to help officials deploy safety strategies, modernize lab capacity, and train and hire more foreign and domestic inspectors.

FDA commissioner Margaret A. Hamburg, MD, said in a statement today that the new 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," she said.

At a press briefing today, Patrick McGarey, director of the FDA's budget office, said the increase consists of $79.8 million in budgetary authority and $238 million in user fees from programs such as inspection, registration, and export certificates.

Bill Marler, a prominent food-safety attorney based in Seattle, told CIDRAP News today that it would take more than $1 billion to fund all of the measures suggested in new food safety legislation, and the new funds in the proposed budget cover only about a fourth of that amount. He said he understands the severe economic situation the nation is in, and he worries that passage of ambitious new legislation without adequate resources may further burden the FDA.

He cautioned that the user fees that appear to be a key component of FDA's 2011 budget have not been signed into law. Marler said the House passed the user fee legislation in July along with the funding mechanism, but the Senate version still awaits a vote and does not spell out the funding component.

The US Department of Agriculture's (USDA's) Food Safety and Inspection Service (FSIS) would see an increase of $18 million over fiscal year 2010 funding, according to the agency's budget documents. Marler said that money is thought to be earmarked for the testing of raw products, red meat, and poultry. However, he said it's not clear if the increase, considered small, is enough to make a difference.

The USDA's proposed budget includes $40 million, an increase of $13 million, to continue deployment and enhancement of the FSIS public health information infrastructure. It also said new funding will allow the FSIS to improve its foodborne pathogen surveillance by expanding Hazard Analysis and Critical Control Points (HACCP) regulatory sampling.

CDC budget reflects slight dip
Jeff Levi, PhD, executive director of Trust for America's Health (TFAH), a nonprofit, nonpartisan advocacy group based in Washington, DC, told CIDRAP News that core funding for the CDC's preparedness and response activities appears flat, and that the agency's budget reflects a $9 million cut, which he said is a "marginal decline" of about 1%, down to $183 million.

"The CDC has done remarkably well, especially considering we're in the middle of a budget freeze," he added.

According to HHS budget documents, the supplemental budget appropriation passed in the summer of 2009 to fund pandemic H1N1 response included $3 billion to purchase vaccine, enough for 600 million doses, two for each American. Because only one dose was required for most people, some of the funding previously set aside for vaccine can be directed to other pandemic activities.

Federal officials are earmarking the remaining money, combined with 2010 and 2011 appropriations, toward investments such as next generation recombinant and molecular vaccine technology and expansions in domestic vaccine manufacturing capacity.

Levi said in a statement today that the budget proposal would trim $3 million from state and local preparedness, down to $758 million. "As the past year's effort around H1N1 has demonstrated, we need continued and increased investment in public health preparedness or we will be caught off stride again at the next crisis," he said "This is especially hard at a time when state and local budgets are so hard-hit."

"Obviously, we would prefer to see larger increases; however, this budget, combined with large investments about to be released under the American Recovery and Reinvestment Act (ARRA), will significantly increase the capacity of communities to respond to our pressing prevention needs," Levi said in the statement.

"However, without a long-term commitment of resources, we'll be unable to maintain the short-term gains we were able to achieve with the ARRA funds, and as efforts to balance the budget continue, we could easily fall back into an annual cycle of chronic underfunding of public health prevention and preparedness programs," he added.

He said TFAH has called for a more reliable and dedicated funding mechanism for prevention and public health to be included in House and Senate healthcare reform legislation.

BARDA may get a lift
The Obama administration's budget would boost funding for the Biomedical Advance Research and Development Authority (BARDA) by $136 million to support the next generation of medical countermeasures. BARDA coordinates and administers federal efforts to develop and obtain vaccines and medications to mitigate the impact of biological, chemical, radiological, and nuclear threats.

According to HHS documents, the proposed budget would give BARDA more flexibility to target resources toward the most promising countermeasure candidates, through advanced development or acquisition through Project BioShield.

The budget would allow the Assistant Secretary for Preparedness and Response to expand the US Postal Service's countermeasure dispensing demonstration project from four planned in fiscal year 2010 to eight in fiscal year 2011.

See also:

HHS 2011 budget in brief
http://www.hhs.gov/asrt/ob/docbudget/2011budgetinbrief.pdf

USDA 2011 budget documents
http://www.obpa.usda.gov/budsum/FY11budsum.pdf

FDA 2011 budget information
http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/BudgetReports/default.htm

Feb 1 TFAH press release
http://healthyamericans.org/newsroom/releases/?releaseid=202

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