BETHESDA, MD 26 February 2010—Federal officials say their agencies, regardless of how the health care reform process unfolds, will continue to support programs to improve the overall quality of care that Americans receive.
For example, tens of millions of dollars in funding from the American Recovery and Reinvestment Act of 2009 have allowed the Department of Health and Human Services (HHS) to support community programs to improve nutrition and combat obesity, smoking, and other chronic health issues, according to the agency.
HHS Secretary Kathleen Sebelius, speaking February 8 at a Washington, D.C., health policy conference sponsored by AcademyHealth, said the nation has "a huge problem" with chronic diseases.
In consequence, she said, "there is a huge opportunity to change our health care cost estimate into the future if we can deal with some of those underlying causes," like smoking and obesity.
In all, HHS had spent nearly $50 billion in recovery funds by the end of January to support a variety of disease-prevention programs and other initiatives. Included in this figure is money for information technology (IT) projects, some of which have produced measurable results, Sebelius said.
She said one health system has spent stimulus money on technology to track and ultimately triple osteoporosis screening rates for women. Another has used IT to double the rate of regular foot and eye screenings among patients with diabetes.
"We`ve already seen systems in place in pockets of the country where very positive patient outcomes are achieved because of the use of technology in health systems," Sebelius said.
Also speaking at the conference was FDA Commissioner Margaret Hamburg. She said she wants her agency to function as a critical component of public health, not just a regulatory body.
"As a public health agency, FDA must work to prevent problems, to balance risks and benefits, and to monitor outcomes," Hamburg said. "My goals are to modernize FDA`s work in all these areas and to strengthen the agency`s credibility in doing so."
She said last year`s warnings to consumers to avoid eating pistachios exemplify FDA`s focus on prevention. The warnings were issued after salmonella contamination was detected in some pistachios but before FDA had completed its investigation. Hamburg said this early action meant that no illness was reported as a result of the outbreak.
Hamburg contrasted this to the agency`s slower response to a peanut-related salmonella outbreak in 2008–09, which sickened hundreds and may have contributed to eight deaths, according to federal data.
"When we see problems, we cannot be afraid to take the actions necessary to stop them in their tracks," Hamburg said. "Too often, the agency has found itself engaging in back-and-forth with companies and with lawyers while serious health and safety problems remain in limbo. My view is that when the health of the public is jeopardized, we have a duty to warn and to act."
She said FDA is committed to preventing problems associated with medical products as well as foods and ensuring that these products are as safe and effective as possible.
FDA`s regulatory authority to ensure the safe use of drugs and devices was expanded through the Food and Drug Administration Amendments Act of 2007. With enactment of that law, FDA gained the power to require postmarketing studies and clinical trials, force manufacturers to change product labeling, and require the use of risk evaluation and mitigation strategies.
A law passed last year gave FDA the power to protect the public health by regulating the manufacturing and marketing of tobacco products.
These actions by Congress have given FDA "strong regulatory powers," Hamburg said. But she added that the agency also serves as a gatekeeper "with a major role in getting new products into stores, pharmacies, and hospitals."
When the need arises, FDA can move very promptly to ensure that needed products reach the public, Hamburg said. She said the rapid approval of H1N1 vaccines and diagnostics during the recent influenza pandemic demonstrates FDA`s ability to "clear red tape to get needed products to consumers in emergency situations."
Even in the absence of a public health emergency, Hamburg said she wants FDA to improve "regulatory science" to streamline its review procedures. This could lead to more rapid recognition of the benefits of promising therapies or more rapid determination that a product under review is not beneficial.
One way FDA supports drug development is through the agency`s Critical Path Initiative. As part of this project, FDA validates genomic biomarkers of drug response and toxicity that allow manufacturers to gather important data during preclinical and early clinical studies. Hamburg said FDA has sanctioned 70 scientifically valid biomarker tests so far and is determined to pursue this and other science-based programs.
"A fundamental priority must be strengthening science," she said. "We must ensure that we always use the best possible science and data to guide our decision-making and our thinking. We must get advice from the best possible experts and always be prepared to change our minds in the face of emerging science."
Hamburg said FDA has long lacked the necessary resources to fulfill its mission.
"But I do hope and believe that we are turning a corner," she said. "There`s growing appreciation that it`s in everyone`s best interest to have a strong, fully functional FDA. And we are embarking on a new era of public health protection with the support of the White House and of Congress."
The Obama Administration has proposed $2.5 billion in funding for FDA during the 2011 fiscal year, up from $2.36 billion in fiscal-year 2010. An additional $1.5 billion is expected to come from user fees paid to the agency by manufacturers of food, drugs, medical devices, and tobacco products.
The administration has proposed $900 billion in total HHS funding for the upcoming fiscal year. About $20 billion of that amount consists of estimated funds allocated for recovery act programs.
