May 28, 2010
President's FY 2009 budget advances food and medical product safety, and the safety of FDA-regulated imports
The U.S. Food and Drug Administration, part of the U.S. Department of Health and Human Services, is requesting nearly $2.4 billion to
protect and promote public health as part of the President's fiscal year (FY) 2009 budget, a 5.7 percent increase over the budget that the
FDA received for the current fiscal year. The FY 2009 request, which covers the period of Oct. 1, 2008 through Sept. 30, 2009, includes
$1.77 billion in budget authority and $628 million in industry user fees. The budget proposal includes strategic increases to strengthen food
protection, modernize drug safety, speed approval of generic drugs, and improve the safety and review of medical devices. The request also
includes funds to cover cost of living increases for FDA employees that perform the agency's scientific and highly specialized public health
mission. These investments build on the increases that the FDA received for FY 2008 and will help ensure the safety of the food supply and
accelerate the availability of new, safe, and innovative medical products.
The FDA primarily delivers its public health mission through its highly trained professional workforce. During FY 2009, the FDA will
experience a full-time equivalent staff increase of 526. The FY 2009 budget supports additional staff for priority areas such as food defense
and food safety, and drug, blood, and human tissue safety programs. The FDA will also work to assure the safety of domestic and imported
food and medical products by conducting more domestic and foreign inspections and more inspections of high risk foods.
The following are the FDA's key proposed budget increases: Protecting America's Food Supply ($42.2 million); Medical Product Safety and
Development ($17.4 million, $79.0 million user fees); Management Efficiencies - The FY 2009 budget also captures the productivity savings
(-$8.9 million) generated by recent FDA investments and reinvests the savings in priority food safety and medical product programs.
For more information on the President's FY 2009 budget for the FDA, visit: http://www.fda.gov/oc/oms/ofm/budget/documentation.htm
FDA receives modest boost in budget plan
President Bush's proposed 2009 budget falls far short of what many experts say is needed to safeguard the U.S. food supply. The president
on Monday proposed the Food and Drug Administration get $2.4 billion for the 2009 fiscal year starting Oct. 1. If approved by Congress, that
would be a 5.7% increase from the current budget.
The FDA's food-safety program would get a bigger bump, up 6.8% to $662 million. But pay raises and inflation would eat most of the
increase, leaving the FDA with few new resources despite increased concerns about the safety of U.S.-produced food and imported food and
drugs. "At least there's not a substantial cut, but the agency won't be able to do much with food or drug safety," said William Hubbard, a
former FDA associate commissioner who has joined other former FDA officials in urging the agency's budget be doubled over five years.
The FDA, which regulates $1.5 trillion of goods, has faced intense scrutiny in the past 18 months after a spate of recalls, including E. coli-
contaminated spinach grown in California, salmonella-tainted U.S.-made peanut butter and contaminated pet-food ingredients from China
that led to the largest-ever pet-food recall. In November, an outside panel of experts set up by the FDA to assess the agency concluded that
consumers' lives are at risk because the FDA is so underfunded. At a congressional hearing last week, one panel member, former FDA
lawyer Peter Barton Hutt, said the agency needs its funding doubled over two years and its employee count increased by 50%.
Under Bush's proposed budget, the number of full-time FDA employees would jump to 10,501, an increase of 932, or nearly 10%, from fiscal
2007. The number of full-time positions in the FDA's foods program would also increase to 2,810 in fiscal 2009, but that would be down 133
from the 2005 fiscal year. The FDA says it plans to work with the industry to improve food safety, do more domestic and foreign food-plant
inspections and open an office in China, the source of numerous food-safety problems last year. The agency's goals are modest, given the
scope of the world food industry, including 136,000 domestic and 189,000 foreign facilities.
Hubbard says there's a chance that Congress, which has held numerous hearings on food safety in the past year, will bolster the FDA's
budget beyond what Bush has proposed, as it did with the fiscal 2008 budget. If not, the FDA will be "treading water," said Chris Waldrop of
the Consumer Federation of America. (USA TODAY) See http://www.usatoday.com/money/industries/food/2008-02-04-fda-budget-food-
New hospital standards needed for pediatric flu vaccines
A new study published in the February 2008 issue of Pediatrics finds that many children hospitalized for influenza have had a recent,
previous hospitalization that would have provided an easy, convenient opportunity to receive a hospital-based influenza vaccination. The
authors suggest that evaluating and establishing industry standards for flu vaccines for hospitalized children could help prevent additional
hospitalizations and complications from influenza.
In the peer-reviewed article “Hospital-Based Influenza Vaccination of Children: An Opportunity to Prevent Subsequent Hospitalization,” the
research team led by Danielle M. Zerr, MD, MPH, medical director of infection control at Seattle Children’s Hospital and associate professor
of Pediatrics at the University of Washington School of Medicine (UWSOM), evaluated the frequency of previous hospitalizations among
children hospitalized with influenza. Overall, they found that 23% of children hospitalized with influenza and another complicating illness had
a previous hospitalization during the most recent flu-vaccine season. This suggests that reaching those children at highest risk for influenza
complications and reducing rates of pediatric hospitalization for influenza may be aided by providing in-hospital vaccinations when children
are hospitalized during flu vaccine season.
The study looked at five years of hospital discharge data from the Pediatric Health Information System (PHIS) database from 2001 through
2006 to determine how many children hospitalized with influenza or respiratory illness had a previous hospitalization during the most recent
flu-vaccine season. Subjects included newborns through age 18. Researchers found approximately 16% of those hospitalized with influenza
and 23% of those hospitalized with influenza and another underlying condition had previous hospital admissions during the vaccination
season. “This information will help pediatricians recognize hospitalization as an important opportunity to vaccinate the highest-risk children,
and may hopefully prompt the development of hospital-based flu vaccine programs,” said Zerr.
Seattle Children’s has had a long-standing aggressive flu prevention program, offering free flu shots to inpatients, outpatients and staff. In
2007-2008 Seattle Children’s also offered free vaccines to those with close contact with patients such as family members, teachers, day care
staff, nannies and more. For more information see http://www.kidshealth.org/PageManager.jsp?
Lifetime medical costs of obesity may be cheaper than treating fit patients
A new research paper published in PLoS Medicine suggests that preventing obesity might result in increased public spending on medical
care. Many countries are currently developing policies aimed at reducing obesity in the population. However, it is not currently clear whether
successfully reducing obesity will also reduce national healthcare spending or not. Pieter van Baal and colleagues, from the National Institute
for Public Health and the Environment in the Netherlands, created a mathematical model to try to answer this question.
In their study, van Baal and his co-workers created three hypothetical populations of 1000 men and women, all aged 20 years at the start: a
group of obese, never-smoking individuals; a group of healthy-never smoking individuals of normal weight; and a group of smokers of normal
weight. The model produced an estimate of the likely proportion of each group who would encounter certain long term (chronic) diseases,
and then estimated what the approximate cost of medical care associated with each disease was likely to be. The researchers found that the
group of healthy, never-smoking individuals had the highest lifetime healthcare costs, because they lived the longest and developed
diseases associated with aging; healthcare costs were lowest for the smokers, and intermediate for the group of obese never-smokers.
However, the authors argue that although obesity prevention may not be a cure for increasing expenditures, it may well be a cost-effective
cure for much morbidity and mortality and importantly contribute to the health of nations. A Perspective by Klim McPherson, from Oxford
University in the UK, who was not involved in the study, discusses the implications of these findings and comments that “it would be wrong to
interpret the findings as meaning that public-health prevention (e.g., to prevent obesity) has no benefits”; the quality of life experienced by
individuals, and other factors, must also be taken into account when planning interventions aimed at improving public health.
Class 1 Recall: Medtronic Inc. SynchroMed EL Implantable, Infusion Pump
Product: Medtronic Inc. SynchroMed El Implantable, Infusion Pump Models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10,
8627-18, and 8627L-18. The programmable pump is part of the SynchroMed EL Infusion System. The implantable components of the
SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories.
Reason for Recall: There is a potential pump motor stall issue that affects SynchroMed EL infusion pumps with motors that were
manufactured before September 1999. These pumps can stall at a higher rate due to gear shaft wear. If a pump motor stalls, drug delivery
will stop suddenly and without warning. This stoppage will result in loss of therapy, return of the patient’s symptoms, and/or symptoms of
drug underinfusion or withdrawal. Drug withdrawal from Intrathecal Baclofen (ITB) therapy (in the patient’s spine) can cause death if not
treated immediately and effectively.
Consumers with questions may contact Medtronic Neuromodulation Patient Services at 1-800-510-6735. Customers with technical questions
may contact Medtronic Neuromodulation Technical Services at 1-800-707-0933.
For more information see http://www.fda.gov/cdrh/recalls/recall-080307.html
Class 1 Recall: Cordis Corporation Dura Star RX and Fire Star RX PTCA Balloon Catheters
Product: Fire Star RX and Dura Star RX PTCA Balloon Catheters. Products manufactured in Mexico from February, 2007 through
December, 2007 and distributed worldwide from March 26, 2007 through January 8, 2008. Dura Star RX was distributed in the U.S. on
August 29, 2007 and Fire Star RX was distributed in the U.S. on August 31, 2007. All Fire Star and Dura Star lots 13173912 through
13315455, plus 52 additional lots above 13315455 are affected. (No lots above 13329055 are affected).
Reason for Recall: The product has a potential for slow deflation or no deflation of the angioplasty balloon when inserted into the artery or
other blood vessels. This may potentially result in a total blockage of the artery or blood vessels, resulting in a change in the heart rate or
heart rhythm, injury to the heart artery, a heart attack, need for a surgical procedure or death.
Consumers with questions may contact Cordis Inc. at 1-786-313-2000.
For more information see http://www.fda.gov/cdrh/recalls/recall-011408.html
Skytron, AIS RealTime, and Awarepoint announce partnership to improve hospital asset management
Skytron, AIS RealTime, and Awarepoint Corporation announced Skytron Asset Manager, an integrated active RFID asset management and
information resource solution designed to improve hospital patient care, enhance staff productivity and better manage equipment capital and
rental expense. While standard real-time location services (RTLS) provide location tracking and reporting of mobile assets via a web-based
search application, Skytron Asset Manager adds another critical dimension to information on-demand, incorporating operators’ instructions,
maintenance manuals and parts catalogs into the asset tracking RFID platform.
“Not only does the system provide real-time location information of mobile assets, it further integrates the myriad operators’ instructions for
all types of healthcare equipment. Skytron Asset Manager creates a wireless hospital asset management solution which can consolidate
medical equipment information and location needs for both mobile and fixed assets,” said Randy Tomaszewski, Skytron’s vice president of
The Skytron Asset Manager solution further integrates with Skytron’s SkyVision operating room video and data system to provide total
equipment information at the point of care. With it, users can track the location and status of equipment and people, plus have operation,
maintenance and technical manuals at their immediate fingertips, without leaving the operating room.
“In addition to tracking the location of mobile equipment and obtaining quick access to product information, the system can be installed within
a matter of days with no disruption to patient and staff. The software user interface is fully customizable and easy to use so that hospital staff
can be trained in just a matter of a few minutes,” said Tim Bayer, President of AIS RealTime.
Under the new partnership, Skytron’s extensive North American network of independent distributors will sell, install and support the patented
active RFID-RTLS technology, powered by Awarepoint’s exclusive ZigBee sensor network. Sensors simply plug into electrical outlets to form
the Awarenet mesh network. Once the sensors are plugged in, the mesh network forms automatically to track small battery-powered tags
that are attached to equipment or people. Users track location and detailed product information from any accessible hospital-based
For more information see http://www.skytron.us/
The Council of Supply Chain Executives announces new supply chain member
The Council of Supply Chain Executives (The Council) announces the addition of Steve Pitzer, System Director, Supply Chain Management
for CHRISTUS Health, to its roster of nationally acclaimed supply chain executives. Pitzer is responsible for all aspects of supply chain
management activities for more than 40 hospitals and facilities in six American states and Mexico, with assets of more than $3.4 billion.
The Council is an organization that allows supply chain executives from across the country to assemble together to offer their best practices
and experiences to their peers and to healthcare suppliers in small focus group panels. The Council offers various healthcare suppliers a
collaborative forum to ask for feedback and advice from the country’s leading supply chain executives in a neutral and constructive
The Council of Supply Chain Executives will convene next on November 6-7, 2008 in Franklin, TN. Due to the unique nature and format of
The Council of Supply Chain Executives, only a limited number of healthcare suppliers can attend. For more information see